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Completed

NCT Number: NCT02077439

Interactive Intention-Driven Upper-Limb Training Robotic System

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand Robotic Training

Device

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

Hand and Arm Robotic Training

Device

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

Conventional Therapy

Other

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

Primary outcomes

  1. Fugl-Meyer Assessment

    Time frame: 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.

  2. Action Research Arm Test

    Time frame: 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.

Secondary outcomes

  1. Wolf Motor Function Test

    Time frame: 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.

  2. modified Ashworth Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 4, 2014
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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