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Passive Robots for Stroke Rehabilitation: A Feasibility Study

NCT ID: NCT07218276

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke

Keywords

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synergy upper extremity stroke survivors robot hemiparesis weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Robotic Intervention

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

Group Type EXPERIMENTAL

Functional Training with SepaRRo and NeuRRoFES

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Chandramouli Krishnan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chandramouli Krishnan, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan - NeuRRo Lab

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chandramouli Krishnan, PT, PhD

Role: CONTACT

Phone: 7349364031

Email: [email protected]

Thomas E Augenstein, PhD

Role: CONTACT

Phone: 7342320898

Email: [email protected]

Facility Contacts

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Thomas E. Augenstein, PhD

Role: primary

Other Identifiers

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HUM00087962

Identifier Type: -

Identifier Source: org_study_id