Scoliosis-Specific Exercises for At-Risk AIS Curves (EX)
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|ClinicalTrials.gov Identifier: NCT02807545|
Recruitment Status : Unknown
Verified June 2016 by Texas Scottish Rite Hospital for Children.
Recruitment status was: Enrolling by invitation
First Posted : June 21, 2016
Last Update Posted : November 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Behavioral: Scoliosis Specific Exercises||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Scoliosis-Specific Exercises for At-Risk Mild Adolescent Idiopathic Scoliosis Curves: A Multi-Site Preliminary Randomized Trial|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2018|
Experimental: Physical Therapy Exercise Group
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 Patients will be withdrawn if they do not achieve 80% exercise adherence within 6 months.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
Other Name: Schroth-Based Method
No Intervention: Control Group
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.
- Recruitment rate at each site [ Time Frame: 1 year ]Measured by the number of participants enrolled per month at each site
- Overall recruitment rate [ Time Frame: 1 year ]Measured by the total number of participants enrolled.
- Treatment attendance in the SSE group [ Time Frame: 1 year ]Measured by the percentage of prescribed hours of physical therapy sessions attended
- Home exercise adherence in the SSE group according to weekly e-mails [ Time Frame: 1 year ]Measured by the percentage of prescribed exercises completed from baseline to 1 year
- Home exercise adherence in the SSE group according to a smartphone application [ Time Frame: 1 year ]Measured by the percentage of prescribed exercises completed from baseline to 1 year.
- Curve magnitude [ Time Frame: Baseline and 1 year ]Measured by the Cobb angle on radiograph
- Curve progression [ Time Frame: after 1 year ]Measured by whether the curve progress >5 degrees
- Brace prescription [ Time Frame: after 1 year ]Measured by the percentage of participants prescribed a brace
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807545
|United States, Texas|
|Texas Scottish Rite Hospital for Children|
|Dallas, Texas, United States, 75219|