Back Muscle Function in Adolescents With Idiopathic Scoliosis
Primary Purpose
Scoliosis Idiopathic, Scoliosis; Adolescence
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional screening trial for Scoliosis Idiopathic
Eligibility Criteria
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,
Sites / Locations
- Haifa University, Department of PHysical TherapyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
scoliosis
Arm Description
adolescent age 10-15 with idiopathic scoliosis
Outcomes
Primary Outcome Measures
Back muscle thickness in centimeters
back muscles thickness will be measured in rest and contraction using ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05961228
Brief Title
Back Muscle Function in Adolescents With Idiopathic Scoliosis
Official Title
Back Muscle Function During Exercise With and Without Correction According to the "Schroth" Method in Adolescents With Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Haifa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The function and asymmetry of back muscles will be examined in different positions and with specific spinal corrections based on scoliosis pattern and according to the "Schroth method" in adolescents with idiopathic scoliosis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Scoliosis; Adolescence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
one group - adolescent with scoliosis. The function and asymmetry of back muscles will be examined in different positions and with specific spinal corrections based on scoliosis pattern and according to the "Schroth method" in the entire sample.
Masking
None (Open Label)
Masking Description
participants will not be aware of the "Schroth method" or the difference between the exercises
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
scoliosis
Arm Type
Other
Arm Description
adolescent age 10-15 with idiopathic scoliosis
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Three different posture with and without correction according to the "Schroth" method
Primary Outcome Measure Information:
Title
Back muscle thickness in centimeters
Description
back muscles thickness will be measured in rest and contraction using ultrasound
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gali Dar, Prof
Phone
972505662054
Email
galidar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Dar, Prof.
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haifa University, Department of PHysical Therapy
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Phone
972-50-5662054
Email
galidar@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
one year following the end of the trial
Learn more about this trial
Back Muscle Function in Adolescents With Idiopathic Scoliosis
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