Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization on the gait biomechanics of different preferential and high walking speeds as well as performance and quality of life in people with knee osteoarthritis
The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization on the gait biomechanics of different preferential and high walking speeds and sit to stand task as well as performance and quality of life in people with knee osteoarthritis
The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization on the gait biomechanics of different preferential and high walking speeds and sit to stand task as well as performance and quality of life in people with knee osteoarthritis
هدف از این مطالعه بررسی اثر موبیلیزیشن بافت نرم با ابزار بر بیومکانیک راه رفتن در سرعت های مختلف ترجیحی و بالای راه رفتن همچنین عملکرد و کیفیت زندگی افراد مبتلا به استئوآرتریت زانو است
هدف از این مطالعه بررسی اثر موبیلیزیشن بافت نرم با ابزار بر بیومکانیک راه رفتن در سرعت های مختلف ترجیحی و بالای راه رفتن و فعالیت ایستادن از وضعیت نشسته همچنین عملکرد و کیفیت زندگی افراد مبتلا به استئوآرتریت زانو است
هدف از این مطالعه بررسی اثر موبیلیزیشن بافت نرم با ابزار بر بیومکانیک راه رفتن در سرعت های مختلف ترجیحی و بالای راه رفتن و فعالیت ایستادن از وضعیت نشسته همچنین عملکرد و کیفیت زندگی افراد مبتلا به استئوآرتریت زانو است
Kinetic and kinematic variables of gait; pain; strength; Function; Range of motion
Kinetic and kinematic variables of gait and sit to stand task; pain; strength; Function; Range of motion
Kinetic and kinematic variables of gait and sit to stand task; pain; strength; Function; Range of motion
متغییرهای کینتیک و کینماتیک راه رفتن؛ درد؛ قدرت؛ عملکرد؛ دامنه حرکتی
متغییرهای کینتیک و کینماتیک راه رفتن و فعالیت ایستادن از وضعیت نشسته؛ درد؛ قدرت؛ عملکرد؛ دامنه حرکتی
متغییرهای کینتیک و کینماتیک راه رفتن و فعالیت ایستادن از وضعیت نشسته؛ درد؛ قدرت؛ عملکرد؛ دامنه حرکتی
General information
empty
Adding review of another functional activity
Adding review of another functional activity
empty
اضافه شدن بررسی یک فعالیت عملکردی دیگر
اضافه شدن بررسی یک فعالیت عملکردی دیگر
Effects of Instrument-Assisted Soft Tissue Release on Walking in Individuals with Knee Osteoarthritis
Effects of Instrument-Assisted Soft Tissue Release on Walking and Sit to Stand in Individuals with Knee Osteoarthritis
Effects of Instrument-Assisted Soft Tissue Release on Walking and Sit to Stand in Individuals with Knee Osteoarthritis
اثر آزاد سازی بافت نرم با ابزار بر راه رفتن افراد مبتلا به استئوآرتریت زانو
اثر آزاد سازی بافت نرم با ابزار بر راه رفتن و فعالیت ایستادن از وضعیت نشسته افراد مبتلا به استئوآرتریت زانو
اثر آزاد سازی بافت نرم با ابزار بر راه رفتن و فعالیت ایستادن از وضعیت نشسته افراد مبتلا به استئوآرتریت زانو
Effect of Instrument-Assisted Soft Tissue Mobilization on Gait Biomechanics in Individuals with Knee Osteoarthritis
Effect of Instrument-Assisted Soft Tissue Mobilization on Gait and Sit to Stand Task Biomechanics in Individuals with Knee Osteoarthritis
Effect of Instrument-Assisted Soft Tissue Mobilization on Gait and Sit to Stand Task Biomechanics in Individuals with Knee Osteoarthritis
تاثیر موبیلیزیشن بافت نرم با ابزار بر بیومکانیک راه رفتن در افراد مبتلا به استئوآرتریت زانو
تاثیر موبیلیزیشن بافت نرم با ابزار بر بیومکانیک راه رفتن و فعالیت ایستادن از حالت نشسته در افراد مبتلا به استئوآرتریت زانو
تاثیر موبیلیزیشن بافت نرم با ابزار بر بیومکانیک راه رفتن و فعالیت ایستادن از حالت نشسته در افراد مبتلا به استئوآرتریت زانو
Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury
Candidate for knee replacement surgery
Any congenital disease of the lower extremities or lower back or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait
Joint injection in the last six months
The difference in the length of the lower limbs is more than one and a half centimeters
Medium to high intensity involvement of both knees
Genovarum with a knee angle greater than 10 degrees
A body mass index greater than 30
Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury
Candidate for knee replacement surgery
Any congenital disease of the lower extremities or lower back or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task
Joint injection in the last six months
The difference in the length of the lower limbs is more than one and a half centimeters
Medium to high intensity involvement of both knees
Genovarum with a knee angle greater than 10 degrees
A body mass index greater than 30
Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury Candidate for knee replacement surgery Any congenital disease of the lower extremities or lower back or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task Joint injection in the last six months The difference in the length of the lower limbs is more than one and a half centimeters Medium to high intensity involvement of both knees Genovarum with a knee angle greater than 10 degrees A body mass index greater than 30
داشتن پیشینه‌ای از شکستگی یا آسیب لیگامانی مفصل ران یا زانو در سمت درگیر که منجر به آسیب ماندگار شده باشد
کاندید جراحی تعویض مفصل زانو
هر گونه بیماری مادرزادی در اندام تحتانی یا کمر و یا هرگونه بیماری ارتوپدی، نورولوژی و یا روماتولوژی که سبب اختلال در راه رفتن نرمال فرد باشد
