Interactive Intention-Driven Upper-Limb Training Robotic System

NCT ID: NCT02077439

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hand Robotic Training

Hand Robotic Training

Group Type EXPERIMENTAL

Hand Robotic Training

Intervention Type DEVICE

Training for 20 sessions for one hour, 3-5 times per week.

Hand and Arm Robotic Training

Hand and Arm Robotic Training

Group Type EXPERIMENTAL

Hand and Arm Robotic Training

Intervention Type DEVICE

Training for 20 sessions for one hour, 3-5 times per week.

Conventional therapy

Conventional therapy

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type OTHER

Training for 20 sessions for one hour, 3-5 times per week.

Interventions

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Hand Robotic Training

Training for 20 sessions for one hour, 3-5 times per week.

Intervention Type DEVICE

Hand and Arm Robotic Training

Training for 20 sessions for one hour, 3-5 times per week.

Intervention Type DEVICE

Conventional therapy

Training for 20 sessions for one hour, 3-5 times per week.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond KY Tong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Related Links

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http://www.polyu.edu.hk

The Hong Kong Polytechnic University

Other Identifiers

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ITT/004/12GP

Identifier Type: -

Identifier Source: org_study_id

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