Chronic StrokeNCT05296408
Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
A study testing motor learning based therapy, MyoPro and Home Exercise Program in people with Chronic Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- motor learning based therapy, MyoPro and Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-89 years of age
- Unilateral arm weakness due to stroke (6 months or more since onset)
- Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
- Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
- Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the MyoPro software
- MAS score less or equal to 3 for the biceps, triceps, supinators and pronators of the impaired arm
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- Able to read and comprehend the English language
- Able to follow directions
- Able to provide informed consent
- Medically and psychologically stable.
- Ability to don/doff MyoPro independently or have support as needed.
- Ability to undergo MRI
- Ability to undergo TMS procedures
Who cannot join
- Previous stroke(s) affecting motor function on the opposite side.
- Persistent and severe shoulder subluxation, pain or dislocation
- Shoulder passive range of motion < 45 degrees in flexion and abduction
- Fixed upper limb contractures on the impaired arm and hand
- Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
- Skin rash or open non-healing wound on impaired arm
Show all 15Show fewer
- Involuntary movements of the impaired arm
- Pacemaker or other implanted devices that are not compatible with testing procedures or would interfere with donning/doffing and functioning of device.
- Metal in the skull or deformity of the skull
- Claustrophobia, or inability to operate the MRI patient call button
- Contraindications for MRI (standardized screening form for MRI).
- Past history of seizures
- Family history of medication refractory epilepsy
- Pregnancy or pregnancy planning during the study period
- Currently taking medications or substances that lower the threshold for onset of seizure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Holly B Henry, 216-791-3800 ext. 64657, holly.henry@va.gov
Svetlana Pundik, MD
About this study
This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.
Read the detailed description
Current rehabilitation methods fail to restore normal arm function for many stroke survivors, particularly those with severe deficits. The main objective of this study is to test efficacy and evaluate underlying neurophysiological mechanisms of a novel approach to treat persistent severe arm deficits after stroke with a combination of MyoPro and motor learning-based therapy. The investigators will also estimate cost effectiveness of this therapeutic approach. Rationale: Motor learning-based therapy is one of the most effective stroke rehabilitation methods available, however its application is challenging for individuals with severe arm impairment because of their limited ability to practice volitional arm movement effectively. The MyoPro is an exoskeletal myoelectrically controlled orthotic device that is custom fitted to an individual's paretic arm and assists the user to move the paretic arm. MyoPro can help with motor learning-based therapy for individuals with severe motor deficits as it motivates practice because even weak muscle activity is translated into patient-initiated arm movement. Preliminary results of motor-learning therapy using MyoPro in the investigators' laboratory showed an increase in Fugl-Meyer for Upper extremity score (FM) of 7.4 points following 18 weeks of training (18 in-clinic therapy sessions over 9 weeks followed by 9 weeks of home practice) for chronic stroke survivors with baseline FM 30. However, comparison of the same dose of combination therapy with motor-learning alone remains to be determined. Study Design: Using a randomized, controlled design, individuals with chronic severe stroke ( 6 months post; Fugl Meyer UE score 30;n=60) will participate in either MyoPro+motor learning (M+ML) or motor learning alone (ML-alone). The study intervention will include 9 weeks of in-clinic training (18 sessions;1.5 hours each) followed by 9 weeks of home practice and a 6-week follow-up. Aim 1 is to determine whether M+ML results in greater treatment gains compared to ML-alone. The primary outcome will be change in FM. Secondary outcome measures will assess overall paretic arm performance and will include: kinematics, muscle tone (Modified Ashworth Scale; MAS), grip/pinch/arm dynamometry, sensory function (Semmes Weinstein mono-filament test, joint proprioception), arm function (Arm Motor Ability Test (AMAT);actigraphy) and quality of life (Stroke Impact Scale (SIS)). Aim 2 is to characterize structural and functional brain changes after treatment. Outcomes include corticospinal excitability (motor evoked potential recruitment curve (MEP-rc)), and functional connectivity (resting state function Magnetic Resonance Imaging(rs-fMRI). Aim 3 is to identify baseline factors associated with greater functional improvement with treatment. Outcomes are as follows: baseline integrity of the stroke-affected corticospinal tract (lesion load, MEP-rc; Diffusion Tensor Imaging); baseline motor ability of the affected arm (FM); baseline functional connectivity (rs-fMRI); device usage and actigraphy. Aim 4 is to evaluate cost effectiveness of M+ML versus ML-alone. Outcomes include: direct/indirect costs and health related quality of life surveys (Short Form 12v.2 and SIS). Significance: This study will address an important problem for the VA patient population by testing for the first time whether MyoPro combined with motor learning-based therapy is superior to motor learning alone in the treatment of chronic, severe arm impairment in stroke. If found to be effective, the study intervention is readily deployable to the clinical setting.
