NCT07218276

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable stroke

Timeline
16mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Nov 2025Oct 2027

First Submitted

Initial submission to the registry

October 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

November 5, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

October 15, 2025

Last Update Submit

November 5, 2025

Conditions

Stroke

Keywords

synergyupper extremitystroke survivorsrobothemiparesisweakness

Outcome Measures

Primary Outcomes (1)

  • Device Survey For Feasibility

    Subjective feedback regarding feasibility of the device for training

    Post-intervention (immediately following last session of intervention)

Other Outcomes (12)

  • Retention

    Post-intervention (immediately following last session of intervention)

  • Adherence

    Post-intervention (immediately following last session of intervention)

  • Upper extremity Fugl-Meyer Score

    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 more other outcomes

Study Arms (1)

Robotic Intervention

EXPERIMENTAL

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

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.

Robotic Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan - NeuRRo Lab

Ann Arbor, Michigan, 48108, United States

RECRUITING

MeSH Terms

Conditions

StrokeParesisAsthenia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chandramouli Krishnan, PT, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandramouli Krishnan, PT, PhD

CONTACT

7349364031mouli@umich.edu

Thomas E Augenstein, PhD

CONTACT

7342320898tomaugen@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2025

First Posted

October 20, 2025

Study Start

November 5, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)