- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05961228
Back Muscle Function in Adolescents With Idiopathic Scoliosis
Back Muscle Function During Exercise With and Without Correction According to the "Schroth" Method in Adolescents With Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study aim is to examine function and asymmetry of back muscles in different positions and with and without specific spinal corrections based on scoliosis pattern and according to "Schroth ethod" in adolescenet idiopathic scoliosis. The will include adolescents aged 10-14 years diagnosed on X-ray with idiopathic scoliosis of 15-400 Cobb angle. Participants will undergo an assessment that includes: demographic questionnaire, pain severity measured by the visual analog scale , quality of life questionnaire for patients with scoliosis (SRS-22), Adam's Forward Bend Test, spine rotation angle assessment using a scoliometer, leg length measurement, hip range of motion using goniometer, Risser sign, Coronal trunk balance and Sagittal vertical axis- according to X-ray, scoliosis classification.
Following examination, participants will perform three exercises that activate back muscles in three different positions: supine lying, side lying and standing. Each exercise will be performed twice: the first time without and the second time with specific corrections of the scoliosis. The exercises will be performed according to "Schroth" method implying that the corrections of the spine will be determined according to the scoliosis pattern and classification for the scoliosis (single / double, thoracic, lumbar etc.) and will be conducted via belts, cushions, and bars.
During each exercise, back muscles thickness will be examined and measured via portable diagnostic ultrasound. The muscles will be measured at T7 and L4 levels in resting and contracting positions. Back muscle function will be evaluated by calculating percentage of change between positions rest and contraction position.
Comparison between muscle function with and without correction and correlation of muscle function to quality of life and other morphological parameters will be assessed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Haifa University, Department of PHysical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents who have been diagnosed by X-ray with idiopathic scoliosis of 15-40°,
- Risser sign zero to four,
- have recent X-rays.
Exclusion Criteria:
- previous back surgery
- have been treated with physical therapy in the past year,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: scoliosis
adolescent age 10-15 with idiopathic scoliosis
|
Three different posture with and without correction according to the "Schroth" method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Back muscle thickness in centimeters
Time Frame: baseline
|
back muscles thickness will be measured in rest and contraction using ultrasound
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gali Dar, Prof., University of Haifa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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