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

Purpose

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.

Condition

  • Stroke

Eligibility

Eligible Ages
Between 22 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hybrid multi-muscle FES+Robot 		Participants will be receive hybrid upper extremity training involving the combination of REACH robotic device and multi-muscle FES. Water based electrodes will be positioned on the Triceps, Anconeus, wrist and finger extensors. Stimulation intensity of FES will be set at the participants tolerance level. The FES induced muscle contraction timing will be triggered in synchrony with the robotic movement. The training will be a multi-directional reach movement and hand opening re-training.
  • Combination Product: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group
    Participants in this group will receive multi-muscle FES during arm robotic training
Active Comparator
Robot only 		Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.
  • Combination Product: Robot only group
    Participants in this group will receive arm robotic training only

Recruiting Locations

University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885 21201
Contact:
Sanjana Rao

More Details

Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Sanjana Rao
4438256349
sanjana.rao@som.umaryland.edu

Detailed 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.