Virtual Reality Mirror Therapy With Focused Object-Directed Attention System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Cheng-Kung University Hospital
About this trial
In this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke.
The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in 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;
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 interventionVirtual Reality Mirror Therapy combined with Motor training targeted to goals that are relevant to the functional needs of the patient
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Virtual Reality Mirror Therapy GroupActive comparator 1 intervention
Group B: Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA)Experimental treatment 1 intervention
Group C: VRMTFOA with auditory feedbackActive comparator 1 intervention
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov