NCT05090436

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

September 17, 2021

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Schroth Exercise

EXPERIMENTAL

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

Functional Electrical Stimulation

EXPERIMENTAL

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)

Interventions

two month (three session per week)

Schroth Exercise

two month (three session per week)

Functional Electrical Stimulation

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant. Professor of physical therapy, Department of Physical Therapy for Pediatrics

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 22, 2021

Study Start

October 25, 2021

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations