Motor Skill and Strength Training for Spinal Muscular Atrophy

Overseen By Andrew M Gordon, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Teachers College, Columbia University

Must be taking: Disease-modifying therapies

Disqualifiers: Orthopedic surgery, New treatments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 15 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of a new treatment approach for children with spinal muscular atrophy (SMA), a condition that weakens muscles. The trial combines two therapies: HABIT-ILE, which improves hand and leg coordination, and Functional Strength Training, which increases muscle strength. The goal is to determine if this combination can enhance motor skills in children already on stable disease-modifying therapies. Children with SMA who understand English and have been on steady treatment for at least six months might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment options for SMA.

Do I need to stop my current medications to join the trial?

You don't need to stop your current medications, but you must be on a stable dose of your disease-modifying therapy for at least 6 months before joining the trial.

What prior data suggests that this motor skill and strength training intervention is safe for children with SMA?

Studies have shown that HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) combined with Functional Strength Training (FST) is generally well-tolerated in children with spinal muscular atrophy (SMA). This intensive training program improves motor skills and strength. Research indicates no major side effects have been reported in previous studies with similar treatments. Participants typically experience only mild discomfort, such as muscle soreness, which is common with any new physical activity. This suggests the treatment is safe for children receiving therapies for SMA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HABIT-ILE + FST for Spinal Muscular Atrophy (SMA) because it combines two innovative therapies into one intensive program. Unlike traditional treatments that may focus on medication or isolated physical therapy exercises, this approach integrates Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) with Functional Strength Training (FST). This dual approach aims to improve both upper and lower limb function through a comprehensive, motor learning-based program. By delivering the treatment in a camp format, participants receive focused, immersive therapy that could lead to more significant improvements in motor skills compared to current options.

What evidence suggests that the HABIT-ILE + FST intervention is effective for improving motor skills in children with SMA?

Research has shown that combining two types of therapy—Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and Functional Strength Training (FST)—can improve motor skills in children with Spinal Muscular Atrophy (SMA). In this trial, participants will receive this combined intervention, which studies have found enhances the function of both arms and legs. Children receiving treatments that modify the disease have shown particularly good results with this intensive training. The program focuses on learning to move better, which improves muscle coordination and strength. These early findings are promising for enhancing movement abilities in kids with SMA. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for children with Spinal Muscular Atrophy (SMA) who are already on disease-modifying therapies. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed inclusion and exclusion information.

Inclusion Criteria

Able to understand and speak English

I can attend all required health checks before and after treatment.

I can follow instructions without any major cognitive or behavioral issues.

Exclusion Criteria

Participation in a clinical trial of an investigational therapy

I have not had orthopedic surgery in the past year.

I will not start any new medications during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combined intervention of HABIT-ILE and FST for 6 hours each weekend over 15 weeks

15 weeks

15 visits (in-person, 6 hours each)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HABIT-ILE + FST

Trial Overview The trial tests a combination of intensive motor skill therapy called HABIT-ILE and functional strength training (FST). Children will participate in one 6-hour session each weekend for 15 weeks, totaling 90 hours of training. The focus is on feasibility and improving motor skills.

How Is the Trial Designed?

Group I: Combined HABIT-ILE + FST Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials

27

Recruited

6,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223320

NCT07223320 | HABIT-ILE + FST in Children With SMA 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 ...

2. trialx.com trialx.com/clinical-trials/listings/325314/habit-ile-fst-in-children-with-sma/

HABIT-ILE + FST in Children With SMA The aim of this pilot proposal is to evaluate the feasibility and preliminary efficacy of HABIT-ILE + FST in children with SMA receiving DMTs.

3. allclinicaltrials.com allclinicaltrials.com/study/NCT07223320

HABIT-ILE + FST in Children With SMA Combined Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) + functional strength training (FST). See if you qualify. Study Details.

4. meddatax.com meddatax.com/clinical-trials/NCT07223320

HABIT-ILE + FST in Children With SMA Combined HABIT-ILE + FST. Participants receive a combined intervention consisting of Hand-Arm Bimanual Intensive Therapy Including Lower ...

5. app.trialscreen.org app.trialscreen.org/trials/habit-ile-fst-children-sma-trial-nct07223320

HABIT-ILE + FST in Children With SMA Back to study results. A pilot interventional study of HABIT-ILE + FST in children with SMA. A study testing intensive motor skills training ...