Protocol summary
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Study aim
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Determination of the effect of kinesiotype band on angular change in patients with postural kyphosis and comparison with control group
Determination of the degree of kyphosis according to demographic variables
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Design
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This study was a single blind randomized control trial on 33 patients with postural kyphosis. The participants were divided into three groups, which included the control group with routine therapies and the two groups of parallel with the different approaches attaching the kynesiotape band.
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Settings and conduct
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Target population: participants with postural kyphosis who are referred to the research center of Tabriz Imam Reza Hospital from clinic.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria in the study: patient Satisfaction to Participate in the Study, age between 15 and 20 years, natural neurological examination , angle 60> x> 40 degrees on sagittal plane. exclusion criteria: chest diseases, scoliosis, previous damage to the spine and pelvis and lower extremities, use of drugs that affect muscle function at least 3 months ago or during the study, presence of systemic or localized infection in the spine, tumor, disease Skin, asthma, epilepsy, uncompensated heart failure, disc disease, history of previous surgery, spinal anomalies.
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Intervention groups
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The control group: patients undergo routine and corrective exercises and intervention groups are treated with differential approach of kynesiotape that included the paper off method with elongation of 10-15%, with the goal of most of the role of supportive tape strip, reducing pain, muscle fatigue and light to moderate tension method with a tensile strength of 50-25%with the goal of the muscle stimulation to increase muscle strength and strength.
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Main outcome variables
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Measured angle;
General information
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Reason for update
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The age range in this study was changed from 13-18 year-old to 15-20 year-old when data was collected.
Cause:
In this study, to check and control the participants activities before and after entering the study, including variables affecting the postural kyphosis angle, such as sitting time and physical activity level, we used the International Physical Activity Questionnaire (IPAQ), however, this questionnaire was created and evaluated for the age range of 15-69 year-old, So we decided to change the starting age range from 13 to 15, and also, since the patients were referred by the clinic, due to the influenza and Covid-19 period at the time of data collection, and due to the shortage of referral participants . We had to increase the age range of participants from 18 to 20 at the study.In the title section, only the stretching forces/directions of the tape is entered.
secondary variable: physical activity level, sitting time (sedentary behavior)
We hope that due to the difficulties and conditions during data collection, you will apply the age change created in this study to IRCT.
sincerely
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091104002664N4
Registration date:
2019-07-07, 1398/04/16
Registration timing:
prospective
Last update:
2023-11-10, 1402/08/19
Update count:
2
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Registration date
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2019-07-07, 1398/04/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-12, 1398/04/21
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Expected recruitment end date
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2020-04-17, 1399/01/29
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Actual recruitment start date
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2019-07-12, 1398/04/21
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Actual recruitment end date
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2020-04-17, 1399/01/29
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Trial completion date
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2020-04-17, 1399/01/29
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Scientific title
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The Effect of A Combination of Corrective Exercise and Kinesio taping stretching forces/directions on Postural Kyphosis in Adolescents
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Public title
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Kinesio taping in Postural Kyphosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient Satisfaction to Participate in the Study
Age of entry between 15 and 20 years old
Natural neurological examination
Angle 40> x> 60 degrees on sagittal plane
Exclusion criteria:
Chest Diseases
Scoliosis
Previous injuries to the spine and pelvis and lower extremities
Taking medications that affect muscle function at least 3 months or during the study
Systemic or localized infection in the spine
Tumors and malignancies
Diseases of the skin such as psoriasis and eczema
Asthma
Epilepsy
Uncompensated heart failure
Diseases of the disc
History of previous spinal anomalies such as spondylosis, spondylolystitis, Schuermann's disease, congenital spinal cord disease
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Age
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From 15 years old to 20 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
33
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: Simple randomization
Random unit: Individual randomization
Randomization tool: Statistical software
The sequence of randomization : Randomized interventions will be assigned to patients in the order of entering the study.
Allocation concealment:
Non-transparent letter packets with random sequences will be used, so that first a random sequence will be generated by statistical software, then a number of envelopes with an aluminum wrapper will be provided and each random sequence created on a card And the cards are inserted into the envelopes of the letter, in order to preserve the random sequence on the outer surface of the envelopes, the numbering is done in the same order. Finally, the envelope is enclosed and placed in a box respectively. At the time of registration, participants will receive one of the envelopes in the order of entry, and the group assigned to that participant will be identified.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Blind group are participants who will be unaware of the allocation of treatment using sealed letter packets.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-08, 1397/10/18
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Ethics committee reference number
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IR.TBZMED.REC.1397.780
Health conditions studied
1
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Description of health condition studied
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Postural Kyphosis
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ICD-10 code
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M40.04
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ICD-10 code description
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Postural kyphosis, thoracic region
Primary outcomes
1
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Description
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Measured angle
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Timepoint
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Patients are evaluated before and after the visit, and one month after the change in postural kyphosis angle and motion limitation.
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Method of measurement
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Clinical examination, flexible ruler, kyofometry and photogrammetric
Secondary outcomes
1
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Description
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physical activity level
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Timepoint
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before intervention and 6 weeks after intervention
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Method of measurement
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IPAQ (International Physical Activity Questionnaire)
2
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Description
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sitting time (sedentary behavior)
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Timepoint
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before intervention and 6 weeks after intervention
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Method of measurement
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IPAQ (International Physical Activity Questionnaire)
Intervention groups
1
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Description
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Intervention group: The second group and the third group are interventional group that are treated with kynesiotape bandage along with routine treatments. intervention groups are treated with differential approach of kinesiopy strip tape so that in the first group of intervention, the paper off method is used, in which in this method, an elongation of 10-15% is used, with the goal of most of the role of supportive tape strip, reducing pain and thoracic and reducing muscle fatigue.
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Category
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Treatment - Other
2
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Description
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Intervention group: . In the second group, the method uses a light to moderate tension method with a tensile strength of 50-25%, in which the aim is to stimulate the muscle to increase muscle strength and strength.The shape of the binding band is in the form of V, and the patient is asked to sit in a sitting position. The therapist measures the strip band from the T1-T12 vertebrae and slices 4 pieces with it, and then, the band is bonded with the desired elasticity in the shape of V. The method of attaching the strip band is also such that a piece of striped band is parallel to the spine and is spaced 5 cm in place of the erector spine muscle. The second piece is fastened to form a larger sensor to facilitate the extension of the trunk and after 1 month to follow up and review the effect of the treatment. Patients are evaluated before and after the visit, and one month after the change in postural kyphosis angle and motion constraints.
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Category
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Treatment - Other
3
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Description
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Control group: : The control group is where patients undergo routine and corrective exercises.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available