Recruiting

Passive Devices & Neuromuscular Stimulation

Sponsor:

University of Michigan

Code:

NCT07218276

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Functional Training with SepaRRo and NeuRRoFES

Study Details

Brief 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.

Conditions

Stroke

Study ID

NCT07218276

Start date

Nov 5, 2025

Status verified date

Nov, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Robotic Intervention

Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks

Interventions

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.

Primary outcome measure

  • Device Survey For Feasibility [ Time Frame: Post-intervention (immediately following last session of intervention) ]

Central Contacts and Locations

Central contacts

Chandramouli Krishnan, PT, PhD

7349364031mouli@umich.edu

Thomas E Augenstein, PhD

7342320898tomaugen@umich.edu

Locations

University of Michigan - NeuRRo Lab

Recruiting

Ann Arbor, Michigan, United States, 48108

Contacts

Thomas E. Augenstein, PhD

734-936-4031tomaugen@umich.edu

Principal Investigator:

Chandramouli Krishnan, PT PhD

More Information

Sponsor

University of Michigan

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-11-10.