Scoliosis IdiopathicNCT06266637
Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics
A study testing Conventional Physical Therapy Program and Physiotherapeutic Scoliosis-Specific Exercise (Schroth) in people with Scoliosis Idiopathic, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial BACKGROUND: Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Conventional Physical Therapy Program and Physiotherapeutic Scoliosis-Specific Exercise (Schroth)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2023to 15 Mar 2024
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents with age 10-18 years
- complaining of dorsolumbar scoliosis
- curves (apex lies between D10 and L4)
- curve magnitudes greater than 15 degrees and less than 90
- using or not using brace
- all maturity levels (Risser = 0-5)
Who cannot join
- Other types of scoliosis ; congenital or neuromuscular
- Current physical therapy or medical treatment for scoliosis,
- Contracture or surgery affecting the lumbar spine or lower limbs
- Pathologies such as inflammatory diseases
- congenital anomalies
- Neurological disorders like cerebral palsy or ataxia
- dislocations
- visual or auditory problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Delta university for science and technology
Gamasa, Dakahlia Governorate, 7731168
About this study
Official title: Effect of Physiotherapeutic Scoliosis-Specific Exercise on Lower Limb Biomechanics in Adolescents With Idiopathic Scoliosis: A Randomised Controlled Trial
PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial
BACKGROUND:
Read more
Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.
HYPOTHESES:
Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.
RESEARCH QUESTION:
What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?
Read the detailed description
procedures: A randomized controlled clinical trial will be conducted
Assessment:
x-ray computed scanogram radiography of the whole spine and both lower limbs in standing will be used.
The following measurements will be taken pre and post the treatment program:
For the lumbar spine coronal alignment:
- Cobb's angle for dorso-lumbar scoliosis (curve apex from D10- L4) will be measured.
- Coronal balance estimated by the distance between plumb line and central sacral line from anterioposterior x-ray view
For both lower limbs:
- the length will be measured for the limb, the tibia and the femur
- tibiofemoral angle
- joint line convergence angle
- mechanical axis
- mechanical axis deviation
Treatment:
Patients will be randomly assigned into two groups to receive the prescribed treatment program for 6 months., 1 session per week in addition to a home program of daily exercise .
The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises .
The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise
Data will be analyzed using 2 way MANOVA.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Conventional Physical Therapy Program, Physiotherapeutic Scoliosis-Specific Exercise (Schroth)
- Keywords
- scoliosis, exercise, lower limb, biomechanics
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical Therapy ProgramOther
Conventional Physical Therapy program:
trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises
Physiotherapeutic Scoliosis-Specific Exercise (Schroth)Other
It uses exercises customized for each patient to return the curved spine to a more natural position. The spine is addressed in all three anatomical planes - sagittal, frontal and transverse. The purpose of the method is to create spinal balance and stability by improving body mechanics and spinal stabilization to prevent further curve progression
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise Receives: Other: Conventional Physical Therapy Program; Other: Physiotherapeutic Scoliosis-Specific Exercise (Schroth) |
| Control group | Active comparator | The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises . Receives: Other: Conventional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb's angle
Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)
Measured: From enrollment to the end of treatment at 6 months
Coronal balance
Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )
Measured: From enrollment to the end of treatment at 6 months
length of the the tibia and femur
The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)
Measured: From enrollment to the end of treatment at 6 months
tibiofemoral angle
The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
Measured: From enrollment to the end of treatment at 6 months
knee joint line convergence angle
The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
Measured: From enrollment to the end of treatment at 6 months
lower limb mechanical axis; and mechanical axis deviation
The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start12 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Omar Mohamed Ali Elabd, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266637
- Sponsor's protocol ID
- P.T.REC/012/004999
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: personal preferences
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapeutic Scoliosis-Specific Exercise on Lower Limb Biomechanics in Adolescents With Idiopathic Scoliosis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06266637
- Acronym / sponsor ID
- P.T.REC/012/004999
- Conditions
- Scoliosis Idiopathic
- Keywords
- scoliosis, exercise, lower limb, biomechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 20 Feb 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.
PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial
BACKGROUND:
Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined.
