Improving Arm Function Using Wearable Exoskeletons
NCT05951491 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-04
Summary
The goal of this clinical trial is to compare arm and hand function with and without assistance from a wearable exoskeleton in individuals with neurological injury from a single stroke. The main questions it aims to answer are:
* Can a portable (i.e., body-mounted) shoulder exoskeleton increase the reachable workspace of an individual after stroke?
* Can shoulder assistance from a body-mounted exoskeleton improve hand function after stroke?
* Does shoulder assistance from a body-mounted exoskeleton lead to changes in functional use of the impaired limb at home?
Participants will perform tasks with and without assistance from a portable exoskeleton, including:
* maximal area sweeps in each of three directional planes (sagittal, frontal, transverse).
* simultaneous wrist and finger extension while attempting to pick up objects of varying size from the Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT), and Box and Blocks (BBT) test kits.
* standardized clinical assessments in a laboratory setting that have been shown to correlate with functional performance of activities of daily living including WMFT, ARAT, and BBT.
* a Motor Activity Log (MAL) based on activity performed in the past week as a baseline, before wearing the exoskeleton at home for a period of 1-2 hours per day for at least 5 days.
* a System Usability Scale and a second MAL corresponding with the activities performed while wearing the exoskeleton during the at-home phase.
Researchers will compare functional ability measures with and without wearing the portable shoulder exoskeleton to see if the assistance improves functional performance in the arm and/or hand.
Conditions
- Hemiparesis; Poststroke/CVA
Interventions
- DEVICE
-
Wearable Hand Exoskeleton
The wearable hand exoskeleton prototype is under development at the University of Idaho to provide hand-opening support. Subjects will use the device at home for a period of 3-5 days for at least 2 hours per day.
- DEVICE
-
Wearable Shoulder Exoskeleton
The wearable shoulder exoskeleton prototype is under development at the University of Idaho to provide gravity support to the shoulder. Subjects will use the device at home for a period of 3-5 days for at least 2 hours per day.
Sponsors & Collaborators
-
University of California, Irvine
collaborator OTHER -
University of Idaho
lead OTHER
Principal Investigators
-
Joel C Perry, PhD · University of Idaho
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-18
- Primary Completion
- 2027-05-31
- Completion
- 2027-08-31
Countries
- United States
Study Locations
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