Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02878746
Collaborator
Seoul National University (Other)
2
1
2
4
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Robotic mirror therapy
  • Device: Conventional mirror therapy
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Robotic mirror therapy

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

Device: Robotic mirror therapy
2-dimensional

Active Comparator: Conventional mirror therapy

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

Device: Conventional mirror therapy
2- and 3-dimensional

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer assessment scale [Change from baseline data at 2 weeks]

Secondary Outcome Measures

  1. Thumb finding test [Before treatment, after 2 weeks, after 2 months]

  2. Modified Ashworth scale [Before treatment, after 2 weeks, after 2 months]

  3. Modified Barthel index [Before treatment, after 2 weeks, after 2 months]

  4. Hand power(lb) assessed by dynamometer [Before treatment, after 2 weeks, after 2 months]

  5. Jebsen hand function test [Before treatment, after 2 weeks, after 2 months]

  6. Hemispatial neglect test [Before treatment, after 2 weeks, after 2 months]

  7. Functional brain MRI [Before treatment, after 2 weeks]

  8. Fugl-Meyer assessment scale [after 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Seoul National University Hospital
  • Seoul National University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sun Gun Chung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02878746
Other Study ID Numbers:
  • SNUH-1209-051-425
First Posted:
Aug 25, 2016
Last Update Posted:
Apr 2, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Sun Gun Chung, Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2021