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

December 16, 2025 updated by: Kelly Westlake, University of Maryland, Baltimore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematic Assessment:Smoothness in 1/s2
Time Frame: Change from Baseline Smoothness at 6 weeks
This measure will be collected as the participants performs target reaching out and in movements of the arm. Smoothness will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.
Change from Baseline Smoothness at 6 weeks
Kinematic Assessment:Speed in cm/seconds
Time Frame: Change from Baseline Speed at 6 weeks
This measure will be collected as the participants performs target reaching out and in movements of the arm. Speed will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.
Change from Baseline Speed at 6 weeks
Kinematic Assessment:Range of Motion(ROM) in cms
Time Frame: Change from Baseline ROM at 6 weeks
This measure will be collected as the participants performs target reaching out and in movements of the arm. ROM will be collected from the REACH robotic device to determine the kinematic changes in the reaching movements. Kinereach/trakStar system will also be utilized to conduct kinematic assessment and determine the translation of training effects into functional upper extremity use.
Change from Baseline ROM at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Upper Extremity(FMA-UE)
Time Frame: Change from Baseline FMA-UE at 6 weeks
FMA-UE is a standard measure for the clinical assessment of motor impairment. FMA mainly evaluates the degree of synergy pattern during volitional movements, along with reflex activity and coordination. It is based on 33 items and scores range from 0 to 66. A higher score means better motor function.
Change from Baseline FMA-UE at 6 weeks
Modified Ashworth Scale of muscle spasticity (MAS)
Time Frame: Change from Baseline MAS at 6 weeks
The MAS is a measurement of spasticity across specific muscle groups. The grading of spasticity ranges from 0 to 5 with higher score indicating worse functioning.
Change from Baseline MAS at 6 weeks
Wolf Motor Function Test (WMFT)
Time Frame: Change from Baseline WMFT at 6 weeks
WMFT is a function based test designed to measure upper extremity movements and movement speed during functional tasks. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks and 2 strength-based tasks. Two types of scores are recorded during the task:WMFT-TIME(time of the task) and WMFT-FAS (functional abilities). The maximum score of WMFT-TIME is 120 seconds, and a higher score means slower movement. WMFT-FAS is scored from 0 to 5, and a higher score indicates higher level of functional performance, better quality of the paretic upper extremity during the task.
Change from Baseline WMFT at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2023

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00105650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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