Skip to main content
Clinical Trials/NCT05854485
NCT05854485
Completed
N/A

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

University of Maryland, Baltimore1 site in 1 country24 target enrollmentSeptember 6, 2023
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Maryland, Baltimore
Enrollment
24
Locations
1
Primary Endpoint
Kinematic Assessment:Smoothness in 1/s2
Status
Completed
Last Updated
4 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 6, 2023
End Date
June 30, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Westlake

Associate Professor

University of Maryland, Baltimore

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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

  • Modified Ashworth Scale of muscle spasticity (MAS)(Change from Baseline MAS at 6 weeks)
  • Wolf Motor Function Test (WMFT)(Change from Baseline WMFT at 6 weeks)
  • Fugl-Meyer Upper Extremity(FMA-UE)(Change from Baseline FMA-UE at 6 weeks)

Study Sites (1)

Loading locations...

Similar Trials