- Conditions
- Chronic Stroke
- Being tested
- motor learning based therapy, MyoPro, Home Exercise Program
- Keywords
- stroke, rehabilitation, upper limb, motor learning, cerebrovascular accident
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor learning based therapyBehavioural
Motor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progressed according to a motor control hierarchy to ensure adequate challenge. Training is always started at the appropriate level of challenge for an individual to ensure adequate challenge is delivered whether the individual is higher or lower functioning.
MyoProBehavioural
The MyoPro supports motor learning-based training by reinforcing coordinated movement practice, allowing for finely incrementalized training progression, and encouraging high repetition of movement. Importantly, the device assists the user to move the paretic limb in a manner they may otherwise be unable to do. This further motivates the user to continue attempts to move the paretic limb. When a user attempts to volitionally contract a weak muscle, sensors embedded within the MyoPro detect the EMG signal, which triggers activation of a motor within the device. The motor assists the user to complete the desired movement (e.g. opening of the hand).Subjects experience real-time biofeedback through their ability to sense and see movement of the target joint(s) and via their interface with the software on a computer that provides visual feedback of the EMG level of the contracting muscle
Home Exercise ProgramBehavioural
Every subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals will log practice time. The HEP for M+ML will include practice with and without the MyoPro; the HEP for ML-alone will include practice without MyoPro. Each HEP session will require approximately 90 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| M+ML | Experimental | MyoPro paired with motor learning based therapy Receives: Behavioral: motor learning based therapy; Behavioral: MyoPro; Behavioral: Home Exercise Program |
| ML-alone | Active comparator | motor learning based therapy alone Receives: Behavioral: motor learning based therapy; Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer for Upper Limb (FM) change
Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points) where higher scores represent better arm function.
Measured: weeks 1, 4, 9, 18 and 24
Secondary outcomes (9)
Modified Ashworth Scale (MAS)
MAS will be used to assess muscle tone. Using a 5-point scale, resistance to passive movement about a joint with is scored. MAS has been widely used to quantify muscle tone following stroke. MAS of the shoulder internal rotators, elbow flexors/extensors, forearm pronators/supinators, wrist flexors/extensors and finger flexors/extensors will be scored.
Measured: weeks 1, 4, 9, 18, 24
Upper limb kinematics
The investigators will use a 3-D optic motion analysis (Vicon) system to assess participants' movement performance during supported forward reach and a forward reach to grasping task. Kinematic variables to be assessed will include joint range of motion used to perform the task and end-point trajectory.
Measured: weeks 1, 4, 9, 18, 24
Dynamometry
Muscle force production of the elbow flexors/extensors and wrist flexors/extensors will be assessed using standardized hand-held dynamometry.
Measured: weeks 1, 4, 9, 18, 24
Arm Motor Ability Test
AMAT tests the time and quality of performance of 13 different complex tasks of activities of daily living (ADL). Rating is based on the quality of movement, ability to complete the task and time elapsed.
Measured: weeks 1, 4, 9, 18, 24
Stroke Impact Scale
The SIS is a self-report measure that evaluates disability and health related quality of life across 8 domains for individuals with stroke.
Measured: weeks 1, 4, 9, 18, 24
Transcranial Magnetic Stimulation (TMS)
motor evoked potentials will be recorded at stimulator output (SO) intensities ranging from those that evoke no response above baseline activity to those that evoke a maximal response. SO will be increased until the MEP amplitude plateaus, or the maximum SO (100%) is reached.
Measured: weeks 1, 4, 9, 18, 24
Brain network connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI)
Functional connectivity within the Sensory Motor network (SMN) and Default Mode Network (DMN) will be computed based on resting state functional Magnetic Resonance Imaging (rs-fMRI). SMN and DMN network connectivity matrices will be computed using anatomical regions defined in the automated anatomical labelling (AAL) atlas. The mean time course from each region will be extracted and Pearson correlation will be computed.
Measured: week 1 and 18
Short Form 12v12
SF 12v12 is a self report questionnaire that measures health related quality of life.
