Skip to main content
OpenTrials
Completed

NCT Number: NCT05854485

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with chronic stroke(>6months post stroke)
  • Age-22-85 years old
  • Ability to perform a Upper Extremity forward reach of about 3 inches

Exclusion criteria

  • Upper Extremity co-morbidities-pain, arthritis, and other neurological disorders
  • Unable to tolerate electrical stimulation
  • Have implants such as pacemaker, spinal cord or deep brain stimulator
  • Have an elbow contracture of greater than 150 degrees
  • Receiving Botox injections within 3 months

Treatment and study plan

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

Combination Product

Participants in this group will receive multi-muscle FES during arm robotic training

Robot only group

Combination Product

Participants in this group will receive arm robotic training only

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 11, 2023
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.