Passive Robots for Stroke Rehabilitation: A Feasibility Study

Official title

Passive Robots for Stroke Rehabilitation

Overview

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

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.

Interventions

• Device 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 measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 1 center

• University of Michigan - NeuRRo Lab — Ann Arbor

Identifiers

NCT: NCT07218276 · HUM00087962

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