Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Recruiting

Phase N/A Results N/A

Trial Description

The investigators developed a real-time 2-axis mirror robot system as a simple add-on module for conventional mirror therapy using a closed feedback mechanism, which allows for real-time movement of the hemiplegic arm. The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training.

Detailed Description

The investigators conduct a case study for stroke patients with a two-dimensional mirror robot for 30 min per day for two weeks (10 sessions). For the conventional mirror therapy group, the investigators prepared the tasks for fine motor training. These tasks included more complicated tasks so that the participants would be interested in the tasks without the robot system.
Before and after 10 sessions of the therapy, the investigators conduct functional evaluations: the Fugl-Meyer assessment scale of the upper extremity (FMA-UE), the modified Ashworth scale, the modified Barthel index of upper extremity (MBI-UE: personal hygiene, bathing, feeding, and dressing), and the Jebsen hand function test, hand power measurement, and hemispatial neglect test (line bisection test and Albert's test) with the same occupational therapist. The motor evoked potential was measured for the patients without the history of brain surgery or seizure.
The investigators selected a thumb finding test (TFT) among various tools for assessing proprioception, because TFT is widely used and reliable. The TFT can be assessed, after confirming normal proprioception in the unaffected arm, by the patient touching the nose with their eyes closed while the examiner lifts the affected arm to eye level. The patient is then asked to grasp the thumb of the affected hand with the unaffected hand, and this is repeated. The examiner then places a hand over the patient's eyes and raises the patient's affected hand to well above the patient's head. The patient is then asked to grasp the thumb as before.

Conditions

Interventions

  • Robotic mirror therapy Device
    Intervention Desc: 2-dimensional
    ARM 1: Kind: Experimental
    Label: Robotic mirror therapy
    Description: For 30 min per day for two weeks (10 sessions)
  • Conventional mirror therapy Device
    Intervention Desc: 2- and 3-dimensional
    ARM 1: Kind: Experimental
    Label: Conventional mirror therapy
    Description: For 30 min per day for two weeks (10 sessions)

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 scale Change from baseline data at 2 weeks No
Secondary Thumb finding test Before treatment, after 2 weeks, after 2 months No
Secondary Modified Ashworth scale Before treatment, after 2 weeks, after 2 months No
Secondary Modified Barthel index Before treatment, after 2 weeks, after 2 months No
Secondary Hand power(lb) assessed by dynamometer Before treatment, after 2 weeks, after 2 months No
Secondary Jebsen hand function test Before treatment, after 2 weeks, after 2 months No
Secondary Hemispatial neglect test Before treatment, after 2 weeks, after 2 months No
Secondary Functional brain MRI Before treatment, after 2 weeks No

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