Recruiting

HABIT-ILE & FST

Sponsor:

Teachers College, Columbia University

Code:

NCT07488338

Conditions

Spinal Muscular Atrophy (SMA)

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)

Study Details

Brief summary:

This single-arm pilot study will assess the preliminary effectiveness of an intensive motor skill intervention (HABIT-ILE) combined with functional strength training (FST) in children with SMA who are receiving disease-modifying therapies. Participants will attend a HABIT-ILE + FST summer camp for 6 hours per day over a 3-week period, totaling 90 hours of training.

Conditions

Spinal Muscular Atrophy (SMA)

Study ID

NCT07488338

Start date

Mar 15, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HABIT-ILE + FST

Participants receive a combined intervention consisting of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Functional Strength Training (FST). Both components are delivered as an integrated, intensive motor learning-based program aimed at improving upper and lower limb function in children with SMA. Subject will participate in a HABIT-ILE + FST camp format for 6 hours/day over 3 weeks.

Interventions

Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)

Goal-directed, task-specific training for both the upper and lower extremity, and postural control with targeted strengthening exercises to enhance motor control and facilitate the achievement of functional goals

Primary outcome measure

  • Hammersmith Functional Motor Scale - Expanded (HFMSE) [ Time Frame: 3 assessments: Baseline, immediately after the intervention, 3 months follow-up ]

Central Contacts and Locations

Central contacts

Andrew M Gordon, PhD

+1(212) 678-3332ag275@tc.columbia.edu

Astrid Carton de Tournai, PhD

apc2187@tc.columbia.edu

Locations

Center for Cerebral Palsy Research, Teachers College, Columbia University

Recruiting

New York, New York, United States, 10021

Contacts

Astrid Carton de Tournai, PhD

(212) 678-3332cpresearch@tc.columbia.edu

More Information

Sponsor

Teachers College, Columbia University

Last update posted

Oct 22, 2026

Last verified

Sep, 2026

Keywords

  • HABIT-ILE
  • Functional Strenght Training
  • Pediatric
  • Rehabilitation
  • Motor control
  • Intensive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Teachers College, Columbia University on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.