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Primary outcomes
#1
At the begining of the study, after 12 weeks and 24 weeks
At the begining of the study, after 12 weeks and one year ( At the begining the duration of the follow up was 6 months but after covid 19 pandemic, sampling was incomplete and the time of final assessment was changed from 6 month to one year. According to ethnic principles and to avoid endangering patients to come to Rasool Akram Hospital, which is the center of Corona, final assessments were performed by video call at home and inevitably, unmeasurable variables at home were eliminated in the final evaluation.)
At the begining of the study, after 12 weeks and 24 weeksone year ( At the begining the duration of the follow up was 6 months but after covid 19 pandemic, sampling was incomplete and the time of final assessment was changed from 6 month to one year. According to ethnic principles and to avoid endangering patients to come to Rasool Akram Hospital, which is the center of Corona, final assessments were performed by video call at home and inevitably, unmeasurable variables at home were eliminated in the final evaluation.)
ابتدای مطالعه ، 12 هفته بعد و 24 هفته بعد
ابتدای مطالعه، 12 هفته بعد و یک سال بعد( در ابتدا دوره ی فالوآپ 6 ماه بود اما با بروز پاندمی covid 19، نمونه گیری ناتمام باقی ماند و زمان ارزیابی نهایی از 6 ماه به یکسال تغییر پیدا کرد. با توجه به اصول اخلاقی و برای به خطر نیفتادن بیماران برای آمدن به بیمارستان رسول اکرم که سانتر کرونا میباشد ارزیابی های نهایی با تماس تصویری در منزل انجام شد و به ناچار متغیرهای غیرقابل اندازه گیری در منزل در ارزیابی نهایی حذف گردید.)
ابتدای مطالعه، 12 هفته بعد و 24 هفتهیک سال بعد( در ابتدا دوره ی فالوآپ 6 ماه بود اما با بروز پاندمی covid 19، نمونه گیری ناتمام باقی ماند و زمان ارزیابی نهایی از 6 ماه به یکسال تغییر پیدا کرد. با توجه به اصول اخلاقی و برای به خطر نیفتادن بیماران برای آمدن به بیمارستان رسول اکرم که سانتر کرونا میباشد ارزیابی های نهایی با تماس تصویری در منزل انجام شد و به ناچار متغیرهای غیرقابل اندازه گیری در منزل در ارزیابی نهایی حذف گردید.)
#2
At the begining of the study , after 12 weeks and 24 weeks
At the begining of the study , after 12 weeks (Inevitably final assessment was eliminated due to covid 19 pandemic)
At the begining of the study , after 12 weeks and 24 weeks(Inevitably final assessment was eliminated due to covid 19 pandemic)
ابتدای مطالعه ، 12 هفته بعد و 24 هفته بعد
ابتدای مطالعه ، 12 هفته بعد ( ارزیابی نهایی به ناچار به دلیل پاندمی کووید 19 حذف شد)
ابتدای مطالعه ، 12 هفته بعد و 24 هفته بعد( ارزیابی نهایی به ناچار به دلیل پاندمی کووید 19 حذف شد)
Secondary outcomes
#1
At the begining of the study , after 12 weeks and 24 weeks
At the begining of the study , after 12 weeks
At the begining of the study , after 12 weeks and 24 weeks
ابتدای مطالعه ، 12 هفته بعد و 24 هفته بعد
ابتدای مطالعه ، 12 هفته بعد
ابتدای مطالعه ، 12 هفته بعد و 24 هفته بعد
Inclinometer Device and X-ray (X-ray only at the begining and 24 weeks)
Inclinometer Device and X-ray (X-ray only at the begining and one year)
Inclinometer Device and X-ray (X-ray only at the begining and 24 weeksone year)
دستگاه اینکلینومتر و رادیوگرافی ( رادیوگرافی تنها در ابتدا و 24 هفته)
دستگاه اینکلینومتر و رادیوگرافی ( رادیوگرافی تنها در ابتدا و یک سال بعد )
دستگاه اینکلینومتر و رادیوگرافی ( رادیوگرافی تنها در ابتدا و 24 هفتهیک سال بعد )
Intervention groups
#1
Intervention group 1: Spinomed Orthosis plus Back School Program Exercise Therapy: The spinomode orthosis is made of a dorsal, pelvic belt and ventricle.The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. This orthosis is adjustable and can be used for different sizes. The latest version of Spinomed Orthosis is available in various sizes from the German Medi Company. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months. It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months, which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the second 3 months, and will be followed up by phone every month.
