Interactive Intention-Driven Upper-Limb Training Robotic System

Stroke Clinical Trial

Official title:

Trial: Interactive Intention-Driven Upper-Limb Training Robotic System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077439
• Other study ID #: ITT/004/12GP
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: February 23, 2017
• Start date: January 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Hand Robotic Training
Training for 20 sessions for one hour, 3-5 times per week.
• Hand and Arm Robotic Training
Training for 20 sessions for one hour, 3-5 times per week.

Other:
• Conventional therapy
Training for 20 sessions for one hour, 3-5 times per week.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment	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.	Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
Primary	Action Research Arm Test	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.	Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
Secondary	Wolf Motor Function Test	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.	Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
Secondary	modified Ashworth Scale	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.	Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months

External Links

•   The Hong Kong Polytechnic University