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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05961228
Other study ID # 161/23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 10, 2023
Est. completion date July 2024

Study information

Verified date July 2023
Source University of Haifa
Contact Gali Dar, Prof
Phone 972505662054
Email galidar@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
exercise
Three different posture with and without correction according to the "Schroth" method

Locations

Country Name City State
Israel Haifa University, Department of PHysical Therapy Haifa

Sponsors (1)

Lead Sponsor Collaborator
University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Back muscle thickness in centimeters back muscles thickness will be measured in rest and contraction using ultrasound baseline
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