Adolescent Idiopathic Scoliosis, Thoracic RegionNCT05723952
Effect of Barcelona School and Schroth for Adolescent Idiopathic Scoliosis.
A study testing Barcelona scoliosis physical therapy school and International scoliosis schroth therapy in people with Adolescent Idiopathic Scoliosis, Thoracic Region, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
for adolescent idiopathic scoliosis child, investigator will use Barcelona scoliosis physical therapy school and International scoliosis schroth therapy to see which school is better in dealing with scoliosis. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Thoracic Region
- What is being tested?
- Barcelona scoliosis physical therapy school and International scoliosis schroth therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 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
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- scoliosis with angle < 25 participant has Risser sign of П-V participant is not receiving other treatment during study participant not using braces or muscle relaxants
Who cannot join
- scoliosis due to congenital, neuro-muscular, or syndromic etiology, participant who has true leg length discrepancy participant who has cardiac anomalies participant who has kyphosis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Physical Therapy
Kafr ash Shaykh, Kafrelsheikh
eman m sherf eldin, DPT, 01005870085, eman_pg05@pt.kfs.edu.eg
About this study
Official title: Effect of Barcelona Scoliosis Physical Therapy Versus International Scoliosis Schroth Therapy in Adolescent Idiopathic Scoliosis
for adolescent idiopathic scoliosis child, investigator will use Barcelona scoliosis physical therapy school and International scoliosis schroth therapy to see which school is better in dealing with scoliosis.
- Being tested
- Barcelona scoliosis physical therapy school, International scoliosis schroth therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barcelona scoliosis physical therapy schoolOther
procedure for treating Adolescent Idiopathic scoliosis
International scoliosis schroth therapyOther
procedure for treating Adolescent Idiopathic scoliosis
| Study group | Role | What they receive |
|---|---|---|
| Barcelona scoliosis physical therapy school | Experimental | procedure for treating scoliosis Receives: Other: Barcelona scoliosis physical therapy school |
| International scoliosis schroth therapy | Experimental | procedure for treating scoliosis Receives: Other: International scoliosis schroth therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb's Angle
to determine angle of scoliosis
Measured: 3 month
Angle Trunk Rotation (ATR):
to determine amount of hump
Measured: 3 month
Secondary outcomes (1)
SRS-22 patient questionnaire
questionnaire to evaluate pain for spinal deformity patient
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis, Thoracic RegionStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mahmoud sherf eldin, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723952
- Sponsor's protocol ID
- EG,KFS lab research
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: share the result of the study not any personal information about patient
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Barcelona Scoliosis Physical Therapy Versus International Scoliosis Schroth Therapy in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05723952
- Acronym / sponsor ID
- EG,KFS lab research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 13 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.
for adolescent idiopathic scoliosis child, investigator will use Barcelona scoliosis physical therapy school and International scoliosis schroth therapy to see which school is better in dealing with scoliosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barcelona scoliosis physical therapy school | Experimental | Other: Barcelona scoliosis physical therapy schoolprocedure for treating scoliosis |
| International scoliosis schroth therapy | Experimental | Other: International scoliosis schroth therapyprocedure for treating scoliosis |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- scoliosis with angle < 25 participant has Risser sign of П-V participant is not receiving other treatment during study participant not using braces or muscle relaxants
Key exclusion criteria (1 listed)
- scoliosis due to congenital, neuro-muscular, or syndromic etiology, participant who has true leg length discrepancy participant who has cardiac anomalies participant who has kyphosis.
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 |
|---|---|---|
| Barcelona scoliosis physical therapy schoolprocedure for treating Adolescent Idiopathic scoliosis | Other | Barcelona scoliosis physical therapy school |
| International scoliosis schroth therapyprocedure for treating Adolescent Idiopathic scoliosis | Other | International scoliosis schroth therapy |
Primary outcome
Cobb's Angle
Time frame: 3 month
to determine angle of scoliosis
Angle Trunk Rotation (ATR):
Time frame: 3 month
to determine amount of hump
1 secondary outcome
SRS-22 patient questionnaire
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided. share the result of the study not any personal information about patient
Related trials for Adolescent Idiopathic Scoliosis, Thoracic Region
Not yet recruitingObservational study
Assessment of Respiratory Parameters, Aerobic Capacity and Sleep Quality in Thoracic AIS
Adolescent Idiopathic Scoliosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barcelona scoliosis physical therapy school and International scoliosis schroth therapy in people with Adolescent Idiopathic Scoliosis, Thoracic Region, run by Kafrelsheikh University 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 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eman m sherf eldin, DPT (01005870085, eman_pg05@pt.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb's Angle (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2023.