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RECRUITINGINTERVENTIONAL

Outpatient Rehabilitation Intervention for Young Children With SMA

Twice Weekly Outpatient Rehabilitation Intervention for Young Children With Spinal Muscular Atrophy Treated With Genetic Based Therapies: A Feasibility Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

An outpatient rehabilitation program for children (6 months to less than 6 years old) with Spinal Muscular Atrophy (SMA) treated with genetic based therapies is being studied. Participants will participate in a 12-week therapy program where they receive 45 minutes each of occupational therapy and physical therapy each week. Home exercises will also be prescribed to be completed 5 days per week. At the end of the therapy program, there will be a 12-week period of no therapy where only home exercises will be completed. Assessments and program evaluation will occur at the beginning (Week 0) and end of the rehabilitation program (Week 24), then at the end of the no therapy block (week 24).

Who May Be Eligible (Plain English)

Who May Qualify: - SMA (Type I, II or III) diagnosis; - Receives genetic based therapy; - Aged 6 months to less than 6 years old; - Able to participate in weekly therapy at Holland Bloorview (i.e., can attend in-person sessions); - Able to bring appropriate respiratory equipment to weekly therapy sessions, if required; - Substitute decision makers (SDMs) must be able to speak and read English; - Child participant must be able to understand/follow directions in English, as age appropriate; - SDMs must consent to participate on behalf of their child. Who Should NOT Join This Trial: - Live outside of Ontario; - Tracheostomy or use of daytime ventilation (excluding ventilation used during naps). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * SMA (Type I, II or III) diagnosis; * Receives genetic based therapy; * Aged 6 months to less than 6 years old; * Able to participate in weekly therapy at Holland Bloorview (i.e., can attend in-person sessions); * Able to bring appropriate respiratory equipment to weekly therapy sessions, if required; * Substitute decision makers (SDMs) must be able to speak and read English; * Child participant must be able to understand/follow directions in English, as age appropriate; * SDMs must consent to participate on behalf of their child. Exclusion Criteria: * Live outside of Ontario; * Tracheostomy or use of daytime ventilation (excluding ventilation used during naps).

Treatments Being Tested

OTHER

Rehabilitation Intervention

12-week treatment intervention \& home exercised, then 12-week non-intervention period, follow-up visit at end of non-intervention period.

Locations (1)

Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada