Interactive Intention-Driven Upper-Limb Training Robotic System

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Hand and Arm Robotic Training; Device: Hand Robotic Training; Other: Conventional therapy

• Registration Number: NCT02077439
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.

Detailed Description

This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.

Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.

There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-04
• Primary Completion: 2015-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

Exclusion Criteria

• Excessive spasticity of the affected arm
• Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand and Arm Robotic Training	Hand and Arm Robotic Training	Hand and Arm Robotic Training
Hand Robotic Training	Hand Robotic Training	Hand Robotic Training
Conventional therapy	Conventional therapy	Conventional therapy

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test	Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months	Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.; Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Fugl-Meyer Assessment	Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months	Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months.; Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.

Secondary Outcome Measures

Name	Time	Method
modified Ashworth Scale	Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months	Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.; Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Wolf Motor Function Test	Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months	Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.; Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.

Trial Locations

Locations (1)

The Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong