Scoliosis-Specific Exercises for At-Risk AIS Curves

NCT02807545 | Completed Results DMC

• 1 other identifier: 12-15-1203
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 6

Brief Summary

This study will be a multi-center, dual-arm randomized control study evaluating skeletally immature patients with mild AIS curves. At six institutions, patients will be randomized into either the scoliosis-specific exercise (SSE) treatment arm or a control group. The SSE group will receive training in SSE, posture, and activities of daily living by physical therapists certified in Schroth-based exercise methods. The control group will not receive SSE instruction and will only be observed by their treating orthopaedic surgeon (which is considered the standard-of-care treatment method). Results will be compared after one year of treatment.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Scoliosis-Specific Exercises; Schroth

Outcome Measures

Primary Outcomes (3)

• Overall Recruitment Rate

  Measured by the number of participants enrolled through study completion.

  through study completion up to 45 months

• Treatment Attendance in the SSE Group

  Measured by the number of prescribed hours of physical therapy sessions attended after 1 year

  after 1 year

• Home Exercise Adherence in the SSE Group According to Weekly E-mails

  Measured by the percentage of prescribed exercises completed from baseline to 1 year

  1 year

Secondary Outcomes (3)

• Curve Magnitude

  1 year

• Curve Progression

  after 1 year

• Brace Prescription

  after 1 year

Study Arms (2)

Physical Therapy Exercise Group

EXPERIMENTAL

Each patient assigned to the SSE group will attend at least 8 hours of supervised exercise training led by a Schroth-based certified physical therapist over the course of 6 months. Ideally, patients will be seen for 7 sessions. Patients will perform a home exercise program for 15 minutes a day, 5 days a week, when they can independently execute their prescribed exercises. An exercise log initialed by the guardian will help families keep track of their exercise adherence and serve as a way to monitor exercise adherence for patients who may not have a smartphone, tablet, or computer. Patients will also be able to meet with the therapists at their return-to-clinic visits and every 2-3 months thereafter until their 1 year follow-up to assess performance quality, maintain motivation, and progress intensity. Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.

Behavioral: Scoliosis Specific Exercises

Control Group

NO INTERVENTION

Patients randomized to this group will continue receiving standard-of-care treatment from their orthopaedic physician which includes regularly scheduled clinic visits and observation. Observation consists of no treatment of the scoliosis, only routine clinical assessment by the orthopaedic surgeon to detect curve progression every 3 to 6 months.

Interventions

Scoliosis Specific Exercises BEHAVIORAL

Also known as: Schroth-Based Method

Physical Therapy Exercise Group

Eligibility Criteria

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

You may qualify if:

• Age 10 to 17 years
• Major curve Cobb angles of 12° to 24°
• Risser Grade 0
• Single thoracic, thoracolumbar, or lumbar curve patterns

You may not qualify if:

• Scoliosis other than AIS (congenital, neuromuscular, etc)
• Upper thoracic or double curve patterns
• Diagnosis of a developmental disorder that prevents understanding and compliance with an exercise schedule
• Current or previous brace wear
• Previous participation in a SSE program
• Previous spine surgery
• Patient inability to commit to attend at least 8 hours of PT within 6 months

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead
• Scoliosis Research Society: collaborator
• Boston Children's Hospital: collaborator
• Columbia University: collaborator
• Norton Leatherman Spine Center: collaborator
• Johns Hopkins University: collaborator
• Baylor College of Medicine: collaborator

Study Sites (6)

Norton Leatherman Spine Center

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Texas Scottish Rite Hospital for Children

Dallas, Texas, 75219, United States

Location

Texas Children's Hospital

Houston, Texas, 75235, United States

Location

Results Point of Contact

• Title: Karina Zapata
• Organization: Scottish Rite for Children

karina.zapata@tsrh.org

214-559-7790

Study Officials

• Karina Zapata, PhD

  Scottish Rite for Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 21, 2016
• Study Start: August 2, 2016
• Primary Completion: August 31, 2021
• Study Completion: October 1, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)