Intervention group 1: Spinomed Orthosis plus Back School Program Exercise Therapy: The spinomode orthosis is made of a dorsal, pelvic belt and ventricle.The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. This orthosis is adjustable and can be used for different sizes. The latest version of Spinomed Orthosis is available in various sizes from the German Medi Company. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic). It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month.
Intervention group 1: Spinomed Orthosis plus Back School Program Exercise Therapy: The spinomode orthosis is made of a dorsal, pelvic belt and ventricle.The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. This orthosis is adjustable and can be used for different sizes. The latest version of Spinomed Orthosis is available in various sizes from the German Medi Company. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic). It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the second 3next 9 months, and will be followed up by phone every month.
گروه مداخله: گروه ارتوز اسپاینومد به همراه ورزش درمانی (Back School): ارتوز اسپاینومد از یک بخش پشتی، کمربند لگنی و ولکرو ساخته شده است. بخش اصلی ایجاد کننده فشار بر روی ستون مهرهها بخش پشتی میباشد که جنس آن فلزی است و پوششی نرم این بخش را میپوشاند. این ارتوز قابل تنظیم است و می توان آن را برای سایزهای مختلف استفاده نمود. آخرین نسخه تهیه شده از ارتوز اسپاینومد در سایز های مختلف توسط کمپانی مدی آلمان تهیه شده است. در جلسه اول توسط ارتوزیست ارتوز اسپاینومد متناسب با جثه افراد تجویز و نحوه استفاده از آن به افراد آموزش داده میشود تا روزانه 2 ساعت به مدت 6 ماه از ارتوز استفاده کنند. در مراجعات سه ماهه اول هر دو هفته یکبار ارتوز تنظیم مجدد و پیشرفت داده میشود. . ورزش درمانی Back School Program . روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار رد این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 3 ماهه دوم به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد.
گروه مداخله: گروه ارتوز اسپاینومد به همراه ورزش درمانی (Back School): ارتوز اسپاینومد از یک بخش پشتی، کمربند لگنی و ولکرو ساخته شده است. بخش اصلی ایجاد کننده فشار بر روی ستون مهرهها بخش پشتی میباشد که جنس آن فلزی است و پوششی نرم این بخش را میپوشاند. این ارتوز قابل تنظیم است و می توان آن را برای سایزهای مختلف استفاده نمود. آخرین نسخه تهیه شده از ارتوز اسپاینومد در سایز های مختلف توسط کمپانی مدی آلمان تهیه شده است. در جلسه اول توسط ارتوزیست ارتوز اسپاینومد متناسب با جثه افراد تجویز و نحوه استفاده از آن به افراد آموزش داده میشود تا روزانه 2 ساعت به مدت 6 ماه ( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) از ارتوز استفاده کنند. در مراجعات سه ماهه اول هر دو هفته یکبار ارتوز تنظیم مجدد و پیشرفت داده میشود. . ورزش درمانی Back School Program . روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار رد این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 9 ماه بعدی به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد.
