HABIT-ILE + FST in Children With SMA

NCT07223320 | Active Not Recruiting

• 1 other identifier: 25-429
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility questionnaire

  Feasibility questionnaire completed by both the child and their parents to assess the acceptability of the intervention (including child satisfaction and physical comfort, and parent feedback), as well as its demand and practicality.

  Immediately after the intervention

Secondary Outcomes (11)

• Hammersmith Functional Motor Scale -Expanded (HFMSE)

  4 assessments: Baseline 1, baseline 2 (1 week), post intervention (16 weeks), 3 months follow-up

• Revised Upper Limb Module (RULM)

  4 assessments: Baseline 1, baseline 2 (1 week), post intervention (16 weeks), 3 months follow-up

• Endurance Shuttle box and blocks test (ESBBT)

  4 assessments: Baseline 1, baseline 2 (1 week), post intervention (16 weeks), 3 months follow-up

• 6-Minute Walk Test (6MWT)

  4 assessments: Baseline 1, baseline 2 (1 week), post intervention (16 weeks), 3 months follow-up

• 10 Meter Walking Test (10MWT)

  4 assessments: Baseline 1, baseline 2 (1 week), post intervention (16 weeks), 3 months follow-up

Study Arms (1)

Combined 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, one day/week for 15 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

Combined HABIT-ILE + FST

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Center for Cerebral Palsy Research, Teachers College, Columbia University

New York, New York, 10027, United States

Location

Related Publications (3)

• 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

• 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

• 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

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

Study Design

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

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 31, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-09

Locations

US (1)