Schroth Exercise Versus Functional Electrical Stimulation in Adolescent With Spinal Deformities

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).

Study Overview

• Status: Completed
• Conditions: Idiopathic Spinal Deformities
• Intervention / Treatment: Other: Schroth Exercise; Other: Functional Electrical Stimulation (physiotherapy techniques)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gamasa, Egypt, 35712
    • Amira Hussin Mohammed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Schroth Exercise; 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.	Other: Schroth Exercise; two month (three session per week)
Experimental: Functional Electrical Stimulation; 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.	Other: Functional Electrical Stimulation (physiotherapy techniques); two month (three session per week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at the beginning of the study
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	by the end of successful two month of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vital capacity and forced vital capacity and maximum ventilatory volume	Forced expiratory volume measures how much air a person can exhale during a forced breath. Forced vital capacity is the total amount of air exhaled during the Forced expiratory volume test. Maximal voluntary ventilation is defined as the maximum minute volume of ventilation that the subject can maintain for 12 to 15 s.	at the beginning of the study
vital capacity and forced vital capacity and maximum ventilatory volume	Forced expiratory volume measures how much air a person can exhale during a forced breath. Forced vital capacity is the total amount of air exhaled during the Forced expiratory volume test. Maximal voluntary ventilation is defined as the maximum minute volume of ventilation that the subject can maintain for 12 to 15 s.	by the end of successful two month of intervention

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: schroth exercises

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No