Interactive Intention-Driven Upper-Limb Training Robotic System

Recruiting

Phase N/A Results N/A

Trial Description

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

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

Interventions

  • Conventional therapy Other
    Intervention Desc: Training for 20 sessions for one hour, 3-5 times per week.
    ARM 1: Kind: Experimental
    Label: Conventional therapy
    Description: Conventional therapy
  • Hand Robotic Training Device
    Intervention Desc: Training for 20 sessions for one hour, 3-5 times per week.
    ARM 1: Kind: Experimental
    Label: Hand Robotic Training
    Description: Hand Robotic Training
  • Hand and Arm Robotic Training Device
    Intervention Desc: Training for 20 sessions for one hour, 3-5 times per week.
    ARM 1: Kind: Experimental
    Label: Hand and Arm Robotic Training
    Description: Hand and Arm Robotic Training

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months No
Primary Action Research Arm Test Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months No
Secondary Wolf Motor Function Test Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months No
Secondary modified Ashworth Scale Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months No

Sponsors