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The Effect of Taping in Addition to Self-stretching Exercise in the Elderly People With Hyperkyphosis

Primary Purpose

Physical Performance

Status
Active
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Exercise
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Physical Performance focused on measuring Exercise, Kinesiotape, Kyphosis, Elderly

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eastern Mediterranean University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Self Stretching and Kinesio Taping Group

Self Stretching and Sham Taping Group

Self Stretching Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in the kyphosis angle to be evaluated by a flexible ruler
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.

Secondary Outcome Measures

Chane in the spinal curvature to be evaluated by Scoliosis Research Society Outcome Questionnaire (SRS22)
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.

Full Information

First Posted
May 27, 2022
Last Updated
August 28, 2023
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05399823
Brief Title
The Effect of Taping in Addition to Self-stretching Exercise in the Elderly People With Hyperkyphosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
August 28, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Performance
Keywords
Exercise, Kinesiotape, Kyphosis, Elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self Stretching and Kinesio Taping Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Self Stretching and Sham Taping Group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Self Stretching Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Strecthing exercises will given for 15-20 minutes everyday for four weeks
Primary Outcome Measure Information:
Title
Change in the kyphosis angle to be evaluated by a flexible ruler
Description
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.
Time Frame
Baseline and at the end of 4 weeks
Secondary Outcome Measure Information:
Title
Chane in the spinal curvature to be evaluated by Scoliosis Research Society Outcome Questionnaire (SRS22)
Description
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.
Time Frame
Baseline and at the end of 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in the level of neck pain and neck dysfunction to be evaluated by Neck Disability Questionnaire
Description
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'.
Time Frame
Baseline and at the end of 4 weeks
Title
Change in the level of neck disability to be evaluated by Occiput-Wall Distance test
Description
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).
Time Frame
Baseline and at the end of 4 weeks
Title
Cognitive level of the subjects to be evaluated by Standardized Mini Mental Test
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inci Yuksek
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99628
Country
Cyprus

12. IPD Sharing Statement

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The Effect of Taping in Addition to Self-stretching Exercise in the Elderly People With Hyperkyphosis

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