Improving Arm Function Using Wearable Exoskeletons

NCT05951491 | Suspended

• 1 other identifier: 23-041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• BBT change in score

  Percent change in Box and Blocks Test score WITH vs. WITHOUT the assistive exoskeleton. Blocks are moved from one bin over a barrier to another bin in 1 minute. The number of blocks successfully transferred over the barrier is the score. BBT Minimum scale value = 0 (worst performance). BBT improvement = ( (score with exo) - (score without exo) ) / (score without exo) \* 100

  Scores with and without exoskeleton assistance are measured during a single session not more than 30 minutes apart.

• ARAT change in score

  Percent change in Action Research Arm Test score WITH vs. WITHOUT the assistive exoskeleton. 19 tasks are scored on a scale from 0-3. ARAT Minimum scale value = 0 (worst performance). ARAT Maximum scale value = 57 (best performance). ARAT improvement = ( (score with exo) - (score without exo) ) / (score without exo) \* 100

  Scores with and without exoskeleton assistance are measured during a single session not more than 30 minutes apart.

Secondary Outcomes (2)

• Unassisted Arm Use at Home (without device)

  up to 5 days

• Unassisted Arm Use at Home (with device)

  up to 5 days

Other Outcomes (2)

• Motor Activity Log

  up to 2 weeks

• Range of motion change

  up to 2 weeks

Study Arms (1)

Chronic Stroke

EXPERIMENTAL

Individuals more than 6 months post-stroke in stable condition with long-term impairment affecting the arm and hand.

Device: Wearable Shoulder Exoskeleton; Device: Wearable Hand Exoskeleton

Interventions

Wearable Shoulder Exoskeleton DEVICE

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.

Also known as: Wearable-S

Chronic Stroke

Wearable Hand Exoskeleton DEVICE

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.

Also known as: Wearable-H

Chronic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have arm and hand impairment resulting from a single stroke that occurred more than 6 months ago.
• have some volitional extension of the wrist and fingers to grasp small objects and the ability to elevate the shoulder at least 15 degrees.

You may not qualify if:

• currently pregnant
• under 18
• incarcerated
• severe pain with arm or hand movement
• inability to understand verbal or visual instructions

Sponsors & Collaborators

• University of Idaho: lead
• University of California, Irvine: collaborator

Study Sites (1)

University of Idaho Integrated Research and Innovation Center

Moscow, Idaho, 83844, United States

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel C Perry, PhD

  University of Idaho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 30 participants will enroll in a first assessment phase in a laboratory stetting comparing function with and without assistance from a wearable system. A subset of these (approximately 12) will enroll in a subsequent at-home phase.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 19, 2023
• Study Start: June 18, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available at the conclusion of the study for at least 25 years.
• Access Criteria: There will be no restrictions for access to deidentified data, both summarized and individual.

Locations

US (1)