Trials / Unknown
UnknownNCT04308447
Ablelite Pediatric Device Clinical Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- AbiliTech Medical Inc. · Industry
- Sex
- All
- Age
- 9 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the AbleLite early feasibility study is to evaluate the function of the upper limbs of participants diagnosed with neuromuscular disorders as children, with and without use of the Abilitech AbleLite 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AbleLite | The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living. |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2020-12-31
- Completion
- 2021-01-31
- First posted
- 2020-03-16
- Last updated
- 2020-03-16
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04308447. Inclusion in this directory is not an endorsement.