Passive Robots for Stroke Rehabilitation: A Feasibility Study

November 5, 2025 updated by: Chandramouli Krishnan, University of Michigan

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chandramouli Krishnan, PT, PhD
  • Phone Number: 7349364031
  • Email: mouli@umich.edu

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • Recruiting
        • University of Michigan - NeuRRo Lab
        • Contact:
        • Principal Investigator:
          • Chandramouli Krishnan, PT PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 to 75 years;
  • Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
  • No major deficits of sensation or proprioception;

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Robotic Intervention
Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks
Device: Functional Training with SepaRRo and NeuRRoFES
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device Survey For Feasibility
Time Frame: Post-intervention (immediately following last session of intervention)
Subjective feedback regarding feasibility of the device for training
Post-intervention (immediately following last session of intervention)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: Post-intervention (immediately following last session of intervention)
Measure of how many participants completed intervention
Post-intervention (immediately following last session of intervention)
Adherence
Time Frame: Post-intervention (immediately following last session of intervention)
Measure of percentage of sessions completed
Post-intervention (immediately following last session of intervention)
Upper extremity Fugl-Meyer Score
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.
Changes in upper extremity Fugl-Meyer score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Fugl-Meyer score is a measure of functional impairment and runs from 0 to 66 points, with higher numbers reflecting better outcome.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.
Reachable workspace
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in reachable workspace from before the intervention (from baseline) to after its completion). The reachable workspace area will be measured with SepaRRo obtained from optical encoders mounted in the device.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Voluntary hand opening
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in voluntary ability to open the hand from before the intervention (from baseline to after its completion). Voluntary hand opening will be measured with motion capture equipment.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Action Research Arm Test Score
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in the Action Research Arm Test Score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Action Research Arm Test is a measure of arm functional ability and runs from 0 to 57 points, with higher numbers reflecting better outcome.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Box and Block (BBT)
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in functional measure of arm disability (BBT) from before the intervention (from baseline) to after its completion using publicly available scoring sheets.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Hand Strength
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in force produced by the hand from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Arm strength
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in force produced by the arm from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Muscle coordination
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in muscle coordination of the upper extremity muscles as measured using surface electromyography between before the intervention (from baseline) to after its completion.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Joint coordination
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in coordination of the upper extremity joints as measured motion capture between before the intervention (from baseline) to after its completion.
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Corticospinal excitability
Time Frame: Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
Changes in corticospinal excitability of the upper extremity muscles as measured using surface electromyography and transcranial magnetic stimulation between before the intervention (from baseline) to after its completion
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chandramouli Krishnan, PT, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00087962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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