Measured: weeks 1, 9, 18, 24
Fractional anisotropy of movement-related tracts
FA will computed for bilateral motor output tracts by fitting a tensor model at each voxel and then be assessed within the non-lesion portion of a white matter tract.
Measured: week 1 and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomized to either receive motor learning combined with Myopro (M+ML) or motor learning alone (ML-alone)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Svetlana Pundik, MD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296408
- Sponsor's protocol ID
- N3674-R
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton Research: Myoelectric Orthosis for Rehab of Severe Chronic Arm Motor Deficits
- ClinicalTrials.gov ID
- NCT05296408
- Acronym / sponsor ID
- N3674-R
- Conditions
- Chronic Stroke
- Keywords
- stroke, rehabilitation, upper limb, motor learning, cerebrovascular accident
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Mar 2022 (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.
This study will evaluate the effects of combining motor learning-based therapy with use of the MyoPro , a wearable exoskeletal myoelectrically controlled orthotic device. MyoPro uses electromyographic (EMG) signals from the weak muscles to assist movement of the user's affected arm. The primary objective of this randomized controlled trial is to study the efficacy of using MyoPro in motor learning-based therapy for individuals with chronic stroke (>6 months post) with severe upper limb motor deficits (Fugl-Meyer for Upper Limb score less than 30) compared with a similar dose of motor learning-based therapy alone. The secondary objectives are to evaluate neuroplasticity mechanisms, identify biomarkers of greater response to the intervention, and explore cost-effectiveness.
Detailed description
Current rehabilitation methods fail to restore normal arm function for many stroke survivors, particularly those with severe deficits. The main objective of this study is to test efficacy and evaluate underlying neurophysiological mechanisms of a novel approach to treat persistent severe arm deficits after stroke with a combination of MyoPro and motor learning-based therapy. The investigators will also estimate cost effectiveness of this therapeutic approach. Rationale: Motor learning-based therapy is one of the most effective stroke rehabilitation methods available, however its application is challenging for individuals with severe arm impairment because of their limited ability to practice volitional arm movement effectively. The MyoPro is an exoskeletal myoelectrically controlled orthotic device that is custom fitted to an individual's paretic arm and assists the user to move the paretic arm. MyoPro can help with motor learning-based therapy for individuals with severe motor deficits as it motivates practice because even weak muscle activity is translated into patient-initiated arm movement. Preliminary results of motor-learning therapy using MyoPro in the investigators' laboratory showed an increase in Fugl-Meyer for Upper extremity score (FM) of 7.4 points following 18 weeks of training (18 in-clinic therapy sessions over 9 weeks followed by 9 weeks of home practice) for chronic stroke survivors with baseline FM 30. However, comparison of the same dose of combination therapy with motor-learning alone remains to be determined. Study Design: Using a randomized, controlled design, individuals with chronic severe stroke ( 6 months post; Fugl Meyer UE score 30;n=60) will participate in either MyoPro+motor learning (M+ML) or motor learning alone (ML-alone). The study intervention will include 9 weeks of in-clinic training (18 sessions;1.5 hours each) followed by 9 weeks of home practice and a 6-week follow-up. Aim 1 is to determine whether M+ML results in greater treatment gains compared to ML-alone. The primary outcome will be change in FM. Secondary outcome measures will assess overall paretic arm performance and will include: kinematics, muscle tone (Modified Ashworth Scale; MAS), grip/pinch/arm dynamometry, sensory function (Semmes Weinstein mono-filament test, joint proprioception), arm function (Arm Motor Ability Test (AMAT);actigraphy) and quality of life (Stroke Impact Scale (SIS)). Aim 2 is to characterize structural and functional brain changes after treatment. Outcomes include corticospinal excitability (motor evoked potential recruitment curve (MEP-rc)), and functional connectivity (resting state function Magnetic Resonance Imaging(rs-fMRI). Aim 3 is to identify baseline factors associated with greater functional improvement with treatment. Outcomes are as follows: baseline integrity of the stroke-affected corticospinal tract (lesion load, MEP-rc; Diffusion Tensor Imaging); baseline motor ability of the affected arm (FM); baseline functional connectivity (rs-fMRI); device usage and actigraphy. Aim 4 is to evaluate cost effectiveness of M+ML versus ML-alone. Outcomes include: direct/indirect costs and health related quality of life surveys (Short Form 12v.2 and SIS). Significance: This study will address an important problem for the VA patient population by testing for the first time whether MyoPro combined with motor learning-based therapy is superior to motor learning alone in the treatment of chronic, severe arm impairment in stroke. If found to be effective, the study intervention is readily deployable to the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be randomized to either receive motor learning combined with Myopro (M+ML) or motor learning alone (ML-alone)
| Arm | Type | Receives |
|---|---|---|
| M+ML | Experimental | Behavioral: motor learning based therapy, Behavioral: MyoPro, Behavioral: Home Exercise ProgramMyoPro paired with motor learning based therapy |
| ML-alone | Active comparator | Behavioral: motor learning based therapy, Behavioral: Home Exercise Programmotor learning based therapy alone |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18-89 years of age
- Unilateral arm weakness due to stroke (6 months or more since onset)
- Adequate range of motion at the elbow, forearm, wrist, and hand to don the device
- Active shoulder flexion of at least 30 degrees and active shoulder abduction of at least 20 degrees
- Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the MyoPro software
Key exclusion criteria (15 listed)
- Previous stroke(s) affecting motor function on the opposite side.
- Persistent and severe shoulder subluxation, pain or dislocation
- Shoulder passive range of motion < 45 degrees in flexion and abduction
- Fixed upper limb contractures on the impaired arm and hand
- Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
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 |
|---|---|---|
| motor learning based therapyMotor learning based therapy will include functional task/task component training and will be employed to practice hand-to-mouth, forward reach, grasp-release, and object manipulation. Training will include high repetition both in the clinic and during home exercise practice. Tasks will be decomposed into component parts and practiced in this manner with the goal of returning to full task performance as skill develops Training will be tailored to each individual subject's capability and progressed according to a motor control hierarchy to ensure adequate challenge. Training is always started at the appropriate level of challenge for an individual to ensure adequate challenge is delivered whether the individual is higher or lower functioning. | Behavioural | M+ML, ML-alone |
| MyoProThe MyoPro supports motor learning-based training by reinforcing coordinated movement practice, allowing for finely incrementalized training progression, and encouraging high repetition of movement. Importantly, the device assists the user to move the paretic limb in a manner they may otherwise be unable to do. This further motivates the user to continue attempts to move the paretic limb. When a user attempts to volitionally contract a weak muscle, sensors embedded within the MyoPro detect the EMG signal, which triggers activation of a motor within the device. The motor assists the user to complete the desired movement (e.g. opening of the hand).Subjects experience real-time biofeedback through their ability to sense and see movement of the target joint(s) and via their interface with the software on a computer that provides visual feedback of the EMG level of the contracting muscle | Behavioural | M+ML |
| Home Exercise ProgramEvery subject will be assigned an individualized HEP. Therapy staff will create written handouts for the user to follow. The HEP will include photographs of the study participant performing his/her exercises/functional tasks along with written instructions. Each individual will have their own personalized HEP that will be created during their study participation and will be dispensed only to them. The HEP will reinforce in-clinic therapy. The HEP will be progressed regularly, and individuals will log practice time. The HEP for M+ML will include practice with and without the MyoPro; the HEP for ML-alone will include practice without MyoPro. Each HEP session will require approximately 90 minutes to complete. | Behavioural | M+ML, ML-alone |
Primary outcome
Fugl Meyer for Upper Limb (FM) change
Time frame: weeks 1, 4, 9, 18 and 24
Thirty-three items of movement coordination and reflex activity are scored with a 3-point Likert scale (0-66 points) where higher scores represent better arm function.
9 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: weeks 1, 4, 9, 18, 24
Upper limb kinematics
Time frame: weeks 1, 4, 9, 18, 24
Dynamometry
Time frame: weeks 1, 4, 9, 18, 24
Arm Motor Ability Test
Time frame: weeks 1, 4, 9, 18, 24
Stroke Impact Scale
Time frame: weeks 1, 4, 9, 18, 24
Transcranial Magnetic Stimulation (TMS)
Time frame: weeks 1, 4, 9, 18, 24
Brain network connectivity using resting state functional Magnetic Resonance Imaging (rs-fMRI)
Time frame: week 1 and 18
Short Form 12v12
Time frame: weeks 1, 9, 18, 24
Fractional anisotropy of movement-related tracts
Time frame: week 1 and 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Svetlana Pundik, MD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor learning based therapy, MyoPro and Home Exercise Program in people with Chronic 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 13 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 21 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica P McCabe, MPT DPT ((216) 791-3800 ext. 4691, Jessica.Mccabe@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer for Upper Limb (FM) change (time frame: weeks 1, 4, 9, 18 and 24). 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 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.