Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation

The research purpose is to investigate the feasibility of using a motor-cable-driven system for wrist and forearm recovery of hemiplegic subjects suffered from stroke, where assistive force would be generated from cables connected to pulleys and electrical motors. The system may use EMG signal to control the movements.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Motor-cable-driven Rehabilitation Robotic System

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Kai-yu Tong; Phone Number: +85239438454; Email: kytong@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Biomedical Engineering, The Chinese University of Hong Kong
    • Contact: Raymond Tong, PhD; Phone Number: +852 3943 8454

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sub-acute and chronic stroke patients (ischemic or hemorrhagic).
• Sufficient cognition to follow simple instructions as well as understand the content and purpose of the study.

Exclusion criteria:

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication.
2. Any additional medical or psychological condition affecting their ability to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: motor-cable-driven system; Receive motor-cable-driven system	Device: Motor-cable-driven Rehabilitation Robotic System; Subjects will wear the motor-cable-driven system and receive 30 minutes (including preparation time) wrist and forearm robot-assisting exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forearm's Assisted Range of Motion	Forearm's assisted range of motion is a measurement to identify how far the person's joints range can move in pronation-supination assisted by the motor-cable-driven system. The moving range will be recorded by the system and stored in computer	Baseline
Wrist's Assisted Range of Motion	Wrist's Assisted range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation with the assistance of motor-cable-driven system. The moving range will be recorded by the system and stored in computer.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper limb Fugl-Meyer Assessment (FMA)	Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.	Baseline
Motor Assessment Scale (MAS)	Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement. Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.	Baseline
Modified Ashworth Scale	Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale. Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed. Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch.	Baseline
Forearm's Active Range of Movement	Forearm's active range of motion is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort. The moving range will be recorded by the system and stored in computer.	Baseline
Forearm's Passive Range of Motion	Forearm's passive range of motion is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually. The moving range will be recorded by the system and stored in computer.	Baseline
Wrist's active range of motion	Wrist's active range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation by moving with their own effort. The moving range will be recorded by the system and stored in computer.	Baseline
Wrist's Passive Range of Motion	Wrist's passive range of motion is a measurement to identify how far the person's joints range can move in flexion/extension, and radial deviation/ulnar deviation directed by a person manually. The moving range will be recorded by the system and stored in computer.	Baseline

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Raymond Kai-yu Tong, Department of Biomedical Engineering, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2023.166

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No