StrokeNCT07218276
Passive Robots for Stroke Rehabilitation: A Feasibility Study
A study testing Functional Training with SepaRRo and NeuRRoFES in people with Stroke, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Training with SepaRRo and NeuRRoFES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 1 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years;
- Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
- No major deficits of sensation or proprioception;
Who cannot join
- Bilateral stroke
- Unable to think clearly and remember (Mini-Mental State Exam score < 22 and miniMOCA < 8);
- Uncontrolled Diabetes or Hypertension;
- Severe limitations of joint range of motion that will lead to inability of testing
- Severe spasticity and joint contractures that will lead to inability of testing
- Complete paresis with no possible movements
Show all 15Show fewer
- Severe aphasia
- Any other medical condition that will significantly impact the study results
- Unable to obtain reliable motor evoked potentials
- Are pregnant or are actively trying to conceive
- Have a recent history of repeated fainting spells or syncope.
- Have a recent history of seizure (epilepsy) while on anti-seizure medication
- Have a recent history of skull fracture/head injury
- Have metal implants in the skull
- Have cardiac pacemakers
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
University of Michigan - NeuRRo Lab
Ann Arbor, Michigan, 48108
Thomas E. Augenstein, PhD, 734-936-4031, tomaugen@umich.edu
Chandramouli Krishnan, PT PhD
About this study
Official title: Passive Robots for Stroke Rehabilitation
The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.
Read the detailed description
About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.
- Conditions
- Stroke
- Being tested
- Functional Training with SepaRRo and NeuRRoFES
- Keywords
- synergy, upper extremity, stroke survivors, robot, hemiparesis, weakness
- Medical subject headings
- Stroke, Paresis, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Training with SepaRRo and NeuRRoFESDevice
Participants will perform functional movements (e.g., reach for targets) with their extremities. During movements, the devices will be used to assist or resist their motion. Participants may receive biofeedback of their movements to better engage them in training. Participants may receive assistance from the devices (including neuromuscular stimulation) and/or their less-impaired limb.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Intervention | Experimental | Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks Receives: Device: Functional Training with SepaRRo and NeuRRoFES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Survey For Feasibility
Subjective feedback regarding feasibility of the device for training
Measured: Post-intervention (immediately following last session of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start5 Nov 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandramouli Krishnan, University of Michigan
- Investigators
- Chandramouli Krishnan, PT, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218276
- Sponsor's protocol ID
- HUM00087962
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Robots for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT07218276
- Acronym / sponsor ID
- HUM00087962
- Conditions
- Stroke
- Keywords
- synergy, upper extremity, stroke survivors, robot, hemiparesis, weakness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Oct 2025 (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 purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.
Detailed description
About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Intervention | Experimental | Device: Functional Training with SepaRRo and NeuRRoFESParticipants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75 years;
- Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
- No major deficits of sensation or proprioception;
Key exclusion criteria (15 listed)
- Bilateral stroke
- Unable to think clearly and remember (Mini-Mental State Exam score < 22 and miniMOCA < 8);
- Uncontrolled Diabetes or Hypertension;
- Severe limitations of joint range of motion that will lead to inability of testing
- Severe spasticity and joint contractures that will lead to inability of testing
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 |
|---|---|---|
| Functional Training with SepaRRo and NeuRRoFESParticipants will perform functional movements (e.g., reach for targets) with their extremities. During movements, the devices will be used to assist or resist their motion. Participants may receive biofeedback of their movements to better engage them in training. Participants may receive assistance from the devices (including neuromuscular stimulation) and/or their less-impaired limb. | Device | Robotic Intervention |
Primary outcome
Device Survey For Feasibility
Time frame: Post-intervention (immediately following last session of intervention)
Subjective feedback regarding feasibility of the device for training
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 10 Nov 2025.
- 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.
Chandramouli Krishnan, PT, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Training with SepaRRo and NeuRRoFES in people with Stroke, run by University of Michigan 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 3 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 10 Nov 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?
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 Chandramouli Krishnan, PT, PhD (7349364031, mouli@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Survey For Feasibility (time frame: Post-intervention (immediately following last session of intervention)). 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 10 Nov 2025.