گروه مداخله: گروه ارتوز اسپاینومد به همراه ورزش درمانی (Back School): ارتوز اسپاینومد از یک بخش پشتی، کمربند لگنی و ولکرو ساخته شده است. بخش اصلی ایجاد کننده فشار بر روی ستون مهرهها بخش پشتی میباشد که جنس آن فلزی است و پوششی نرم این بخش را میپوشاند. این ارتوز قابل تنظیم است و می توان آن را برای سایزهای مختلف استفاده نمود. آخرین نسخه تهیه شده از ارتوز اسپاینومد در سایز های مختلف توسط کمپانی مدی آلمان تهیه شده است. در جلسه اول توسط ارتوزیست ارتوز اسپاینومد متناسب با جثه افراد تجویز و نحوه استفاده از آن به افراد آموزش داده میشود تا روزانه 2 ساعت به مدت 6 ماه ( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) از ارتوز استفاده کنند. در مراجعات سه ماهه اول هر دو هفته یکبار ارتوز تنظیم مجدد و پیشرفت داده میشود. . ورزش درمانی Back School Program . روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار رد این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 3 ماهه دوم9 ماه بعدی به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد.
#2
Intervention group 2: Elderly Orthosis plus Back School Program Exercise Therapy Spinal Elderly Orthosis: This orthosis is made of a dorsal, pelvic belt and ventricle. The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. The latest version of Spinal Elderly Orthosis is produced by the Iranian company Savad Teb. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months. It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months, which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the second 3 months, and will be followed up by phone every month.
Intervention group 2: Elderly Orthosis plus Back School Program Exercise Therapy Spinal Elderly Orthosis: This orthosis is made of a dorsal, pelvic belt and ventricle. The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. The latest version of Spinal Elderly Orthosis is produced by the Iranian company Savad Teb. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic) . It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic) , which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month.
Intervention group 2: Elderly Orthosis plus Back School Program Exercise Therapy Spinal Elderly Orthosis: This orthosis is made of a dorsal, pelvic belt and ventricle. The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. The latest version of Spinal Elderly Orthosis is produced by the Iranian company Savad Teb. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic) . It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic) , which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the second 3next 9 months, and will be followed up by phone every month.
گروه مداخله: 'ارتوز سالمندی ستون فقرات به علاوه ورزش درمانی (Back School) ارتوز سالمندی ستون فقرات: این ارتوز از یک بخش پشتی، کمربند لگنی و ولکرو ساخته شده است. بخش اصلی ایجاد کننده فشار بر روی ستون مهرهها بخش پشتی میباشد که جنس آن فلزی است و پوششی نرم این بخش را میپوشاند. آخرین نسخه تهیه شده از ارتوز سالمندی ستون فقرات در شرکت ایرانی سواد طب درمان تولید میشود. در جلسه اول توسط ارتوزیست ارتوز سالمندی ستون فقرات متناسب با جثه افراد تجویز و نحوه استفاده از آن به افراد آموزش داده میشود تا روزانه 2 ساعت به مدت 6 ماه از ارتوز استفاده کنند. در مراجعات 3 ماهه اول هر دو هفته یکبار ارتوز تنظیم مجدد و پیشرفت داده میشود. ورزش درمانی Back School Program. روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار در این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 3 ماهه دوم به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد
گروه مداخله: 'ارتوز سالمندی ستون فقرات به علاوه ورزش درمانی (Back School) ارتوز سالمندی ستون فقرات: این ارتوز از یک بخش پشتی، کمربند لگنی و ولکرو ساخته شده است. بخش اصلی ایجاد کننده فشار بر روی ستون مهرهها بخش پشتی میباشد که جنس آن فلزی است و پوششی نرم این بخش را میپوشاند. آخرین نسخه تهیه شده از ارتوز سالمندی ستون فقرات در شرکت ایرانی سواد طب درمان تولید میشود. در جلسه اول توسط ارتوزیست ارتوز سالمندی ستون فقرات متناسب با جثه افراد تجویز و نحوه استفاده از آن به افراد آموزش داده میشود تا روزانه 2 ساعت به مدت 6 ماه ( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) از ارتوز استفاده کنند. در مراجعات 3 ماهه اول هر دو هفته یکبار ارتوز تنظیم مجدد و پیشرفت داده میشود. ورزش درمانی Back School Program. روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار در این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 9 ماهه بعدی به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد
