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

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Stroke

Treatments: Combination Product: REACH robotic training and multi-muscle Functional Electrical Stimulation (FES) group; Combination Product: Robot only group

Study type: Interventional

Funder types: Other

Identifiers

NCT05854485

HP-00105650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Hybrid multi-muscle FES+Robot

Experimental group

Description:

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.

Treatment:

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

Robot only

Active Comparator group

Description:

Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.

Treatment:

Combination Product: Robot only group