NCT05399823

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

May 27, 2022

Last Update Submit

August 28, 2023

Conditions

Keywords

ExerciseKinesiotapeKyphosisElderly

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and at the end of 4 weeks

Secondary Outcomes (1)

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

    Baseline and at the end of 4 weeks

Other Outcomes (3)

  • Change in the level of neck pain and neck dysfunction to be evaluated by Neck Disability Questionnaire

    Baseline and at the end of 4 weeks

  • Change in the level of neck disability to be evaluated by Occiput-Wall Distance test

    Baseline and at the end of 4 weeks

  • Cognitive level of the subjects to be evaluated by Standardized Mini Mental Test

    Baseline

Study Arms (3)

Self Stretching and Kinesio Taping Group

EXPERIMENTAL

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.

Other: Exercise

Self Stretching and Sham Taping Group

SHAM COMPARATOR

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.

Other: Exercise

Self Stretching Group

ACTIVE COMPARATOR

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.

Other: Exercise

Interventions

Strecthing exercises will given for 15-20 minutes everyday for four weeks

Self Stretching GroupSelf Stretching and Kinesio Taping GroupSelf Stretching and Sham Taping Group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Individuals with any thoracic scoliosis and Scheuermann's disease,
  • Individuals who having a kinesio tape allergy or developing an allergy while working.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Motor ActivityKyphosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Inci Yuksek

    Eastern Mediterranean University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

January 14, 2022

Primary Completion

August 28, 2023

Study Completion

August 30, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations