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HABIT-ILE & FST

Sponsor:

Teachers College, Columbia University

Code:

NCT07223320

Conditions

SMA - Spinal Muscular Atrophy

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 feasibility and 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 one 6-hour HABIT-ILE + FST session each weekend (Saturday or Sunday) for 15 weeks, for a total of 90 hours of training. Feasibility will be evaluated through questionnaires, and effectiveness through standardized motor function assessments.

Conditions

SMA - Spinal Muscular Atrophy

Study ID

NCT07223320

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of SMA
  • Able to participate in all pre and post intervention assessments
  • Able to understand and speak English
  • Able to understand directions (no significant cognitive delay or serious behavioral issues that would limit participation)
  • Receiving a stable dose of disease-modifying therapies for at least 6 months prior to enrollment.

Exclusion Criteria:

  • Orthopedic surgery within the last year (confound)
  • Initiation of any new pharmaceutical treatment during the study period
  • Participation in a clinical trial of an investigational therapy

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combined 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, one day/week for 15 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

  • Feasibility questionnaire [ Time Frame: Immediately after the intervention ]

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, 10027

Contacts

Astrid Carton de Tournai, PhD

+1 (212) 678-3332apc2187@tc.columbia.edu

Principal Investigator:

Andrew M Gordon, PhD

More Information

Sponsor

Teachers College, Columbia University

Last update posted

Oct 31, 2025

Last verified

Sep, 2025

Keywords

  • HABIT-ILE
  • Functional strength training
  • Pediatric
  • Rehabilitation
  • Motor control
  • Intensive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Teachers College, Columbia University on 2025-10-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.