گروه مداخله: 'ارتوز سالمندی ستون فقرات به علاوه ورزش درمانی (Back School) ارتوز سالمندی ستون فقرات: این ارتوز از یک بخش پشتی، کمربند لگنی و ولکرو ساخته شده است. بخش اصلی ایجاد کننده فشار بر روی ستون مهرهها بخش پشتی میباشد که جنس آن فلزی است و پوششی نرم این بخش را میپوشاند. آخرین نسخه تهیه شده از ارتوز سالمندی ستون فقرات در شرکت ایرانی سواد طب درمان تولید میشود. در جلسه اول توسط ارتوزیست ارتوز سالمندی ستون فقرات متناسب با جثه افراد تجویز و نحوه استفاده از آن به افراد آموزش داده میشود تا روزانه 2 ساعت به مدت 6 ماه ( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) از ارتوز استفاده کنند. در مراجعات 3 ماهه اول هر دو هفته یکبار ارتوز تنظیم مجدد و پیشرفت داده میشود. ورزش درمانی Back School Program. روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار در این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 39 ماهه دومبعدی به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد
#3
Control group: Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed.The exercises will be performed for 6 months, which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the second 3 months, and will be followed up by phone every month.
Control group: Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed.The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month.
Control group: Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed.The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the second 3next 9 months, and will be followed up by phone every month.
گروه کنترل: ورزش درمانی Back School Program. روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار در این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 3 ماهه دوم به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد
گروه کنترل: ورزش درمانی Back School Program. روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار در این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 9 ماهه بعدی به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد
گروه کنترل: ورزش درمانی Back School Program. روشی است که شامل برنامه آموزشی و مهارت آموزی میشود و تمرینات فیزیکی بخشی از این پروتکل درمانی است. گروههای 5 نفره بیماران دعوت به شرکت در مطالعه شده ، در جلسه اول توضیحات کلی مطالعه و اثر مداخله ورزش تفصیل داده خواهد شد. سپس تمرینات ورزشی بر اساس توانایی به افراد آموزش داده خواهد شد. شدت، مدت، تکرار به صورت فردی تنظیم شده و بیماران به انجام منظم روزانه ورزشها در دو هفته پیش رو توصیه می شوند.همچنین در مراجعات هر دو هفته یکبار در این گروهها با حضور متخصص پزشکی ورزشی تجربه و مشکلات خود را در میان خواهند گذاشت. این ورزشها شامل ورزشهای تقویت عضلات ناحیه کمر و شکم ، اندام فوقانی و تحتانی ، و اصلاحی وضعیت ستون فقرات می باشند. این ورزش ها در قالب دفترچه راهنما شامل شکل و توضیحات و لاگبوک جهت ثبت روزانه ورزشهای انجام شده به بیماران داده میشود. ورزش ها به مدت 6 ماه( که به علت پاندمی کووید 19 به یک سال افزایش پیدا کرد) انجام خواهد شد که در 3 ماهه اول دو هفته یکبار مراجعه خواهند داشت و در 39 ماهه دومبعدی به بیمارستان مراجعه نخواهند داشت و ماهانه به صورت تلفنی پیگیری خواهند شد
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: سید عباس متولیان
Full name of responsible person - Persian: Seyed Abbas Motevalian
Street address - English: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
Street address - Persian: Iran University of Medical Sciences,next to Milad Tower, Shahid Hemmat Highway
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 1021
Fax:
Email: motevalian.a@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Abbas Motevalian
Full name of responsible person - Persian: سید عباس متولیان
Street address - English: Iran University of Medical Sciences,next to Milad Tower, Shahid Hemmat Highway
Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8670 1021
Fax:
Email: motevalian.a@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: سید عباس متولیانSeyed Abbas Motevalian Full name of responsible person - Persian: Seyed Abbas Motevalianسید عباس متولیان Street address - English: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران Street address - Persian: Iran University of Medical Sciences,next to Milad Tower, Shahid Hemmat Highway Street address - Persian: بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 8670 1021 Fax: Email: motevalian.a@iums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the Effect of Spinomed and Elderly Orthoses plus Back School Program and Back School Program on Physical Fitness and Respiratory Capacity of Elderly with Thoracic Kyphosis
Design
A randomized, controlled, Two arm parallel group, single-blinded trial. Randomisation will be done by
random digits table and 60 patient will be devided randomly to Three groups of 20 each.
