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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Face-to-Face Rehabilitation Program
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.
Behavioral: Telerehabilitation Program
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:
  • Fiziu Platform Video Based Exercise Group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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