NCT02878746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

August 15, 2016

Last Update Submit

March 30, 2021

Conditions

Stroke

Keywords

Mirror therapyProprioceptionRehabilitationStrokeHemiplegia

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer assessment scale

    Change from baseline data at 2 weeks

Secondary Outcomes (8)

  • Thumb finding test

    Before treatment, after 2 weeks, after 2 months

  • Modified Ashworth scale

    Before treatment, after 2 weeks, after 2 months

  • Modified Barthel index

    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

  • +3 more secondary outcomes

Study Arms (2)

Robotic mirror therapy

EXPERIMENTAL

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

Device: Robotic mirror therapy

Conventional mirror therapy

ACTIVE COMPARATOR

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

Device: Conventional mirror therapy

Interventions

Robotic mirror therapyDEVICE

2-dimensional

Robotic mirror therapy
Conventional mirror therapyDEVICE

2- and 3-dimensional

Conventional mirror therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (5)

  • Hamzei F, Lappchen CH, Glauche V, Mader I, Rijntjes M, Weiller C. Functional plasticity induced by mirror training: the mirror as the element connecting both hands to one hemisphere. Neurorehabil Neural Repair. 2012 Jun;26(5):484-96. doi: 10.1177/1545968311427917. Epub 2012 Jan 13.

    PMID: 22247501BACKGROUND

  • Pandian JD, Arora R, Kaur P, Sharma D, Vishwambaran DK, Arima H. Mirror therapy in unilateral neglect after stroke (MUST trial): a randomized controlled trial. Neurology. 2014 Sep 9;83(11):1012-7. doi: 10.1212/WNL.0000000000000773. Epub 2014 Aug 8.

    PMID: 25107877BACKGROUND

  • Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.

    PMID: 19074686BACKGROUND

  • Thieme H, Bayn M, Wurg M, Zange C, Pohl M, Behrens J. Mirror therapy for patients with severe arm paresis after stroke--a randomized controlled trial. Clin Rehabil. 2013 Apr;27(4):314-24. doi: 10.1177/0269215512455651. Epub 2012 Sep 7.

    PMID: 22960240BACKGROUND

  • Bhasin A, Padma Srivastava MV, Kumaran SS, Bhatia R, Mohanty S. Neural interface of mirror therapy in chronic stroke patients: a functional magnetic resonance imaging study. Neurol India. 2012 Nov-Dec;60(6):570-6. doi: 10.4103/0028-3886.105188.

    PMID: 23287316BACKGROUND

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 25, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)