CClinicalTrials.gg
SuspendedNCT05951491Updated May 4, 2026

Improving Arm Function Using Wearable Exoskeletons

An interventional study of Wearable Shoulder Exoskeleton and Wearable Hand Exoskeleton in Hemiparesis; Poststroke/CVA, sponsored by University of Idaho. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Idaho · Not applicable, Interventional, and Other

Why this study was suspended
Several prototype improvements affecting comfort and function were identified during the initial fit and range of motion testing and were deemed important to address prior to proceeding with the at-home testing phase.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This study will collect preliminary data evaluating a body-mounted assistive exoskeleton to facilitate the use of arms impaired by stroke to complete everyday tasks. The central hypothesis is that portable exoskeletons will increase reachable area to enhance function and use of the impaired limb. The rationale for this approach builds on well-established literature on the effects of shoulder unloading on increasing arm workspace in stroke.

A convenience sample of 30 subjects with chronic impairment will be recruited to participate. Participants must have sustained a single stroke, be at least 6-months post stroke, and be in stable condition with residual impairment affecting arm function. Patient metadata will include age, race, gender, height, weight, affected side, and time since stroke. Standardized tests of arm function will measure performance scores of chronic-stage stroke-impaired subjects with and without assistance from the exoskeleton. As a consistency check, scores will be evaluated by at least two independent raters on the same day. The central hypothesis will be tested to achieve our objective through the following 3 specific aims:

Aim 1. Demonstrate that gravity support from a portable exoskeleton can increase the reachable workspace following stroke. Gravity support reduces abnormal muscle synergies (i.e., co-activation patterns) during arm reach tasks, but has not been demonstrated in non-sedentary adults with impairment. The approach combining carbon-fiber reinforced 3D-printed plastics, natural rubber-based energy storage, and customized force profile mechanisms allows similar mechanics that have demonstrated success in stationary arm-supports but in a portable package. To test if similar results can be achieved with a new lightweight system, participants will attempt to perform maximal area sweeps in each of three directional planes (sagittal, frontal, transverse) under two experimental conditions (unassisted, assisted by our portable exoskeleton). The reach workspace in each plane will be measured by kinematic data from a 5-camera Optitrack motion capture system with the wrist center taken as the reach endpoint. It is anticipated that use of the portable exoskeleton will produce highly significant improvements in all three planar reach workspace directions in comparison to unassisted movement, similar to what has been demonstrated previously with stationary (i.e., heavy) robotic systems in the transverse plane.

Aim 2. Determine if a portable shoulder exoskeleton can improve hand function following stroke. While shoulder unloading is known to improve reachable work area by reducing co-contraction of biceps, it may or may not sufficiently reduce co-contraction of wrist muscles, leaving the subject able to reach but not grasp objects. A secondary assistive device at the wrist may be needed by some individuals to allow them to open the hand enough to interact with household objects. To evaluate, the impaired participants will perform simultaneous wrist and finger extension while wearing the shoulder exoskeleton and attempt 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. For those that are unable to grasp objects from ARAT and WMFT test kits, wrist and finger joint angles will be recorded along with the amount of assistance required to extend the fingers and thumb into a functional grasping pose. It is anticipated that notable improvements in assessment test scores will result from portable assistance, and that the finger extension test will stratify the population into two groups: a) those that do not need additional hand assistance, and b) those that need both shoulder and hand assistance (powered or non-powered) in order to interact with the test objects.

Aim 3. Quantify the effects of assistance from a portable shoulder exoskeleton on changes in functional use of the impaired limb in clinical and home settings. Increasing range of motion does not always lead to functional improvements in daily tasks that involve both arm positioning and fine motor control in the hand. This work will assess changes in functional use of daily objects using well-established clinical assessment tests followed by an in-home trial of a custom-fit portable exoskeleton. Participants with impairment will perform 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. Participants will then complete 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. At the end of the in-home period, participants will complete a System Usability Scale and a second MAL corresponding with the activities performed while wearing the exoskeleton. It is anticipated that subjects will complete more tasks in less time, with less effort, and with higher success rates in both clinic tests and at-home evaluations.

If successful, body-mounted exoskeletons have the potential to allow ubiquitous training and recovery of arm function at home, dramatically extending therapeutic training time of patients with long-term deficits.

02

Conditions studied

  • Hemiparesis; Poststroke/CVA

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • currently pregnant
  • under 18
  • incarcerated
  • severe pain with arm or hand movement
  • inability to understand verbal or visual instructions
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Chronic Stroke

    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

  • DeviceWearable 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.

    Also known as: Wearable-S

  • DeviceWearable 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.

    Also known as: Wearable-H

05

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

  1. Unassisted Arm Use at Home (without device)

    Ratio of impaired to unimpaired arm movement tracked by activity monitors at home over a span of 3-5 days without exoskeleton assistance.

    Time frame: up to 5 days

  2. Unassisted Arm Use at Home (with device)

    Ratio of impaired to unimpaired arm movement tracked by activity monitors at home over a span of 3-5 days with exoskeleton assistance.

    Time frame: up to 5 days

Other outcomes

  1. Motor Activity Log

    Change in self-reported activities during at-home phase with device assistance.

    Time frame: up to 2 weeks

  2. Range of motion change

    Percent change in planar range of motion in the sagittal, frontal, and transverse planes by wearing the assistive device.

    Time frame: up to 2 weeks

06

Study locations

1 site
  • University of Idaho Integrated Research and Innovation Center
    Moscow, Idaho 83844, United States
07

References and documents

Individual participant data

Plan to share: Yes — The results of the study will be presented at conferences, targeting the Annual Society of Neurorehabilitation and at the annual Mountain West Clinical \& Translational Research Infrastructure Network (MW CTR-IN) conference in Las Vegas, Nevada. We plan to disseminate the full results of the trial via appropriate peer-reviewed journals in a timely manner and make de-identified datasets available via the University of Idaho Library. The informed consent documents for the clinical trial will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov. All data from individual participants will be anonymized or provided in aggregate form prior to sharing.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05951491
Lead sponsor
University of Idaho
Collaborators
University of California, Irvine
Responsible party
Joel Perry (Associate Professor, University of Idaho) — Principal investigator
First posted
Jul 19, 2023
Start date
Jun 18, 2024
Primary completion
May 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
May 4, 2026

Study contacts

Joel C Perry, PhD
principal investigator · University of Idaho

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion