- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399823
The Effect of Taping in Addition to Self-stretching Exercise in the Elderly People With Hyperkyphosis
The Effect of Taping in Addition to Self-stretching Exercise on Thoracic Kyphosis Angle, Neck Pain and Quality of Life in Elderly People With Hyperkyphosis
Aim: The aim of the study is to investigate the effectiveness of kinesio taping and sham taping in addition to self-stretching exercise on hyperkyphosis angle, neck pain and quality of life in elderly individuals with hyperkyphosis.
Method: 60 elderly individuals with hyperkyphosis aged 60-85 years will be included in the study. Subjects will be divided inti three groups. Kinesio taping, sham taping and self-stretching exercise. The kinesio taping group will be given kinesio taping in addition to self stretching exercises. The second sham taping group will be given sham kinesio taping in addition to self stretching exercises. The third self-stretching group will be given a program consisting of stretching exercises for pectoral, erector spinae, latismus dorsi, multifidus, rhomboid and trapezius muscles. Individuals will be asked to do these exercises on their own for 15-20 minutes at home or in the office every day for four weeks. Before and after the study, the subjects will be test for the kyphosis angle will be evaluated with a flexible ruler and Scoliosis Research Society Outcome questionnaire (SRS22) will be used to evaluate spinal curvatures.The Neck Disability Questionnaire will be used to evaluate neck pain. The occiput-neck distance and mini mental test will be used in this srudy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Famagusta, Cyprus, 99628
- Eastern Mediterranean University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteer female and male individuals between the aged of 60-85 years,
- Kyphosis angle is greater than 56 degrees in women and 62 degrees in men,
- Individuals who have not physiotherapy in the last 6 months,
- Individuals who have not phsical activity in the last 6 months.
Exclusion Criteria:
- Individuals with any thoracic scoliosis and Scheuermann's disease,
- Individuals who having a kinesio tape allergy or developing an allergy while working.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self Stretching and Kinesio Taping Group
Kinesio taping in addition to self stretching exercises will be given for 15-20 minutes at home or in the office every day for four weeks.
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Strecthing exercises will given for 15-20 minutes everyday for four weeks
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Sham Comparator: Self Stretching and Sham Taping Group
Sham kinesio taping in addition to self stretching exercises will be given for 15-20 minutes at home or in the office every day for four weeks.
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Strecthing exercises will given for 15-20 minutes everyday for four weeks
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Active Comparator: Self Stretching Group
A program consisting of stretching exercises for pectoral, erector spinae, latismus dorsi, multifidus, rhomboid and trapezius muscles will be given for 15-20 minutes at home or in the office every day for four weeks.
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Strecthing exercises will given for 15-20 minutes everyday for four weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the kyphosis angle to be evaluated by a flexible ruler
Time Frame: Baseline and at the end of 4 weeks
|
C7 and T12 vertebrae will be taken as reference in the measurement of the kyphosis angle.
The Q angle is calculated by measuring the distances between the points taken as criteria.
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Baseline and at the end of 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chane in the spinal curvature to be evaluated by Scoliosis Research Society Outcome Questionnaire (SRS22)
Time Frame: Baseline and at the end of 4 weeks
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The SRS-22 scale is a scale developed by the Scoliosis Research Society to evaluate all spinal curvatures.
The scale consists of 22 questions and five subgroups.
Subgroups; pain, body image, spine functions, mental health and satisfaction with treatment.
Scores are calculated by assigning an answer value to all 22 questions within a five-point indicator chart.
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Baseline and at the end of 4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the level of neck pain and neck dysfunction to be evaluated by Neck Disability Questionnaire
Time Frame: Baseline and at the end of 4 weeks
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It is a patient-filled, condition-specific functional status questionnaire consisting of 10 items including pain, self-care, lifting, reading, headache, concentration, work, driving, sleep, and recreation.
Each section is scored on a scoring scale from 0 to 5; where zero means 'No Pain' and 5 means 'Worst pain imaginable'.
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Baseline and at the end of 4 weeks
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Change in the level of neck disability to be evaluated by Occiput-Wall Distance test
Time Frame: Baseline and at the end of 4 weeks
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For the measurement of occiput-wall distance, the patient stands in a standing position with his back to the wall with his hips and knees as straight as possible and tries to touch his head to the wall as much as possible in a neutral position.
At this time, the occiput wall distance is measured in cm.
The test is repeated 3 times and the mean distance is used to divide the participants into 3 groups according to the severity of kyphosis, including mild (≤5.0 cm), moderate (5.1-8.0 cm), and severe (> 8.0 cm).
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Baseline and at the end of 4 weeks
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Cognitive level of the subjects to be evaluated by Standardized Mini Mental Test
Time Frame: Baseline
|
Different cognitive abilities such as orientation, long and short term memory, attention, calculation, motor function and perception, remembering, language, and visuospatial abilities are used between 24-30 points normal, 18-23 points mild dementia, 17 points and below severe dementia it is compatible.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Inci Yuksek, Eastern Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/0111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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