Settings and conduct
Location of research: Hazrate Rasoole Akram Hospital ; Sports Medicine Department ;
Patients have been blinded to other groups of study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 60 years or older;Kyphosis angle 50 degrees or more ;Ability to sit and stand up and walk at least 10 meters independently
Non-inclusion criteria:
Physical abnormalities other than kyphosis which may need treatment prior to research or impair the research process ; People who had a history of fracture or surgery in the lower extremity or spine 12 months before the begining of the research ; Any illness or disorder that disables one's participation in exercises and group activities
Intervention groups
Intervention Group 1: Spinomed Orthosis plus Back School Program
Will use orthosis and exercises for 12 weeks and they will come to hospital every 2 weeks to check and improve exercises and orthoses. Then will use orthosis and exercises for 12 weeks at home.
Intervention Group 2: Elderly Orthosis plus Back School Program
Will use Elderly orthosis and exercises for 12 weeks and they will come to hospital every 2 weeks to check and improve exercises and orthoses. Then will use orthosis and exercises for 12 weeks at home.
Control Group: Back School Program Exercises
Will use exercises for 12 weeks and they will come to hospital every 2 weeks to check and improve exercises. Then will use exercises for 12 weeks at home.
Main outcome variables
Physical Fitness and Respiratory Capacity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100623004251N13
Registration date:2020-04-04, 1399/01/16
Registration timing:registered_while_recruiting
Last update:2020-10-09, 1399/07/18
Update count:1
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Haleh Dadgostar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 4050
Email address
halehd@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Types of Orthosis and Back School Program on Physical Fitness and Respiratory Capacity of Elderly with Thoracic Kyphosis
Public title
Comparison of the Effect of Types of Orthosis and Back School Program on Physical Fitness and Respiratory Capacity of Elderly with Thoracic Kyphosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years or older
Kyphosis angle 50 degrees or more
Ability to sit and stand up and walk at least 10 meters independently
Exclusion criteria:
Physical abnormalities other than kyphosis which may need treatment prior to research or impair the research process
People who had a history of fracture or surgery in the lower extremity or spine 12 months before the begining of the research
Any illness or disorder that disables one's participation in exercises and group activities
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Iran University of Medical Sciences
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
تهران
Province
Tehran
Postal code
1445613131
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.IUMS.FMD.REC.1398.311
Health conditions studied
1
Description of health condition studied
Thoracic region postural Kyphosis
ICD-10 code
M40.04
ICD-10 code description
Postural kyphosis, thoracic region
Primary outcomes
1
Description
Physical Fitness consist of muscle strength, mucsle endurance and balance
Timepoint
At the begining of the study, after 12 weeks and one year ( At the begining the duration of the follow up was 6 months but after covid 19 pandemic, sampling was incomplete and the time of final assessment was changed from 6 month to one year. According to ethnic principles and to avoid endangering patients to come to Rasool Akram Hospital, which is the center of Corona, final assessments were performed by video call at home and inevitably, unmeasurable variables at home were eliminated in the final evaluation.)
