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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062121
• Other study ID #: 2023.166
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: Raymond Kai-yu Tong
• Phone: +85239438454
• Email: kytong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Biomedical Engineering, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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