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.
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
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.
- Conditions
- Hemiparesis; Poststroke/CVA
- 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 group | Role | What they receive |
|---|---|---|
| Chronic Stroke | Experimental | Individuals 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.
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.
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)
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
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.
- First posted19 Jul 2023
- Study start18 Jun 2024
- Primary completionMay 2027 (estimated)
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis; Poststroke/CVAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Joel Perry, University of Idaho
- Investigators
- Joel C Perry, PhD, Principal investigator, University of Idaho
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Arm Function After Stroke Using Synergy-Based Assistance in Wearable Exoskeletons
- ClinicalTrials.gov ID
- NCT05951491
- Acronym / sponsor ID
- 23-041
- Conditions
- Hemiparesis; Poststroke/CVA
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chronic Stroke | Experimental | Device: Wearable Shoulder Exoskeleton, Device: Wearable Hand ExoskeletonIndividuals more than 6 months post-stroke in stable condition with long-term impairment affecting the arm and hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- currently pregnant
- under 18
- incarcerated
- severe pain with arm or hand movement
- inability to understand verbal or visual instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Shoulder ExoskeletonAlso: Wearable-SThe 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. | Device | Chronic Stroke |
| Wearable Hand ExoskeletonAlso: Wearable-HThe 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 | Chronic Stroke |
Primary outcome
BBT change in score
Time frame: Scores with and without exoskeleton assistance are measured during a single session not more than 30 minutes apart.
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
ARAT change in score
Time frame: Scores with and without exoskeleton assistance are measured during a single session not more than 30 minutes apart.
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
2 secondary outcomes
Unassisted Arm Use at Home (without device)
Time frame: up to 5 days
Unassisted Arm Use at Home (with device)
Time frame: up to 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel C Perry, PhD principal investigator
University of Idaho
1 site in 1 country: see every site and its status.
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.