N/A
Completed N=98
Scoliosis-Specific Exercises for At-Risk AIS Curves
Source: ClinicalTrials.gov NCT02807545 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Overall Recruitment Rate — 1; 1 Participants
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.
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 | — |
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. Informational only — not medical advice.