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Acute StrokeNCT05962697

An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors

A study of Acute Stroke, run by VA Office of Research and Development at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Stroke is the leading cause of adult-onset disability, and affects 15,000 Veterans each year. Successful rehabilitation and recovery following a stroke requires therapy including repetitive task training. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acute Stroke
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
3 Aug 2024to 12 Aug 2025
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • over the age of 18 years,
  • have a Fugl-Meyer Upper Extremity score of 29-42 for moderately impaired (aim 1) or 0-28 for severely impaired (aim 1 and 2),
  • have body dimensions within the limits of the Harmony system
  • suffered a stroke within the past 1-6 months (aim 1) or 1 week (aim 2)

Who cannot join

  • recurrent stroke,
  • unstable cardiovascular, orthopedic, or neurological conditions,
  • a history of seizure,
  • significant communication deficits,
  • severe upper-limb joint pain or limitations that would restrict their ability to complete the protocols,
  • inadequate cognitive or language function to consent or to participate, and (7) no phone number or stable mailing address.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

Other trials in United States

About this study

Official title: Developing and Determining Feasibility of a Novel Upper Extremity Robotic Exoskeleton to Track and Target Unwanted Joint Synergies During Repetitive Task Training in Stroke Survivors

Stroke is the leading cause of adult-onset disability, and affects 15,000 Veterans each year. Successful rehabilitation and recovery following a stroke requires therapy including repetitive task training. However, repetitive task training can be draining for both the clinician and the patient as it requires the participant to complete many repetitions of the same task and those repetitions can be difficult to accomplish with appropriate technique. Robot-mediated repetitive task training has the potential to facilitate the clinical delivery of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been developed, called Harmony, which can deliver bimanual 3D arm therapy. The investigators propose to develop and test two novel controllers', synergy avoidance and task assistance, that use promising neurological basis for training to facilitate repetitive task training while ensuring correct movement patterns in acute and sub-acute stage stroke patients. This has the potential to improve Veterans' activities of daily living and quality of life.

Read the detailed description

Stroke causes significant long-term disability and the incidence of stroke in Veteran population is high with approximately 6,000 VA admissions for acute ischemic stroke per year in 2014. Rehabilitation programs that improve upper extremity function have the potential to impact Veterans' activities of daily living and improve their vocation, recreation, and overall quality of life. Repetitive task training (RTT) is active practice of a task-specific motor activity and is more effective than simple joint movements in improving upper extremity function after treatment. However, RTT can be draining for both the clinician and the patient as it requires the participant to complete many repetitions of the same task and those repetitions can be difficult to accomplish with appropriate technique. Previous research has shown that to significantly affect patient recovery it is critical to initiate RTT in the acute and sub-acute stages, maintain health joint coordination, and keep the patients engaged and challenged. Robot-mediated RTT has the potential to facilitate the clinical delivery of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been developed, called Harmony, with the ability to deliver bimanual 3D arm therapy. Currently there a lack of tools for delivering RTT in the early stages of recovery while maintaining joint coordination during 3D arm movement and ensuring that assistance commensurate with patient abilities. Therefore, the objective of this project is to develop novel controllers that use promising neurological basis for training to facilitate repetitive task training while ensuring correct movement patterns in acute and sub-acute stage stroke patients. Specifically, (1) synergy avoidance (SA) controller will apply joint torques to push the patients away from the maladaptive joint coordination, only interfering with the movements once the subject initiates such a maladaptive movement strategy. (2) Task assistance (TA) controller will apply assistive joint torques to directly help stroke patients achieve 3D RTT activities with correct coordination at a high intensity (repetitions/session). Aim 1: to develop and determine feasibility of RTT controller. H1: SA and TA controllers are feasible, as seen by (1) patient safety and (2) abilities of TA and SA controllers to move upper-body joints along task trajectories and away from synergistic coordination, respectively. Up to five sub-acute stroke survivors will complete RTT activities with both the SA and TA controllers. H1 will be considered supported if the applied torque meets the requirements defined by the control law and the feasibility criteria are met for the TA and SA controllers in two consecutive patients. Aim 2: determine feasibility of controllers and quantify change in joint coordination during 3-week intervention. H2a: a 3-week long intervention is feasible with both the controllers as seen by (1) patient safety and (2) abilities for TA and SA controllers to move the upper-body joints toward the desired trajectories for 3D RTT activities while avoiding synergistic compensatory coordination. H2b: the robotic system will accurately track joint synergies in acute stroke patients before and after a 3-week intervention, revealing any change in compensatory strategies. Two acute stroke survivors will be recruited. Participants will be assigned to either the TA or SA controller and will complete high repetitions of reaching tasks once per day while wearing the Harmony exoskeleton for three weeks. Joint kinematic and kinetic data will be recorded by the robotic system in all the sessions. Kinematic data will also be recorded in the evaluation sessions before and after the 3-week intervention in two modalities: robot in zero-torque mode and using an infrared motion tracking system. Joint synergies will be evaluated for the two acute stroke patients before and after a three-week intervention. Hypotheses will be considered supported if there is an acceptably low rate of error between the kinematic measurements of the robotic system and the motion capture system. New rehabilitation programs that improve upper extremity functional performance have the potential to impact Veterans' ADL and improve their vocation, recreation, and overall quality of life. New rehabilitation programs that improve upper extremity function have the potential to impact Veterans' ADLs and improve their vocation, recreation, and overall quality of life.

Conditions
Acute Stroke
Being tested
SA controller, TA controller, SA controller early testing
Keywords
Stroke, Exoskeleton, upper extremity, robot, rehabilitation, joint synergy, controller, feasibility
Medical subject headings
Stroke

What participants receive

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

  • SA controllerOther

    Also called Synergy assistance

    Novel controller to be tested

  • TA controllerOther

    Also called Task assistance

    original controller to be tested

  • SA controller early testingOther

    Also called Synergy assistance early testing

    Novel controller to be tested early testing

Study groups in NCT05962697
Study groupRoleWhat they receive
SA controllerExperimentalSynergy assistance controller
Receives: Other: SA controller; Other: TA controller
early testingOtherup to 5 participants testing the SA controller in one visit
Receives: Other: SA controller early testing

What is being measured

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

  1. Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks

    Clinical measure of upper extremity function Range 0 to 66 - 0 is impaired, 66 is unimpaired

    Measured: 3 weeks

  2. Change from Baseline Action Research Arm Test (ARAT) at 3 weeks

    Clinical measure of upper extremity function Range 0 to 57 0 is impaired, 57 is unimpaired

    Measured: 3 weeks

Timeline

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

  1. First posted27 Jul 2023
  2. Study start3 Aug 2024
  3. Primary completion1 Jul 2025
  4. Study completion12 Aug 2025

Why it stopped: Issues with device development

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05962697
Sponsor's protocol ID
A4631-P
Other IDs
RZ004631
Status last verified
Aug 2025
First submitted
10 Jul 2023
Last updated
20 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Acute Stroke, run by VA Office of Research and Development 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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 20 Aug 2025. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks (time frame: 3 weeks). 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 20 Aug 2025.

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