HABIT-ILE + FST in Children With SMA: Preliminary Effectiveness
ConditionSpinal Muscular Atrophy (SMA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorTeachers College, Columbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a confirmed SMA diagnosis
Be 5-17 years old
Complete all pre- and post-intervention assessments
Understand and speak English
Disqualifiers
Orthopedic surgery within the past year
New pharmaceutical treatment during the study
Concurrent participation in another clinical trial
Trial design
Design model
Single group
Treatments tested in this trial
Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST)
Other interventionGoal-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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: HABIT-ILE + FSTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hammersmith Functional Motor Scale - Expanded (HFMSE)
Gross motor function measure; range: 0 to 66; higher scores indicate better motor function
Time frame
3 assessments: Baseline, immediately after the intervention, 3 months follow-upSecondary outcomes
1
Surface electromyography (sEMG)
Surface electromyography (sEMG) will be recorded from muscles of both lower extremities to assess rehabilitation-induced neuroplasticity and neuromuscular adaptations, including muscle fatigability and motor unit recruitment, during standardized endurance tasks.
Time frame
3 assessments: Baseline, immediately after the intervention, 3 months follow-up2
Revised Upper Limb Module (RULM)
Upper limb function measure; range: 0 to 37; higher scores indicate better uper limb function
Time frame
3 assessments: Baseline, immediately after the intervention, 3 months follow-up3
Endurance Shuttle box and blocks test (ESBBT)
Dexterity and upper extremity endurance/fatigability; range: O to 20 minutes (time to limitation); higher times correspond to better endurance
Time frame
3 assessments: Baseline, immediately after the intervention, 3 months follow-up4
6-Minute Walk Test (6MWT)
Walking endurance measure; range: 0 meters to the maximim distance the participant can walk in 6 minutes; higher distances reflect better ambulatory function and endurance.
Time frame
3 assessments: Baseline, immediately after the intervention, 3 months follow-upSponsors and contacts
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Source ClinicalTrials.gov