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Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Robotic mirror therapy

Conventional mirror therapy

About this trial

This is an interventional treatment trial for Stroke focused on measuring Mirror therapy, Proprioception, Rehabilitation, Stroke, Hemiplegia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic mirror therapy

Conventional mirror therapy

Arm Description

For 30 min per day for two weeks (10 sessions)

Outcomes

Primary Outcome Measures

Fugl-Meyer assessment scale

Secondary Outcome Measures

Thumb finding test

Modified Ashworth scale

Modified Barthel index

Hand power(lb) assessed by dynamometer

Jebsen hand function test

Hemispatial neglect test

Functional brain MRI

Fugl-Meyer assessment scale

Full Information

NCT ID

NCT02878746

First Posted

August 15, 2016

Last Updated

March 30, 2021

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University

1. Study Identification

Unique Protocol Identification Number

NCT02878746

Brief Title

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Official Title

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Seoul National University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Mirror therapy, Proprioception, Rehabilitation, Stroke, Hemiplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Robotic mirror therapy

Arm Type

Experimental

Arm Description

For 30 min per day for two weeks (10 sessions)

Arm Title

Conventional mirror therapy

Arm Type

Active Comparator

Arm Description

For 30 min per day for two weeks (10 sessions)

Intervention Type

Device

Intervention Name(s)

Robotic mirror therapy

Intervention Description

2-dimensional

Intervention Type

Device

Intervention Name(s)

Conventional mirror therapy

Intervention Description

2- and 3-dimensional

Primary Outcome Measure Information:

Title

Fugl-Meyer assessment scale

Time Frame

Change from baseline data at 2 weeks

Secondary Outcome Measure Information:

Title

Thumb finding test

Time Frame