Self Correction Exercises for Idiopathic Scoliosis Among Adolescents. A Randomised Controlled Trial

NCT03779581 | Completed

• 1 other identifier: MajmaahUniversity
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity with an unknown cause that affects adolescents aged 10 or older. A standing posterior-anterior radiograph with a Cobb angle greater than 10 degrees is used to make the diagnosis. Depending on the severity of the spinal deformity, conservative treatments and surgery are used to treat AIS. Patients whose spinal curvature is greater than 45 degrees are typically considered for surgery. The majority of patients with AIS receive conservative treatments to prevent and slow the progression of the curve. 2 Orthotic intervention (OI) and scoliosis-specific exercise (SSE) are commonly recommended by the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment for patients with a curvature between 20 and 45 degrees. Self correction exercises are the group of spinal extension, lateral spinal flexion and rotational exercises performed to correct spinal deviation. Exercises are performed in a different fundamental postures.

Conditions

Scoliosis Idiopathic

Outcome Measures

Primary Outcomes (2)

• Cobb angle

  Angulation calculated on X-ray

  1-2 hours

• SRS 22

  Scoliosis rating scale 22 items

  1-2 hours

Study Arms (2)

Exercise Group

EXPERIMENTAL

The experimental group received active self-correction exercises to restore movements in different planes as close as possible to physiologically normal.

Other: Self Correction exercises

Control Group

ACTIVE COMPARATOR

All patients were prescribed a spinal orthosis (TLSO) and got a preliminary evaluation for orthosis design and manufacturing based on the curve type categorization from Ross and Weiss during the first appointment (Rigo et al., 2010).

Device: orthotic devices

Interventions

Self Correction exercises OTHER

Active self-correction exercises to restore movements in different planes as close to physiologically normal as possible.

Exercise Group

orthotic devices DEVICE

the orthotic devices designed to correct the scoliosis curve

Control Group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Majmaah University: lead

Study Sites (1)

Faizan Kashoo

Riyadh, 11952, Saudi Arabia

Location

MeSH Terms

Interventions

Orthotic Devices

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher, surgeons, and physiotherapist did not participate in randomization, treatment, or outcome assessments. The assessor was blinded. A computer-generated sequence inside pre-sealed opaque envelopes with sequentially numbered opaque envelopes randomly allocated individuals to the groups. To ensure a fair distribution of curve types between the two groups (54 per group), a random size (4-8) blocked randomization was stratified for the six curve types. Participants were asked not to reveal their group affiliations to ensure evaluators were blind. The statistician was also insulated from group allocation coding. During routine clinic visits, a trained technician blinded to study participation took radiographs. An expert blinded to groups and time measured the radiographs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of physical Therapy and Health Rehabilitation

Model Details: 1431 of the 108 subjects visiting out-patient Department of our hospital met the inclusion criteria. All the subjects diagnosed with kyphoscoliosis signed the informed consent approved by the ethical committee of the hospital. The diagnosis was based on the diagnosis by an experienced radiologist. Subjects with idiopathic kyphoscoliosis and Cobb's angle greater than 60 degree and normal pulmonary function were included. The subjects with other cardiovascular pathologies, congenital disorders and inability to commute were excluded from this study.

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2018
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

SA (1)