HABIT-ILE plus Functional Strength Training for Children with SMA
Feasibility and Preliminary Effectiveness of HABIT-ILE + Functional Strength Training in Children With Spinal Muscular Atrophy (SMA): a Prospective Single-group Intervention Trial.
This study will try an intensive HABIT-ILE program combined with functional strength training for children aged 5–17 with SMA who are on stable disease-modifying therapy to see if it improves motor skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Teachers College, Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07488338 on ClinicalTrials.gov |
What this trial studies
This is a single-arm pilot enrolling children with SMA who have been on a stable disease-modifying therapy for at least six months. Participants attend a supervised HABIT-ILE plus functional strength training summer camp for 6 hours per day over three weeks (90 total hours) with standardized pre- and post-intervention assessments. The intervention integrates high-intensity bimanual and lower-extremity motor skill practice with progressive functional strengthening based on motor learning principles. Outcomes will measure preliminary changes in motor function and daily activity performance to inform larger controlled trials.
Who should consider this trial
Good fit: Ideal candidates are children 5–17 years old with confirmed SMA (types 2 or 3 classified as sitters or walkers), able to stand with support, fluent in English, able to follow instructions, and on a stable DMT dose for six months or more.
Not a fit: Children who recently had orthopedic surgery, started a new medication, are enrolled in another clinical trial, cannot attend the in-person camp, or lack the required standing ability or cognitive/behavioral cooperation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined program could improve motor abilities and real-world function beyond what medication alone provides.
How similar studies have performed: HABIT-ILE has shown motor benefits in other pediatric motor disorders such as cerebral palsy, but its use specifically in children with SMA and combined with DMTs remains limited and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have a confirmed SMA diagnosis * Be 5-17 years old * Complete all pre- and post-intervention assessments * Understand and speak English * Follow instructions without major cognitive or behavioral issues * Have received a stable disease-modifying therapy (DMT) dose for ≥6 months * Be classified as a sitter or walker (SMA type 2 or 3) with supported standing ability (score ≥1 on Item 18 of the HFMSE) without KAFOs, AFOs, or external standing devices Exclusion Criteria: * Orthopedic surgery within the past year * New pharmaceutical treatment during the study * Concurrent participation in another clinical trial
Where this trial is running
New York, New York
- Center for Cerebral Palsy Research, Teachers College, Columbia University — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Andrew M Gordon, PhD
- Email: ag275@tc.columbia.edu
- Phone: +1(212) 678-3332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.