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CompletedNCT02077439Updated Feb 24, 2017

Interactive Intention-Driven Upper-Limb Training Robotic System

An interventional study of Hand Robotic Training and Hand and Arm Robotic Training in Stroke, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

Keywords

  • Stroke
  • Hand
  • Upper Extremity
  • Robotics
03

In context

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Hand Robotic Training

    Hand Robotic Training

    Device: Hand Robotic Training

  • Experimental
    Hand and Arm Robotic Training

    Hand and Arm Robotic Training

    Device: Hand and Arm Robotic Training

  • Active comparator
    Conventional therapy

    Conventional therapy

    Other: Conventional therapy

Interventions

  • DeviceHand Robotic Training

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

  • DeviceHand and Arm Robotic Training

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

  • OtherConventional therapy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months

  2. 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.

    Time frame: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months

Secondary outcomes

  1. 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.

    Time frame: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months

  2. 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.

    Time frame: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months

07

Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02077439
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Raymond KY Tong (Prof., The Hong Kong Polytechnic University) — Principal investigator
First posted
Mar 4, 2014
Start date
Jan 2014
Primary completion
Dec 31, 2015
Completion
Dec 31, 2016
Last update
Feb 24, 2017

Study contacts

Raymond KY Tong, PhD
principal investigator · The Hong Kong Polytechnic University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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