Trials / Unknown
UnknownNCT05409079
Schulze Muscular Dystrophy Ability Clinical Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- AbiliTech Medical Inc. · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the Schulze study is to evaluate the function of the upper limbs of subjects diagnosed with neuromuscular disorders, with and without use of the Abilitech Assist device in the clinic and home environments. Functional outcomes will include documenting active range of motion and the ability to perform activities of daily living (ADLs) using the standardized Canadian Occupational Performance Measure (COPM) and the Role Evaluation of Activities of Life (REAL) assessments. Secondary objectives are to assess the safety record and report on adverse events (AEs) and parameters related to device usage, including device usage time and the time required to don/doff the device. Secondary objectives also include characterization of user upper limb performance based on etiology.
Conditions
- Muscular Dystrophies
- Spinal Muscular Atrophy
- Duchenne Muscular Dystrophy
- Limb Girdle Muscular Dystrophy
- FSHD
- Cerebral Palsy
- Becker Muscular Dystrophy
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Abilitech Assist | The Abilitech™ Assist is an externally worn device supported by a body frame, which is designed to support and assist the arms in activities of daily living (ADL's). The Abilitech Assist is comprised of three parts: a modular body vest that adjusts to accommodate different body sizes, a single arm orthosis that attaches to the body vest, and an external power pack and controller for tensioning the arm's internal springs to adjust the arm's level of assist. The device augments a user's native arm function to provide lift assistance. Software customizes the spring tension for the level of assist required. The user can turn the system ON/OFF and toggle and adjust the level of assist (e.g., low, medium or high assist) using a pushbutton controller. |
Timeline
- Start date
- 2022-05-26
- Primary completion
- 2023-06-30
- Completion
- 2023-06-30
- First posted
- 2022-06-08
- Last updated
- 2022-12-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05409079. Inclusion in this directory is not an endorsement.