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Active Not Recruiting NCT05715749

Body Weight Support Harness System in Spinal Muscular Atrophy

Conditions: Spinal Muscular Atrophy Type I, Spinal Muscular Atrophy Type II

Sex: All
Phase: NA
Enrollment: 33
Sponsor: Nationwide Children's Hospital

Location: United States

Summary

The goal of this pilot interventional study is to learn about the use of an in-home harness system in children who have been treated for spinal muscular atrophy. The main questions it aims to answer are:Is the in-home body weight support harness system a feasible option for families to use?Is the in-home body weight support harness system a useful tool for children treated for spinal muscular atrophy?Is the in-home body weight support harness system a safe tool for children treated for spinal muscular atrophy?Participants will be given an in-home body weight support harness system and taught how to use it. Families will document how often and for how long they use the system over 6 months. Children will be given tests of motor function at the beginning, 3-months, and 6-months. At the end of the study, families will be asked to fill out a questionnaire about thier experience using the system.

Eligibility Criteria

Inclusion Criteria:Confirmed heterozygous mutation in SMN1 gene and 2 or 3 copies of SMN2 (historically, SMA Type 1 and Type 2)Past or current treatment with nusinersen, onasemnogene abeparvovec, or risdiplamUpright head control (defined as the ability to lift head from full forward flexion)Weight under or 50lbsConfirmed motor delayExclusion Criteria:4+ copies of SMN2 (historically, SMA Type 3 and 4)Evidence of lower limb injury or recent fractureIn the opinion of the investigator, it was unsafe for the child to participate

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05715749). StuddyBuddy aggregates publicly available trial information.