Back to resultsSchroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
Primary Purpose
Idiopathic Spinal Deformities
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Schroth Exercise
Functional Electrical Stimulation (physiotherapy techniques)
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Spinal Deformities
Eligibility Criteria
Inclusion Criteria:
- Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles .
- All children are normal &perform all activities of daily living
- They were able to understand and follow verbal commands and instructions included in the testing procedures.
Exclusion Criteria:
- All of them could be part of recreational activities in their public schools but no competitive sports.
- Children who participated in any regular sport activities involving the lower extremities will be excluded.
- None of them had any surgical intervention .
- None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
- They had neither visual, auditory defect.
Sites / Locations
- Amira Hussin Mohammed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Schroth Exercise
Functional Electrical Stimulation
Arm Description
The Schroth Method is a nonsurgical option for scoliosis treatment. It uses exercises customized for each patient to return the curved spine to a more natural position. The goal of Schroth exercises is to de-rotate, elongate and stabilize the spine in a three-dimensional plane. it will be applied 3 session per week for 3 months.
30 minutes of Functional Electrical Stimulation (FES) three times a week for 3 months. Two electrodes were attached on the lateral parts of the convex side of the body, and two others on the erector spinae muscles. FES (CU-FS1; Novastim, Korea) was set at a frequency of 35 Hz, with a 250-μs pulse width. Electrical stimulation lasted for 6 seconds, followed by a 6-second rest.
Outcomes
Primary Outcome Measures
cobb angle
The measurement of Cobb angle involves estimating the angle between the two tangents of the upper and lower end-plates of the upper and lower end vertebra, respectively.
cobb angle
The measurement of Cobb angle involves estimating the angle between the two tangents of the upper and lower end-plates of the upper and lower end vertebra, respectively
Secondary Outcome Measures
Full Information
NCT ID
NCT05090436
First Posted
September 17, 2021
Last Updated
March 10, 2023
Sponsor
Delta University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05090436
Brief Title
Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
Official Title
Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Abnormal spinal curvature can occur as a result of neurologic, orthopedic or idiopathic factors. The role of physiotherapy is not only to prevent intrinsic changes that may occur in the spine but also be used to correct postural abnormalities. this study will investigate the impact of Schroth Exercise compared to Functional Electrical Stimulation in Adolescent With Spinal Deformities (scoliosis and or kyphosis).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Spinal Deformities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Schroth Exercise
Arm Type
Experimental
Arm Description
The Schroth Method is a nonsurgical option for scoliosis treatment. It uses exercises customized for each patient to return the curved spine to a more natural position. The goal of Schroth exercises is to de-rotate, elongate and stabilize the spine in a three-dimensional plane. it will be applied 3 session per week for 3 months.
Arm Title
Functional Electrical Stimulation
Arm Type
Experimental
Arm Description
30 minutes of Functional Electrical Stimulation (FES) three times a week for 3 months. Two electrodes were attached on the lateral parts of the convex side of the body, and two others on the erector spinae muscles. FES (CU-FS1; Novastim, Korea) was set at a frequency of 35 Hz, with a 250-μs pulse width. Electrical stimulation lasted for 6 seconds, followed by a 6-second rest.
Intervention Type
Other
Intervention Name(s)
Schroth Exercise
Intervention Description
two month (three session per week)
Intervention Type
Other
Intervention Name(s)
Functional Electrical Stimulation (physiotherapy techniques)
Intervention Description
two month (three session per week)
Primary Outcome Measure Information:
Title
cobb angle
Description
The measurement of Cobb angle involves estimating the angle between the two tangents of the upper and lower end-plates of the upper and lower end vertebra, respectively.
Time Frame
at the beginning of the study
Title
cobb angle
Description
The measurement of Cobb angle involves estimating the angle between the two tangents of the upper and lower end-plates of the upper and lower end vertebra, respectively
Time Frame
by the end of successful two month of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children in this group will be healthy category according to CDC (Centers for Disease Control and Prevention) growth chart which ranged from BMI-for-age 5th to 85th percentiles .
All children are normal &perform all activities of daily living
They were able to understand and follow verbal commands and instructions included in the testing procedures.
Exclusion Criteria:
All of them could be part of recreational activities in their public schools but no competitive sports.
Children who participated in any regular sport activities involving the lower extremities will be excluded.
None of them had any surgical intervention .
None of them had any history of other musculoskeletal deformities or neuromuscular disorders.
They had neither visual, auditory defect.
Facility Information:
Facility Name
Amira Hussin Mohammed
City
Gamasa
ZIP/Postal Code
35712
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities
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