Kyphosis ThoracicNCT06730269
Face-to-Face Vs. Telerehabilitation for Thoracic Hyperkyphosis in Children: a Clinical Trial
A study testing Face-to-Face Rehabilitation Program and Telerehabilitation Program in people with Kyphosis Thoracic and Hyperkyphosis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Kyphosis Thoracic, Hyperkyphosis
- What is being tested?
- Face-to-Face Rehabilitation Program and Telerehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Children with congenital spinal malformations.
- Children with mental health issues that could interfere with participation or compliance in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kyphosis Thoracic, Hyperkyphosis
- Being tested
- Face-to-Face Rehabilitation Program, Telerehabilitation Program
- Keywords
- Thoracic hyperkyphosis, face-to-face rehabilitation, telerehabilitation, spinal posture, musculoskeletal health, corrective exercises, Pediatric Kyphosis
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-Face Rehabilitation ProgramBehavioural
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.
Telerehabilitation ProgramBehavioural
Also called Fiziu Platform Video Based Exercise 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Telerehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 6 weeks
Visual Analog Scale (VAS)
Assesses pain levels before and after the intervention. Minimum = 0 (no pain), Maximum = 10 (worst possible pain)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Oct 2023
- Primary completion1 Nov 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kyphosis ThoracicStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda GÖZENER CANBÜLBÜL, Medipol University
- Investigators
- Seda Gözener Canbülbül, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730269
- Sponsor's protocol ID
- İMU-SEDAGOZENER-004
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32330860Feng 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.
PubMed 28610442
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Face-to-Face and Telerehabilitation Approaches in Managing Thoracic Hyperkyphosis Among 9-12-Year-Olds: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06730269
- Acronym / sponsor ID
- İMU-SEDAGOZENER-004
- Conditions
- Kyphosis Thoracic, Hyperkyphosis
- Keywords
- Thoracic hyperkyphosis, face-to-face rehabilitation, telerehabilitation, spinal posture, musculoskeletal health, corrective exercises, Pediatric Kyphosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face Rehabilitation Group | Experimental | Behavioral: Face-to-Face Rehabilitation ProgramParticipants 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. |
| Telerehabilitation Group | Experimental | Behavioral: Telerehabilitation ProgramParticipants 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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Children with congenital spinal malformations.
- Children with mental health issues that could interfere with participation or compliance in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-Face Rehabilitation ProgramThe 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. | Behavioural | Face-to-Face Rehabilitation Group |
| Telerehabilitation ProgramAlso: Fiziu Platform Video Based Exercise GroupThe 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. | Behavioural | Telerehabilitation Group |
Primary outcome
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
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).
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 32330860Yang 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.
- Background: PubMed 28610442Feng 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Kyphosis Thoracic
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
Recruiting
Kinesio Taping in Young Adults With Thoracic Hyperkyphosis
Thoracic Hyperkyphosis
RecruitingObservational study
Posture, Proprioception, Core Stability, and Balance in Weightlifters
Balance Assessment, Kyphosis Postural Thoracic
Recruiting
Effects of a Wearable Device ,Phone App and Exercise on Cervico-thoracic Posture in University Students.
Forward Head Posture
Active, not recruitingObservational study
Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study
Scoliosis, Kyphosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seda Gözener Canbülbül principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-Face Rehabilitation Program and Telerehabilitation Program in people with Kyphosis Thoracic and Hyperkyphosis, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic Kyphosis Angle (TKA) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06730269, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.