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NCT Number: NCT07218276

Passive Robots for Stroke Rehabilitation: A Feasibility Study

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.

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Key information

Conditions

Stroke Asthenia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan - NeuRRo Lab

Ann Arbor, Michigan, 48108, United States

Location status: Recruiting

Location contact

Chandramouli Krishnan, PT PhD

PRINCIPAL_INVESTIGATOR

Thomas E. Augenstein, PhD

CONTACT

[email protected]

734-936-4031

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Training with SepaRRo and NeuRRoFES

Device

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.

Primary outcomes

  1. Device Survey For Feasibility

    Time frame: Post-intervention (immediately following last session of intervention)

    Subjective feedback regarding feasibility of the device for training

Other outcomes

  1. Retention

    Time frame: Post-intervention (immediately following last session of intervention)

    Measure of how many participants completed intervention

  2. Adherence

    Time frame: Post-intervention (immediately following last session of intervention)

    Measure of percentage of sessions completed

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chandramouli Krishnan, PT, PhD

CONTACT

[email protected]

7349364031

Thomas E Augenstein, PhD

CONTACT

[email protected]

7342320898

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Passive Robots for Stroke Rehabilitation

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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