N/A
N=98
Scoliosis-Specific Exercises for At-Risk AIS Curves
Adolescent Idiopathic Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT02807545 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Overall Recruitment Rate — 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Scoliosis Specific Exercises (Behavioral)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Texas Scottish Rite Hospital for Children
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Recruitment Rate |
1; 1 | — |
| PRIMARY Treatment Attendance in the SSE Group |
9.7 | — |
| PRIMARY Home Exercise Adherence in the SSE Group According to Weekly E-mails |
62.8 | — |
| SECONDARY Curve Magnitude |
16.1; 18.1 | — |
| SECONDARY Curve Progression |
8; 7 | — |
| SECONDARY Brace Prescription |
9; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
All patients diagnosed with Adolescent Idiopathic Scoliosis who meet the following inclusion criteria will be eligible to participate in this trial:
- Age 10 to 17 years
- Major curve Cobb angles of 12° to 24°
- Risser Grade 0
- Single thoracic, thoracolumbar, or lumbar curve patterns
Exclusion Criteria
Patients will be excluded according to the following exclusion criteria:
- 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
Data sourced from ClinicalTrials.gov (NCT02807545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.