Body Weight Support Harness System in Spinal Muscular Atrophy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-07

Study Completion Date

2024-07-15

Brief Summary

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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:

1. Is the in-home body weight support harness system a feasible option for families to use?
2. Is the in-home body weight support harness system a useful tool for children treated for spinal muscular atrophy?
3. 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.

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Detailed Description

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Conditions

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Spinal Muscular Atrophy Type I Spinal Muscular Atrophy Type II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Outcomes assessors are masked to previous participant performance.

Study Groups

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In-home body weight support harness system

All participants will be entered into treatment arm and receive an in-home body weight support harness system

Group Type EXPERIMENTAL

In-home body weight support harness system

Intervention Type OTHER

A portable, adjustable body weight support harness system that occupies roughly 9 feet x 9 feet space in the home. The system allows 360 degrees of mobility anywhere within the footprint of the frame. The amount of body weight support is adjustable.

Interventions

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In-home body weight support harness system

A portable, adjustable body weight support harness system that occupies roughly 9 feet x 9 feet space in the home. The system allows 360 degrees of mobility anywhere within the footprint of the frame. The amount of body weight support is adjustable.

Intervention Type OTHER

Other Intervention Names

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The Portable Mobility Aid for Children (PUMA)

Eligibility Criteria

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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 risdiplam
* Upright head control (defined as the ability to lift head from full forward flexion)
* Weight under or 50lbs
* Confirmed motor delay

Exclusion Criteria

* 4+ copies of SMN2 (historically, SMA Type 3 and 4)
* Evidence of lower limb injury or recent fracture
* In the opinion of the investigator, it was unsafe for the child to participate

Eligible Sex

ALL

Accepts Healthy Volunteers

No