Method of measurement
Muscle Strength by Dynamometer & Weight Machine, Muscle Endurance by 6 MWT( 6 minute walk test), Balance by Berg Balance Scale. Senior Fitness Test to Strength, Flexibility, Agility, Cardiopulmonary Fitness, Dynamic Balance
2
Description
Respiratory Capacity
Timepoint
At the begining of the study , after 12 weeks (Inevitably final assessment was eliminated due to covid 19 pandemic)
Method of measurement
Spirometry
Secondary outcomes
1
Description
Kyphosis Angle
Timepoint
At the begining of the study , after 12 weeks
Method of measurement
Inclinometer Device and X-ray (X-ray only at the begining and one year)
Intervention groups
1
Description
Intervention group 1: Spinomed Orthosis plus Back School Program Exercise Therapy: The spinomode orthosis is made of a dorsal, pelvic belt and ventricle.The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. This orthosis is adjustable and can be used for different sizes. The latest version of Spinomed Orthosis is available in various sizes from the German Medi Company. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic). It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month.
Category
Treatment - Devices
2
Description
Intervention group 2: Elderly Orthosis plus Back School Program Exercise Therapy Spinal Elderly Orthosis: This orthosis is made of a dorsal, pelvic belt and ventricle. The main part of the pressure on the spine is the back part, which is made of metal with a soft cover. The latest version of Spinal Elderly Orthosis is produced by the Iranian company Savad Teb. In the first session, the orthosist will prescribe orthosis according to patients body sizes to use it 2 hours daily for 6 months (which was increased to one year according to the covid 19 pandemic) . It will be re-adjusted and improved once every two weeks in first 3 months period. Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed. The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic) , which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month.
Category
Treatment - Devices
3
Description
Control group: Back School Exercise Therapy .It is a method that includes a training program and a physical exercise that is part of this treatment protocol. Groups of 5 patients will invite to participate in the study, the first session will provide a general description of the study and the effect of the exercise intervention. Exercises will then be taught to individuals based on their ability. The intensity, duration, repetition are individually adjusted and patients are advised to exercise regularly daily for the next two week. They will also share their experiences and problems in groups to a sports medicine specialist once every two weeks. These exercises include back and abdominal muscles , upper and lower limbs strengthening exercises ,and spinal posture correction. These exercises are given to patients in the form containing picture and description of exercises and a logbook for daily recording of the exercises performed.The exercises will be performed for 6 months (which was increased to one year according to the covid 19 pandemic), which will be performed once every two weeks in the first 3 months, and will not come to the hospital in the next 9 months, and will be followed up by phone every month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram Hospital
Full name of responsible person
Haleh Dadgostar
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 7308
Email
dadgostar.h@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences,next to Milad Tower, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 1021
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgostar
Position
Associate professor , Iran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 7308
Email
dadgostar.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haleh Dadgostar
Position
Associate professor , Iran University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
098 21 66537308
Email
dadgostar.h@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samane Ataei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Building No. 1, Hazrate Rasoole Akram Hospital, Niayesh Ave, Sattarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6653 7308
Email
samane_ataie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Changes in physical fitness after the intervention in the three study groups and compared to each other
Changes in muscle strenght after the intervention in the three study groups and compared to each other
Changes in endurance performance after the intervention in the three study groups and compared to each other
Changes in balance status after the intervention in the three study groups and compared to each other
Changes in respiratory capacity after the intervention in the three study groups and compared to each other
When the data will become available and for how long
Start of access to data 6 months after publishing the article
To whom data/document is available
Researchers working in academic institutions that want to use these findings in systematic reviews and meta analysis.
Under which criteria data/document could be used
Due to the presence of authors at accademic center, it's nessecary to obtain college written permission for sending data. Therefore, data will be sent no later than 6 months after requesting college written permission.
From where data/document is obtainable
Rasoul Akram Hospital , department of Sports Medicine
Dr Haleh dadgostar, Dr Samaneh ataie
What processes are involved for a request to access data/document
Information about who will review requests and criteria for reviewing requests may also be provided.