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Ablelite Pediatric Device Clinical Study

NCT04308447 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-03-16

No results posted yet for this study

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

  • Muscular Dystrophies

Interventions

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.

Sponsors & Collaborators

  • Gillette Children's Specialty Healthcare

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • AbiliTech Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-12-31
Completion
2021-01-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308447 on ClinicalTrials.gov