Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms
- Conditions
- Stroke
- Interventions
- Device: Robotic mirror therapyDevice: Conventional mirror therapy
- Registration Number
- NCT02878746
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2
- 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.
- Severe spasticity with modified Ashworth scale of grade 3 or more;
- Mini-mental state examination score less than 12
- Global or sensory aphasia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic mirror therapy Robotic mirror therapy For 30 min per day for two weeks (10 sessions) Conventional mirror therapy Conventional mirror therapy For 30 min per day for two weeks (10 sessions)
- Primary Outcome Measures
Name Time Method Fugl-Meyer assessment scale Change from baseline data at 2 weeks
- Secondary Outcome Measures
Name Time Method Hemispatial neglect test Before treatment, after 2 weeks, after 2 months Fugl-Meyer assessment scale after 2 months Modified Barthel index Before treatment, after 2 weeks, after 2 months Functional brain MRI Before treatment, after 2 weeks Thumb finding test Before treatment, after 2 weeks, after 2 months Modified Ashworth scale Before treatment, after 2 weeks, after 2 months Hand power(lb) assessed by dynamometer Before treatment, after 2 weeks, after 2 months Jebsen hand function test Before treatment, after 2 weeks, after 2 months
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of