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Hemiparesis; Poststroke/CVANCT05951491

Improving Arm Function Using Wearable Exoskeletons

A study testing Wearable Shoulder Exoskeleton and Wearable Hand Exoskeleton in people with Hemiparesis; Poststroke/CVA, run by University of Idaho at 1 site in United States.

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Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemiparesis; Poststroke/CVA
What is being tested?
Wearable Shoulder Exoskeleton and Wearable Hand Exoskeleton
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
18 Jun 2024to Aug 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Idaho Integrated Research and Innovation Center

    Moscow, Idaho, 83844

Other trials in United States

About this study

Official title: Improving Arm Function After Stroke Using Synergy-Based Assistance in Wearable Exoskeletons

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?
Read more

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.

Being tested
Wearable Shoulder Exoskeleton, Wearable Hand Exoskeleton
Medical subject headings
Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wearable Shoulder ExoskeletonDevice

    Also called Wearable-S

    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.

  • Wearable Hand ExoskeletonDevice

    Also called Wearable-H

    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.

Study groups in NCT05951491
Study groupRoleWhat they receive
Chronic StrokeExperimentalIndividuals more than 6 months post-stroke in stable condition with long-term impairment affecting the arm and hand.
Receives: Device: Wearable Shoulder Exoskeleton; Device: Wearable Hand Exoskeleton

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

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

Secondary outcomes (2)
  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.

    Measured: 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.

    Measured: up to 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start18 Jun 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951491
Sponsor's protocol ID
23-041
Status last verified
Apr 2026
First submitted
15 Jun 2023
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Wearable Shoulder Exoskeleton and Wearable Hand Exoskeleton in people with Hemiparesis; Poststroke/CVA, run by University of Idaho at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BBT change in score (time frame: Scores with and without exoskeleton assistance are measured during a single session not more than 30 minutes apart.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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