ClinicalTrials.gg
RecruitingNCT07218276Updated Nov 10, 2026

Passive Robots for Stroke Rehabilitation: A Feasibility Study

An interventional study of Functional Training with SepaRRo and NeuRRoFES in Stroke, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by University of Michigan · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Stroke by University of Michigan — 3 open to participants now, 3 under way, none of them phase 3. Stroke · University of Michigan.

Planned enrollment
21st of 21
4 · median 40
Started
2025
the only one that year
No phase
19 of 22
3 open now
Registered
20th of 22
by date

Among the 22 studies in Stroke by University of Michigan, this one is the 21st largest by planned enrollment of the 21 interventional ones, is the only one that started in 2025, is one of 19 with no phase, and was the 20th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

No phasethis study19 · 3 open
Phase 22 · 0 open
Observational1 · 0 open

By the year they started

First in 2004; this study’s year is marked. 1 started in 2025.

Size and results

Median enrollment 40 across the 21 interventional studies, 34 across the 1 observational. Of the 19 that completed or were terminated, 12 (63%) have results posted.

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02

Study 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 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.

03

Conditions studied

  • Stroke

Keywords

  • synergy
  • upper extremity
  • stroke survivors
  • robot
  • hemiparesis
  • weakness
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Bilateral stroke
  • Unable to think clearly and remember ( 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceFunctional 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.

06

What researchers measure

Primary outcomes

  1. Device Survey For Feasibility

    Subjective feedback regarding feasibility of the device for training

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

Other outcomes

  1. Retention

    Measure of how many participants completed intervention

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

  2. Adherence

    Measure of percentage of sessions completed

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

  3. Upper extremity Fugl-Meyer Score

    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.

    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.

  4. Reachable workspace

    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.

    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

  5. Voluntary hand opening

    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.

    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

  6. Action Research Arm Test Score

    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.

    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

  7. Box and Block (BBT)

    Changes in functional measure of arm disability (BBT) from before the intervention (from baseline) to after its completion using publicly available scoring sheets.

    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

  8. Hand Strength

    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

    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

  9. Arm strength

    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

    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

  10. Muscle coordination

    Changes in muscle coordination of the upper extremity muscles as measured using surface electromyography between before the intervention (from baseline) to after its completion.

    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

  11. Joint coordination

    Changes in coordination of the upper extremity joints as measured motion capture between before the intervention (from baseline) to after its completion.

    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

  12. Corticospinal excitability

    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

    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

07

Study locations

1 of 1 sites recruiting
  • University of Michigan - NeuRRo Lab
    Ann Arbor, Michigan 48108, United States
    Recruiting
    • Thomas E. Augenstein, PhD · Contacttomaugen@umich.edu · (734) 936-4031
    • Chandramouli Krishnan, PT PhD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Oct 2027, 22 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 22 months is close to that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2025
First posted
Oct 20, 2025
StartActual
Nov 5, 2025
Primary completionEst.
Oct 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and contact details
1 update, last Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Minor edits only
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07218276
Responsible party
Chandramouli Krishnan (Principal Investigator, University of Michigan) — Principal investigator
First posted
Oct 20, 2025
Start date
Nov 5, 2025
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Chandramouli Krishnan, PT, PhD
Contact
mouli@umich.edu
7349364031
Thomas E Augenstein, PhD
Contact
tomaugen@umich.edu
7342320898
Chandramouli Krishnan, PT, PhD
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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