Effects of Virtual Reality Multisensory Cooperative Task-Oriented Mirror Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Cheng-Kung University Hospital
About this trial
In the proposed study, the investigators assumed that Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Therapy (VRMCTOMT) will provide a better treatment effects than traditional virtual reality mirror therapy (VRMT) for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either VRMCTOMT, or VRMT on the upper extremity function and brain activity of the stroke patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of stroke with unilateral side involved;
A score of Mini-mental state examination greater than 24 for proving higher mental function
Time of onset > 6 months before treatment begins; and
Premorbid right-handedness.
Disqualifiers
Severe vision impairment;
Major cognitive-perceptual deficit;
Other brain disease.
Trial design
Design model
Parallel
Treatments tested in this trial
task-oriented training
Other interventionMotor training targeted to goals that are relevant to the functional needs of the patient
Virtual Reality Mirror Therapy
Other interventionVirtual Reality Mirror Therapy using goggle
Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy
Other interventionVirtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy using goggle
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality Mirror Therapy GroupActive comparator 2 interventions
Group B: Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
Time frame
baseline, 9 weeks and 21 weeksSecondary outcomes
1
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by assess muscle tone by evaluating resistance to passive stretch, reflecting the level of spasticity, with scores ranging from 0 (no increase in tone) to 4 (rigidity in flexion or extension).
Time frame
baseline, 9 weeks and 21 weeksOther outcomes
1
Change in the result of Box and blocks test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Time frame
baseline, 9 weeks and 21 weeks2
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Time frame
baseline, 9 weeks and 21 weeks3
Change in the result of Motor Activity Log
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.
Time frame
baseline, 9 weeks and 21 weeks4
functional Magnetic Resonance Imaging
a non-invasive neuroimaging technique that measures brain activity by detecting changes in blood oxygenation (BOLD signal).
Time frame
baseline, 9 weeksSponsors and contacts
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Source ClinicalTrials.gov