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Completed

NCT Number: NCT02878746

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years old
  • Supratentorial stroke diagnosed between 4 months and 6 years ago
  • Upper-limb hemiplegia with Medical Research Council grade 2 or less.

Exclusion criteria

  • Severe spasticity with modified Ashworth scale of grade 3 or more;
  • Mini-mental state examination score less than 12
  • Global or sensory aphasia.

Treatment and study plan

Robotic mirror therapy

Device

2-dimensional

Conventional mirror therapy

Device

2- and 3-dimensional

Primary outcomes

  1. Fugl-Meyer assessment scale

    Time frame: Change from baseline data at 2 weeks

Secondary outcomes

  1. Thumb finding test

    Time frame: Before treatment, after 2 weeks, after 2 months

  2. Modified Ashworth scale

    Time frame: Before treatment, after 2 weeks, after 2 months

  3. Modified Barthel index

    Time frame: Before treatment, after 2 weeks, after 2 months

  4. Hand power(lb) assessed by dynamometer

    Time frame: Before treatment, after 2 weeks, after 2 months

  5. Jebsen hand function test

    Time frame: Before treatment, after 2 weeks, after 2 months

  6. Hemispatial neglect test

    Time frame: Before treatment, after 2 weeks, after 2 months

  7. Functional brain MRI

    Time frame: Before treatment, after 2 weeks

  8. Fugl-Meyer assessment scale

    Time frame: after 2 months

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2016
Registry last updated
Apr 2, 2021

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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