HYPOTHESES:
Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.
RESEARCH QUESTION:
What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?
Detailed description
procedures: A randomized controlled clinical trial will be conducted
Assessment:
x-ray computed scanogram radiography of the whole spine and both lower limbs in standing will be used.
The following measurements will be taken pre and post the treatment program:
For the lumbar spine coronal alignment:
- Cobb's angle for dorso-lumbar scoliosis (curve apex from D10- L4) will be measured.
- Coronal balance estimated by the distance between plumb line and central sacral line from anterioposterior x-ray view
For both lower limbs:
- the length will be measured for the limb, the tibia and the femur
- tibiofemoral angle
- joint line convergence angle
- mechanical axis
- mechanical axis deviation
Treatment:
Patients will be randomly assigned into two groups to receive the prescribed treatment program for 6 months., 1 session per week in addition to a home program of daily exercise .
The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises .
The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise
Data will be analyzed using 2 way MANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Conventional Physical Therapy Program, Other: Physiotherapeutic Scoliosis-Specific Exercise (Schroth)The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise |
| Control group | Active comparator | Other: Conventional Physical Therapy ProgramThe control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises . |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Adolescents with age 10-18 years
- complaining of dorsolumbar scoliosis
- curves (apex lies between D10 and L4)
- curve magnitudes greater than 15 degrees and less than 90
- using or not using brace
Key exclusion criteria (8 listed)
- Other types of scoliosis ; congenital or neuromuscular
- Current physical therapy or medical treatment for scoliosis,
- Contracture or surgery affecting the lumbar spine or lower limbs
- Pathologies such as inflammatory diseases
- congenital anomalies
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 |
|---|---|---|
| Conventional Physical Therapy ProgramConventional Physical Therapy program: trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises | Other | Control group, Study group |
| Physiotherapeutic Scoliosis-Specific Exercise (Schroth)It uses exercises customized for each patient to return the curved spine to a more natural position. The spine is addressed in all three anatomical planes - sagittal, frontal and transverse. The purpose of the method is to create spinal balance and stability by improving body mechanics and spinal stabilization to prevent further curve progression | Other | Study group |
Primary outcome
Cobb's angle
Time frame: From enrollment to the end of treatment at 6 months
Cobb's angle for dorso-lumbar scoliosis. The angle of the curve apex from D10 to L4 will be assessed by computed radiograph (X-ray computed scanogram)
Coronal balance
Time frame: From enrollment to the end of treatment at 6 months
Coronal balance estimated by the distance between plumb line and central sacral line from Anetroposterior x-ray view assessed by computed radiograph (X-ray computed scanogram )
length of the the tibia and femur
Time frame: From enrollment to the end of treatment at 6 months
The length (in centimeter) of the Tibia and femur will be assessed by computed radiograph (X-ray computed scan-gram)
tibiofemoral angle
Time frame: From enrollment to the end of treatment at 6 months
The tibiofemoral angle (TFA), or knee angle, is defined as the angle between the anatomical axis of femur with the anatomical axis of tibia. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
knee joint line convergence angle
Time frame: From enrollment to the end of treatment at 6 months
The knee joint-line convergence angle (KJLCA) h is the angle made by a tangential line between the femoral condyles and the tibial plateau. It will be assessed (in degrees) by computed radiograph (X-ray computed scan-gram)
lower limb mechanical axis; and mechanical axis deviation
Time frame: From enrollment to the end of treatment at 6 months
The mechanical axis of the lower limb, also called the Mikulicz line, is drawn by connecting a point in the center of the femoral head to a point in the center of the ankle. The value of the deviation is measured in millimeters and is named mechanical axis deviation (MAD). It will be assessed by computed radiograph (X-ray computed scan-gram).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No. personal preferences
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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 Conventional Physical Therapy Program and Physiotherapeutic Scoliosis-Specific Exercise (Schroth) in people with Scoliosis Idiopathic, 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 6 inclusion and 8 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 20 Feb 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?
Results are not available in the source record.
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's angle (time frame: From enrollment to the end of treatment at 6 months). The study lists 6 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 20 Feb 2024.