Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Stroke Clinical Trial

Official title:

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878746
• Other study ID #: SNUH-1209-051-425
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Robotic mirror therapy
2-dimensional
• Conventional mirror therapy
2- and 3-dimensional

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

Dohle C, Püllen J, Nakaten A, Küst 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. — View Citation

Hamzei F, Läppchen 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer assessment scale		Change from baseline data at 2 weeks
Secondary	Thumb finding test		Before treatment, after 2 weeks, after 2 months
Secondary	Modified Ashworth scale		Before treatment, after 2 weeks, after 2 months
Secondary	Modified Barthel index		Before treatment, after 2 weeks, after 2 months
Secondary	Hand power(lb) assessed by dynamometer		Before treatment, after 2 weeks, after 2 months
Secondary	Jebsen hand function test		Before treatment, after 2 weeks, after 2 months
Secondary	Hemispatial neglect test		Before treatment, after 2 weeks, after 2 months
Secondary	Functional brain MRI		Before treatment, after 2 weeks
Secondary	Fugl-Meyer assessment scale		after 2 months