Passive Robots for Stroke Rehabilitation: A Feasibility Study

University of Michigan

Status

Enrolling

Conditions

Stroke

Treatments

Device: Functional Training with SepaRRo and NeuRRoFES

Study type

Interventional

Funder types

Other

Identifiers

NCT07218276

HUM00087962

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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