Adolescent KyphosisNCT05732090
Effect of Diaphragmatic Myofascial Release on Thoracic Angle and Pulmonary Functions in Hyperkyphotic Adolescents
A study testing therapeutic exercise program and diaphragmatic myofascial release in people with Adolescent Kyphosis, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Adolescent kyphotic girls will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. Read more about this study
- Who is it for?
- Ages 12 to 15 years, women only
- Conditions the study is for
- Adolescent Kyphosis
- What is being tested?
- therapeutic exercise program and diaphragmatic myofascial release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2022to 30 May 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 12 to 15 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree.
- Age ranged from 12 to 15 years old.
- selected from preparatory and secondary schools.
Who cannot join
- free from any associated deformities other than the thoracic kyphotic deformity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Diaphragmatic Myofascial Release on Thoracic Curvature Angle and Pulmonary Functions in Hyperkyphotic Adolescents
Adolescent kyphotic girls will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. They will be assessed at baseline and after three successive months of interventions for the following outcomes: Cobb angle by x-ray and pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Read the detailed description
Adolescent kyphotic girls with an age range of 12-15 years old will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. Both groupss will receive intervention for three three successive months. They will be be assessed at baseline and after three three successive months of interventions for the following outcomes:
Primary outcome: Cobb angle by x-ray Secondary outcome: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
- Conditions
- Adolescent Kyphosis
- Being tested
- therapeutic exercise program, diaphragmatic myofascial release
- Medical subject headings
- Scheuermann Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercise programOther
therapeutic exercise program (3 sessions/week/two months).
diaphragmatic myofascial releaseOther
therapeutic exercise program in addition to diaphragmatic myofascial release (3 sessions/week/two months).
| Study group | Role | What they receive |
|---|---|---|
| Control group (A) | Experimental | The control group will receive a therapeutic exercise program (3 sessions per week for two months). Receives: Other: therapeutic exercise program |
| study Group (B) | Experimental | study group will received the same intervention in control group in addition to diaphragmatic myofascial release (3 sessions/week/two months). Receives: Other: therapeutic exercise program; Other: diaphragmatic myofascial release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Cobb angle by x-ray
Measured: Change from Cobb angle at 3 months
Secondary outcomes (1)
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume)
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Measured: Change from pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start25 Feb 2022
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent KyphosisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732090
- Sponsor's protocol ID
- diaphragm myofascial release
- Status last verified
- May 2024
- First submitted
- 6 Feb 2023
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elabd OM, Elsamahy SA, Abdelmutilibe SM, Mohammed AH, Ali F, Elabd AM. Effect of Adding Diaphragmatic Myofascial Release to Corrective Exercise on the Thoracic Curvature Angle and Pulmonary Function Testing in Hyperkyphotic Adolescent Girls: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Mar 1;104(3):203-209. doi: 10.1097/PHM.0000000000002622. Epub 2024 Sep 16.
PubMed 39331044
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragmatic Myofascial Release on Thoracic Curvature Angle and Pulmonary Functions in Hyperkyphotic Adolescents
- ClinicalTrials.gov ID
- NCT05732090
- Acronym / sponsor ID
- diaphragm myofascial release
- Conditions
- Adolescent Kyphosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 16 Feb 2023 (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.
Adolescent kyphotic girls will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. They will be assessed at baseline and after three successive months of interventions for the following outcomes: Cobb angle by x-ray and pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Detailed description
Adolescent kyphotic girls with an age range of 12-15 years old will participate in this study. They will be divided into two groups. Group A: The control group will receive a therapeutic exercise program. Group B: The study group will receive the same intervention as Group A in addition to diaphragmatic myofascial release. Both groupss will receive intervention for three three successive months. They will be be assessed at baseline and after three three successive months of interventions for the following outcomes:
Primary outcome: Cobb angle by x-ray Secondary outcome: pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) by computerized spirometer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (A) | Experimental | Other: therapeutic exercise programThe control group will receive a therapeutic exercise program (3 sessions per week for two months). |
| study Group (B) | Experimental | Other: therapeutic exercise program, Other: diaphragmatic myofascial releasestudy group will received the same intervention in control group in addition to diaphragmatic myofascial release (3 sessions/week/two months). |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescents girls with thoracic kyphosis with cobb angle ranged from 45 to 55 degree.
- Age ranged from 12 to 15 years old.
- selected from preparatory and secondary schools.
Key exclusion criteria (1 listed)
- free from any associated deformities other than the thoracic kyphotic deformity.
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 |
|---|---|---|
| therapeutic exercise programtherapeutic exercise program (3 sessions/week/two months). | Other | Control group (A), study Group (B) |
| diaphragmatic myofascial releasetherapeutic exercise program in addition to diaphragmatic myofascial release (3 sessions/week/two months). | Other | study Group (B) |
Primary outcome
Cobb angle
Time frame: Change from Cobb angle at 3 months
Cobb angle by x-ray
1 secondary outcome
pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume)
Time frame: Change from pulmonary functions (vital capacity, forced vital capacity and maximum ventilatory volume) at 2 months
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 22 May 2024.
- Derived from this study: PubMed 39331044Elabd OM, Elsamahy SA, Abdelmutilibe SM, Mohammed AH, Ali F, Elabd AM. Effect of Adding Diaphragmatic Myofascial Release to Corrective Exercise on the Thoracic Curvature Angle and Pulmonary Function Testing in Hyperkyphotic Adolescent Girls: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Mar 1;104(3):203-209. doi: 10.1097/PHM.0000000000002622. Epub 2024 Sep 16.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic exercise program and diaphragmatic myofascial release in people with Adolescent Kyphosis, run by Delta University for Science and Technology at 1 site in Egypt.
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 1 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 22 May 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 Egypt. 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?
Cobb angle (time frame: Change from Cobb angle at 3 months). 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 NCT05732090, which also lists 1 linked publication.
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 22 May 2024.