- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266637
Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics
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:
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.?
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahleya
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Gamasa, Dakahleya, Egypt, 7731168
- Delta University for Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
The experimental group will receive the same standard treatment in addition to Physiotherapeutic Scoliosis-Specific Exercise
|
Conventional Physical Therapy program: trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises
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
|
Active Comparator: Control group
The control group will receive the standard care composed of trunk muscles strengthening exercises, trunk proprioception exercises .
|
Conventional Physical Therapy program: trunk muscles strengthening exercises, trunk muscles endurance exercises, trunk proprioception exercises . postural correction exercises. Core exercise Spinal mobility exercises |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
From enrollment to the end of treatment at 6 months
|
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 )
|
From enrollment to the end of treatment at 6 months
|
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)
|
From enrollment to the end of treatment at 6 months
|
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)
|
From enrollment to the end of treatment at 6 months
|
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)
|
From enrollment to the end of treatment at 6 months
|
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).
|
From enrollment to the end of treatment at 6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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