NCT06730269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

1 month

First QC Date

December 6, 2024

Last Update Submit

December 11, 2024

Conditions

Keywords

Thoracic hyperkyphosisface-to-face rehabilitationtelerehabilitationspinal posturemusculoskeletal healthcorrective exercisesPediatric Kyphosis

Outcome Measures

Primary Outcomes (3)

  • Thoracic Kyphosis Angle (TKA)

    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)

    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)

    Assesses pain levels before and after the intervention. Minimum = 0 (no pain), Maximum = 10 (worst possible pain)

    6 weeks

Study Arms (2)

Face-to-Face Rehabilitation Group

EXPERIMENTAL

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

Telerehabilitation Group

EXPERIMENTAL

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

Interventions

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.

Face-to-Face Rehabilitation Group

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.

Also known as: Fiziu Platform Video Based Exercise Group
Telerehabilitation Group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Children with congenital spinal malformations.
  • Children with mental health issues that could interfere with participation or compliance in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Kavacık, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32330860BACKGROUND
  • 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.

    PMID: 28610442BACKGROUND

Related Links

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Seda Gözener Canbülbül

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 12, 2024

Study Start

October 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 2, 2023

Last Updated

December 12, 2024

Record last verified: 2024-12

Locations