HABIT-ILE + FST in Children With SMA: Preliminary Effectiveness

NCT07488338 | Recruiting

• 1 other identifier: 25-429-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hammersmith Functional Motor Scale - Expanded (HFMSE)

  Gross motor function measure; range: 0 to 66; higher scores indicate better motor function

  3 assessments: Baseline, immediately after the intervention, 3 months follow-up

Secondary Outcomes (12)

• Surface electromyography (sEMG)

  3 assessments: Baseline, immediately after the intervention, 3 months follow-up

• Revised Upper Limb Module (RULM)

  3 assessments: Baseline, immediately after the intervention, 3 months follow-up

• Endurance Shuttle box and blocks test (ESBBT)

  3 assessments: Baseline, immediately after the intervention, 3 months follow-up

• 6-Minute Walk Test (6MWT)

  3 assessments: Baseline, immediately after the intervention, 3 months follow-up

• 10 Meter Walking Test (10MWT)

  3 assessments: Baseline, immediately after the intervention, 3 months follow-up

Study Arms (1)

HABIT-ILE + FST

EXPERIMENTAL

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.

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

Interventions

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

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

HABIT-ILE + FST

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Orthopedic surgery within the past year
• New pharmaceutical treatment during the study
• Concurrent participation in another clinical trial

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Center for Cerebral Palsy Research, Teachers College, Columbia University

New York, New York, 10021, United States

RECRUITING

Related Publications (3)

• Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30.

  PMID: 28133725 BACKGROUND

• Bleyenheuft Y, Gordon AM. Hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) for children with cerebral palsy. Phys Occup Ther Pediatr. 2014 Nov;34(4):390-403. doi: 10.3109/01942638.2014.932884. Epub 2014 Oct 1.

  PMID: 25271469 BACKGROUND

• Mercuri E, Finkel RS, Muntoni F, Wirth B, Montes J, Main M, Mazzone ES, Vitale M, Snyder B, Quijano-Roy S, Bertini E, Davis RH, Meyer OH, Simonds AK, Schroth MK, Graham RJ, Kirschner J, Iannaccone ST, Crawford TO, Woods S, Qian Y, Sejersen T; SMA Care Group. Diagnosis and management of spinal muscular atrophy: Part 1: Recommendations for diagnosis, rehabilitation, orthopedic and nutritional care. Neuromuscul Disord. 2018 Feb;28(2):103-115. doi: 10.1016/j.nmd.2017.11.005. Epub 2017 Nov 23.

  PMID: 29290580 BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Central Study Contacts

Andrew M Gordon, PhD

CONTACT

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

Astrid Carton de Tournai, PhD

CONTACT

apc2187@tc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-group intervention trial

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 23, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)