Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke

Last updated: September 23, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

Robot only group

REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group

Clinical Study ID

NCT05854485
HP-00105650
  • Ages 22-85
  • All Genders

Study Summary

The purpose of this clinical trial is to investigate the efficacy of a hybrid-based rehabilitation program for the upper extremity(UE) combining the interventions- Functional Electrical Stimulation (FES) and Robotic rehabilitation in individuals with chronic stroke. The main question it aims to answer is if the Hybrid multi-muscle FES+Robot upper extremity rehabilitation is more effective in improving the upper extremity motor impairments and function as compared to robotic upper extremity training alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Individuals with chronic stroke(>6months post stroke)

  2. Age-22-85 years old

  3. Ability to perform a Upper Extremity forward reach of about 3 inches

Exclusion

Exclusion Criteria:

  1. Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders

  2. Unable to tolerate electrical stimulation

  3. Have implants such as pacemaker, spinal cord or deep brain stimulator

  4. Have an elbow contracture of greater than 150 degrees

  5. Receiving Botox injections within 3 months

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Robot only group
Phase:
Study Start date:
September 06, 2023
Estimated Completion Date:
June 30, 2025

Study Description

Individuals with chronic stroke(> 6months after stroke) will be recruited. All participants will complete clinical and kinematic assessments at 2 time points(baseline and after 6 weeks training). Each participant will receive 18 sessions of 60 minute upper extremity training over 6 weeks.

Study participants will be randomly assigned to receive either of the following upper extremity training- 1. Hybrid multi-muscle FES+Robot training group or 2.Robot only training group.

The following clinical assessments to measure the motor impairments and functional recovery will be performed: Fugl-Meyer Upper Extremity, Modified Ashworth Scale, and Wolf Motor Function Test.

Kinematic assessments will be conducted using the REACH robotic device and the Kinereach/trakStar system. The following kinematic parameters will be collected: Smoothness, Range of Motion, and Speed.

Connect with a study center

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.