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Body Weight Support Harness System for Spinal Muscular Atrophy
N/A
Waitlist Available
Led By Megan A Iammarino, DPT
Research Sponsored by Nationwide Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed at baseline, 3 months, and 6 months
Awards & highlights
Study Summary
This trial is studying if an in-home harness system is a safe, feasible, and useful tool for children treated for spinal muscular atrophy.
Eligible Conditions
- Spinal Muscular Atrophy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed at baseline, 3 months, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed at baseline, 3 months, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver survey
Change in Bayley Scales of Infant and Toddler Development 3rd ed. (Bayley-III), Gross motor subtest
Change in Hammersmith Functional Motor Scale Expanded (HFMSE)
+3 moreSecondary outcome measures
Harness use log
Trial Design
1Treatment groups
Experimental Treatment
Group I: In-home body weight support harness systemExperimental Treatment1 Intervention
All participants will be entered into treatment arm and receive an in-home body weight support harness system
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Who is running the clinical trial?
Nationwide Children's HospitalLead Sponsor
341 Previous Clinical Trials
5,220,473 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,002 Total Patients Enrolled
Megan A Iammarino, DPTPrincipal InvestigatorNationwide Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have four or more copies of the SMN2 gene, which is linked to spinal muscular atrophy (SMA) types 3 and 4.You weigh less than 50 pounds.You have recently injured your lower limb or had a fracture.You have a specific genetic mutation related to spinal muscular atrophy.You have been treated with nusinersen, onasemnogene abeparvovec, or risdiplam in the past or are currently receiving these treatments.You can lift your head up from bending forward.Verified difficulty with moving and coordinating the body.
Research Study Groups:
This trial has the following groups:- Group 1: In-home body weight support harness system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for patients to participate in this trial?
"According to the information on clinicaltrials.gov, recruitment for this trial has ceased as of January 27th 2023. This study was originally posted in September 7th 2018 and it is no longer searching for participants. Nevertheless, there are presently 345 other trials that are actively seeking new enrollees."
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