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Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02878746
Enrollment
2
Registered
2016-08-25
Start date
2016-01-31
Completion date
2016-05-31
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Mirror therapy, Proprioception, Rehabilitation, Stroke, Hemiplegia

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.

Interventions

DEVICERobotic mirror therapy

2-dimensional

2- and 3-dimensional

Sponsors

Seoul National University
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer assessment scaleChange from baseline data at 2 weeks

Secondary

MeasureTime frame
Modified Ashworth scaleBefore treatment, after 2 weeks, after 2 months
Modified Barthel indexBefore treatment, after 2 weeks, after 2 months
Hand power(lb) assessed by dynamometerBefore treatment, after 2 weeks, after 2 months
Thumb finding testBefore treatment, after 2 weeks, after 2 months
Hemispatial neglect testBefore treatment, after 2 weeks, after 2 months
Functional brain MRIBefore treatment, after 2 weeks
Fugl-Meyer assessment scaleafter 2 months
Jebsen hand function testBefore treatment, after 2 weeks, after 2 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026