Interactive Intention-Driven Upper-Limb Training Robotic System

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stroke

Treatments: Device: Hand and Arm Robotic Training; Other: Conventional therapy; Device: Hand Robotic Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02077439

ITT/004/12GP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 3 patient groups

Hand Robotic Training

Experimental group

Description:

Hand Robotic Training

Treatment:

Device: Hand Robotic Training

Hand and Arm Robotic Training

Experimental group

Description:

Hand and Arm Robotic Training

Treatment:

Device: Hand and Arm Robotic Training

Conventional therapy

Active Comparator group

Description:

Conventional therapy

Treatment:

Other: Conventional therapy