تزریق در مفصل در شش ماه گذشته
اختلاف طول اندام های تحتانی بیشتر از یک و نیم سانتی متر
درگیری هر دو زانو با شدت متوسط به بالا
ژنوواروم بیش از 10 درجه زانو
شاخص توده بدن بالاتر از 30
داشتن پیشینه‌ای از شکستگی یا آسیب لیگامانی مفصل ران یا زانو در سمت درگیر که منجر به آسیب ماندگار شده باشد
کاندید جراحی تعویض مفصل زانو
هر گونه بیماری مادرزادی در اندام تحتانی یا کمر و یا هرگونه بیماری ارتوپدی، نورولوژی و یا روماتولوژی که سبب اختلال در راه رفتن یا فعالیت ایستادن از وضعیت نشسته نرمال فرد باشد
تزریق در مفصل در شش ماه گذشته
اختلاف طول اندام های تحتانی بیشتر از یک و نیم سانتی متر
درگیری هر دو زانو با شدت متوسط به بالا
ژنوواروم بیش از 10 درجه زانو
شاخص توده بدن بالاتر از 30
داشتن پیشینه‌ای از شکستگی یا آسیب لیگامانی مفصل ران یا زانو در سمت درگیر که منجر به آسیب ماندگار شده باشد کاندید جراحی تعویض مفصل زانو هر گونه بیماری مادرزادی در اندام تحتانی یا کمر و یا هرگونه بیماری ارتوپدی، نورولوژی و یا روماتولوژی که سبب اختلال در راه رفتن یا فعالیت ایستادن از وضعیت نشسته نرمال فرد باشد تزریق در مفصل در شش ماه گذشته اختلاف طول اندام های تحتانی بیشتر از یک و نیم سانتی متر درگیری هر دو زانو با شدت متوسط به بالا ژنوواروم بیش از 10 درجه زانو شاخص توده بدن بالاتر از 30
Primary outcomes
#1
Gait kinematic and kinetic variables
Gait and sit to stand task kinematic and kinetic variables
Gait and sit to stand task kinematic and kinetic variables
متغییرهای کینماتیک و کینتیک راه رفتن
متغییرهای کینماتیک و کینتیک راه رفتن و فعالیت ایستادن از وضعیت نشسته
متغییرهای کینماتیک و کینتیک راه رفتن و فعالیت ایستادن از وضعیت نشسته
Recruitment centers
#1
Name of recruitment center - English: Research-therapeutic center of movement disordes, Department of physiotherapy, TMU
Name of recruitment center - Persian: مرکز تحقيقاتي- درماني اختلالات حركتي گروه فیزیوتراپی دانشگاه تربیت مدرس
Full name of responsible person - English: Sahar Boozari
Full name of responsible person - Persian: سحر بوذری
Street address - English: Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Street address - Persian: ایران، تهران، بزرگراه جلال آل احمد، پل نصر، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 5053
Fax: +98 21 8800 6544
Email: s.boozari@modares.ac.ir
Web page address: http://ptmodares.ir
Name of recruitment center - English: Research-therapeutic center of movement disordes, Tarbiat Modares University
Name of recruitment center - Persian: مرکز تحقيقاتي- درماني اختلالات حركتي، دانشگاه تربیت مدرس
Full name of responsible person - English: Sahar Boozari
Full name of responsible person - Persian: سحر بوذری
Street address - English: Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
Street address - Persian: ایران، تهران، بزرگراه جلال آل احمد، پل نصر، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 5053
Fax: +98 21 8800 6544
Email: s.boozari@modares.ac.ir
Web page address: http://ptmodares.ir
Name of recruitment center - English: Research-therapeutic center of movement disordes, Department of physiotherapy, TMUTarbiat Modares University Name of recruitment center - Persian: مرکز تحقيقاتي- درماني اختلالات حركتي گروه فیزیوتراپی، دانشگاه تربیت مدرس Full name of responsible person - English: Sahar Boozari Full name of responsible person - Persian: سحر بوذری Street address - English: Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran Street address - Persian: ایران، تهران، بزرگراه جلال آل احمد، پل نصر، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713116 Phone: +98 21 8288 5053 Fax: +98 21 8800 6544 Email: s.boozari@modares.ac.ir Web page address: http://ptmodares.ir
Protocol summary
Study aim
The aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization on the gait biomechanics of different preferential and high walking speeds and sit to stand task as well as performance and quality of life in people with knee osteoarthritis
Design
Clinical trial with control group, double-blind, randomized by block design, on 34 patients
Settings and conduct
The location of this intervention will be in the research therapeutic center of movement disorders, Department of physiotherapy, Tarbiat Modares University. After an introductory session, people will enter the intervention phase. Individuals will be randomly assigned to the treatment and placebo groups. Participants and outcome assessors are unaware of the allocation of study groups. The intervention will be performed in four sessions over two weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women and men with knee osteoarthritis, a positive Clark test, and two and three degrees of osteoarthritis, according to the kellgren Lawrence scale؛ Exclusion criteria: Having a history of hip or knee joint fracture or ligament injury on the affected side that resulted in permanent injury
Intervention groups
The intervention group will be treated with instrument-assisted soft tissue mobilization along with stretching and strengthening exercises, and the control group will receive the instrument as a placebo. The intervention will be performed for both groups in four sessions over two weeks
Main outcome variables
Kinetic and kinematic variables of gait and sit to stand task; pain; strength; Function; Range of motion
General information
Reason for update
