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Rehabilitation for Spinal Muscular Atrophy

N/A
Recruiting
Research Sponsored by Holland Bloorview Kids Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SMA (Type I, II or III) diagnosis
Receives genetic based therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 12, week 24
Awards & highlights

Study Summary

This trial studies an outpatient rehab program for SMA-affected children ages 6 months - 3 years, providing 45 minutes of OT & PT per week plus home exercises for 12 weeks, followed by 12 weeks without therapy. Assessments & program evaluations at start & end.

Who is the study for?
This trial is for young children aged 6 months to 3 years with Spinal Muscular Atrophy (SMA) who are treated with genetic therapies. They must be able to attend weekly therapy in Ontario, handle instructions in English, and have a guardian's consent. Children requiring tracheostomy or daytime ventilation (except during naps) cannot participate.Check my eligibility
What is being tested?
The study tests a rehabilitation program combining occupational and physical therapy for SMA-affected children receiving genetic treatments. It involves a structured 12-week therapy followed by another 12 weeks where only home exercises are prescribed.See study design
What are the potential side effects?
Since the intervention is non-drug based, focusing on physical and occupational therapy, traditional medication side effects aren't expected. However, there may be fatigue or muscle soreness associated with increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Spinal Muscular Atrophy (SMA) Type I, II, or III.
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I am receiving treatment that targets my cancer's genetic changes.
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I am between 6 months and 3 years old.
Select...
I can attend weekly therapy sessions in person at Holland Bloorview.
Select...
I can bring my breathing device to weekly therapy sessions if needed.
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My child can understand and follow instructions in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 12, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 12, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM)
Bayley Scales of Infant and Toddler DevelopmentTM, 4th Edition
Canadian Occupational Performance Measure (COPM)
+5 more
Other outcome measures
Demographics Survey

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Participants will participate in the rehabilitation intervention.

Find a Location

Who is running the clinical trial?

Holland Bloorview Kids Rehabilitation HospitalLead Sponsor
66 Previous Clinical Trials
14,054 Total Patients Enrolled

Media Library

Rehabilitation Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05638750 — N/A
Spinal Muscular Atrophy Research Study Groups: Intervention
Spinal Muscular Atrophy Clinical Trial 2023: Rehabilitation Intervention Highlights & Side Effects. Trial Name: NCT05638750 — N/A
Rehabilitation Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05638750 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accept elderly participants?

"This clinical trial's eligibility criteria requires participants to be aged between 6 Months and 3 Years. There are 49 studies for minors and 154 examinations that elderly patients can volunteer in."

Answered by AI

What is the highest number of participants this research endeavor can accommodate?

"Affirmative. Clinicaltrials.gov confirms that this research endeavor, which was first unveiled on the 1st of January 2022, is still ongoing and looking for applicants. Aspiring participants will be drawn from a single location with only 10 spots available in total."

Answered by AI

Are any additional participants being solicited to join this experiment?

"Affirmative, the data from clinicaltrials.gov indicates that this trial is actively recruiting patients. Initially posted on January 1st 2022 and last updated on August 2nd 2023, 10 volunteers need to be recruited at one site."

Answered by AI

Who would be a suitable candidate for participating in this experiment?

"This investigation seeks 10 infants or toddlers between 6 months and 3 years of age with Spinal muscular atrophy. Prospective participants must fulfil the following requirements: SMA (Type I, II or III) diagnosis; genetic based therapy; attend weekly in-person sessions at Holland Bloorview; bring suitable respiratory devices to each session if required; substitute decision makers that are able to converse and read English fluently; child's capacity to comprehend/follow directions in English as appropriate for their age group; SDMs' permission on behalf of the participating minor."

Answered by AI
~3 spots leftby Mar 2025