Clinical trial NCT02878746: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Mirror therapy
Proprioception
Rehabilitation
Stroke
Hemiplegia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2016-08-25
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer assessment scale
timeFrame: Change from baseline data at 2 weeks
Secondary outcomes:
measure: Thumb finding test
timeFrame: Before treatment, after 2 weeks, after 2 months
measure: Modified Ashworth scale
timeFrame: Before treatment, after 2 weeks, after 2 months
measure: Modified Barthel index
timeFrame: Before treatment, after 2 weeks, after 2 months
measure: Hand power(lb) assessed by dynamometer
timeFrame: Before treatment, after 2 weeks, after 2 months
measure: Jebsen hand function test
timeFrame: Before treatment, after 2 weeks, after 2 months
measure: Hemispatial neglect test
timeFrame: Before treatment, after 2 weeks, after 2 months
measure: Functional brain MRI
timeFrame: Before treatment, after 2 weeks
measure: Fugl-Meyer assessment scale
timeFrame: after 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.