Adding review of another functional activity
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049511N2
Registration date:2021-12-25, 1400/10/04
Registration timing:prospective
Last update:2023-01-09, 1401/10/19
Update count:1
Registration date
2021-12-25, 1400/10/04
Registrant information
Name
Sahar Boozari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5053
Email address
s.boozari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Instrument-Assisted Soft Tissue Mobilization on Gait and Sit to Stand Task Biomechanics in Individuals with Knee Osteoarthritis
Public title
Effects of Instrument-Assisted Soft Tissue Release on Walking and Sit to Stand in Individuals with Knee Osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women and men with osteoarthritis of the knee
Ability to walk without the use of assistive devices
Pain between three and six in one knee, according to the visual analogue scale
A positive clark test result
Grade two and three osteoarthritis, according to the Kellgren-Lawrence scale
Exclusion criteria:
Have a history of a hip or knee joint fracture or ligament injury on the affected side that has resulted in permanent injury
Candidate for knee replacement surgery
Any congenital disease of the lower extremities or lower back or any orthopedic, neurological, or rheumatic disease that interferes with a person's normal gait or sit to stand task
Joint injection in the last six months
The difference in the length of the lower limbs is more than one and a half centimeters
Medium to high intensity involvement of both knees
Genovarum with a knee angle greater than 10 degrees
A body mass index greater than 30
Age
From 45 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into two groups: treatment and placebo. In this way, four blocks are identified, of which two blocks belong to the placebo group and two blocks belong to the treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are unaware of the allocation of study groups. The treatment in the two groups is quite similar, and the only difference in the use of tools in the placebo group is that they are exactly the same instruments used in the treatment group, but the intensity of pressure and the type of movement of the tool are different. The intensity of pressure and type of movement are two subjects that patients do not have and will not notice if they are in the placebo or treatment group. The outcome assessor is also unaware of the grouping of individuals.
Placebo
Used
Assignment
Parallel
Other design features
People are randomly divided into two groups. The intervention group receives the instrument along with exercise therapy. The control group will receive the instrument as a placebo along with exercise therapy
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2021-10-23, 1400/08/01
Ethics committee reference number
IR.MODARES.REC.1400.202
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Gait and sit to stand task kinematic and kinetic variables
Timepoint
Before and after the Intervention
Method of measurement
Inverse dynamics and force plate
2
Description
Pain
Timepoint
Before and after the Intervention
Method of measurement
Visual analogue scale
3
Description
Strength
Timepoint
Before and after the Intervention
Method of measurement
Dynamometer
4
Description
Musculoskelatal performance
Timepoint
Before and after the Intervention
Method of measurement
Functional tests
5
Description
Range of motion
Timepoint
Before and after the Intervention
Method of measurement
Goniameter
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and after the Intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: A series of lightweight steel instruments are gently applied to the muscles around the knee. The movement of the instrument in specific therapeutic directions is applied to the skin based on the initial assessment, and an emollient is used to move the instrument more easily. The treatment time with this tool is approximately five minutes. Then stretching and strengthening exercises are performed.
Category
Treatment - Other
2
Description
Control group: Steel instruments are gently applied to the muscles around the knee in this group. Using an emollient, the instrument is applied as a placebo with the least amount of pressure on the skin in all directions. The tool is moved on the patient's skin in different directions without considering the initial assessment. The direction and pressure applied by the instrument have no therapeutic properties. The treatment time is approximately five minutes. Then stretching and strengthening exercises are performed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research-therapeutic center of movement disordes, Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaghoub Fathollahi
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8288 3101
Email
Res@modares.ac.ir
Web page address
https://res.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Zahra Karimi Soluklo
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5052
Fax
+98 21 8800 6544
Email
zahra_karimi@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway, Tehran, Iran