Efficacy of Scoliosis Specific Exercise in Patients With Adolescent Idiopathic Scoliosis During Bracing

NCT03305185 | Unknown DMC

• 1 other identifier: UW 16-206
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The goal is to determine if Schroth SSE combined with bracing can is superior in controlling curve progression when compared with bracing alone. Curve progression is defined as worsening of coronal Cobb angle of 6 degrees or more.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

AIS

Outcome Measures

Primary Outcomes (1)

• Effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment

  1\. To evaluate the effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment

  baseline, 3 months, 6 months, 12 months, until skeletal maturity

Secondary Outcomes (9)

• Compare changes in sagittal plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System

  baseline, 3 months, 6 months, 12 months, until skeletal maturity

• Compare changes in transverse plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System

  baseline, 3 months, 6 months, 12 months, until skeletal maturity

• Compare changes in surface topography between Schroth SSE with bracing and bracing alone using Bunnell's scoliometer

  baseline, 3 months, 6 months, 12 months, until skeletal maturity

• Compare changes in surface topography between Schroth SSE with bracing and bracing alone using clinical photography

  baseline, 6 months, 12 months, until skeletal maturity

• Compare changes in surface topography between Schroth SSE with bracing and bracing alone using VITUS Smart XXL 3D body scanner system

  baseline, 6 months, 12 months, until skeletal maturity

Study Arms (2)

Schroth SSE with Bracing

EXPERIMENTAL

Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.

Combination Product: Schroth SSE with Bracing

Bracing alone

ACTIVE COMPARATOR

Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.

Device: Bracing alone

Interventions

Schroth SSE with Bracing COMBINATION_PRODUCT

Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.

Schroth SSE with Bracing

Bracing alone DEVICE

Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.

Bracing alone

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of AIS
• Male or female from 10 to 15 year-old, inclusive, at the time of consent provided
• Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual fusion of the iliac apophysis) of 0, 1, or 2
• Cobb angle of 25-40
• No prior conservative or surgical treatment for AIS

You may not qualify if:

• An underlying cause or association that may cause scoliosis
• Leg length discrepancies or lower limb deformities that may interfere with spinal posture
• Previous spinal surgery
• Cognitive impairment
• Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis
• Those who are unable to return for follow-up to complete the trial.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Dr Kenny Kwan, BMBCh(Oxon)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessor, statistician and investigator blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian. Recruited patients will be randomly assigned to either SSE group or control group in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, post-treatment 3 months, 6 months, 12 months and until skeletal maturity.

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: October 9, 2017
• Study Start: December 18, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)