ClinicalTrials.Veeva

Menu

Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Stroke

Treatments

Device: Robotic mirror therapy
Device: Conventional mirror therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02878746
SNUH-1209-051-425

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

19+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

2 participants in 2 patient groups

Robotic mirror therapy
Experimental group
Description:
For 30 min per day for two weeks (10 sessions)
Treatment:
Device: Robotic mirror therapy
Conventional mirror therapy
Active Comparator group
Description:
For 30 min per day for two weeks (10 sessions)
Treatment:
Device: Conventional mirror therapy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems