- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06730269
Face-to-Face Vs. Telerehabilitation for Thoracic Hyperkyphosis in Children: a Clinical Trial
December 11, 2024 updated by: Seda GÖZENER CANBÜLBÜL, Medipol University
Comparative Efficacy of Face-to-Face and Telerehabilitation Approaches in Managing Thoracic Hyperkyphosis Among 9-12-Year-Olds: a Randomized Clinical Trial
This study evaluates the effectiveness of face-to-face versus telerehabilitation programs for children aged 9-12 with thoracic hyperkyphosis, a condition caused by poor posture that leads to excessive forward curvature of the spine.
Twenty children participated in a six-week corrective exercise program, either in person or through an online platform.
Both approaches significantly improved spinal posture, back muscle strength, and pain levels, with no notable differences in outcomes between the two methods.
The findings suggest that telerehabilitation is as effective as face-to-face rehabilitation, offering a flexible option for managing thoracic hyperkyphosis in children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kavacık
-
İstanbul, Kavacık, Turkey
- Istanbul Medipol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Children aged 9-12 years.
- Diagnosed with thoracic hyperkyphosis (Thoracic Kyphosis Angle > 40 degrees).
- Able to participate in a 6-week rehabilitation program (face-to-face or telerehabilitation).
Exclusion Criteria:
- Children with congenital spinal malformations.
- Children with mental health issues that could interfere with participation or compliance in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Face-to-Face Rehabilitation Group
Participants in this arm received a thoracic corrective exercise program in person, consisting of four exercises targeting back extensor muscles.
The exercises were performed three times a week for six weeks under the supervision of a trained therapist.
|
The Face-to-Face Rehabilitation Program is a structured rehabilitation regimen designed to improve posture, reduce pain, and strengthen back extensor muscles in children with thoracic hyperkyphosis.
Participants in this group engaged in the Thoracic Corrective Exercise Program, which included four specific exercises targeting thoracic spine correction.
The exercises were performed three times per week over six weeks, under the direct supervision of a trained therapist.
This setup ensured real-time feedback, personalized adjustments, and guidance during each session, optimizing the effectiveness of the rehabilitation process.
|
|
Experimental: Telerehabilitation Group
Participants in this arm followed the same thoracic corrective exercise program, but the sessions were delivered online through the Fiziu platform.
Exercises were performed three times a week for six weeks with remote guidance and monitoring.
|
The Telerehabilitation Program is a structured rehabilitation regimen designed to improve posture, reduce pain, and strengthen back extensor muscles in children with thoracic hyperkyphosis.
Participants in this group followed the Thoracic Corrective Exercise Program, which included four specific exercises targeting thoracic spine correction, performed three times per week over six weeks.
The program was delivered remotely through the Fiziu platform, allowing therapists to provide virtual guidance, feedback, and monitoring during the sessions.
This approach offered flexibility for families and ensured accessibility to rehabilitation services from the comfort of their homes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoracic Kyphosis Angle (TKA)
Time Frame: 6 weeks
|
It was measured using a flexicurve ruler to assess the curvature of the thoracic spine before and after the intervention. >45° is considered hyperkyphosis |
6 weeks
|
|
Manual Muscle Test (MMT)
Time Frame: 6 weeks
|
Evaluates back muscle strength before and after the intervention.
Minimum = 0 (no muscle contraction), Maximum = 5 (normal muscle strength).
|
6 weeks
|
|
Visual Analog Scale (VAS)
Time Frame: 6 weeks
|
Assesses pain levels before and after the intervention.
Minimum = 0 (no pain), Maximum = 10 (worst possible pain)
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seda Gözener Canbülbül, Medipol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Feng Q, Wang M, Zhang Y, Zhou Y. The effect of a corrective functional exercise program on postural thoracic kyphosis in teenagers: a randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):48-56. doi: 10.1177/0269215517714591. Epub 2017 Jun 14.
- Yang L, Lu X, Yan B, Huang Y. Prevalence of Incorrect Posture among Children and Adolescents: Finding from a Large Population-Based Study in China. iScience. 2020 May 22;23(5):101043. doi: 10.1016/j.isci.2020.101043. Epub 2020 Apr 8.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
December 2, 2023
Study Registration Dates
First Submitted
December 6, 2024
First Submitted That Met QC Criteria
December 11, 2024
First Posted (Estimated)
December 12, 2024
Study Record Updates
Last Update Posted (Estimated)
December 12, 2024
Last Update Submitted That Met QC Criteria
December 11, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- İMU-SEDAGOZENER-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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