Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChang Gung Memorial Hospital
About this trial
The specific study aims will be:
1. To design and develop the hardware and software of the VR+MT and MR+MT systems. 2. To test the feasibility of the VR+MT and MR+MT systems from the patients and to collect the feedback of users with respect to their experiences. 3. To examine the treatment effects of VR+MT and MR+MT compared to the traditional MT (i.e., control group) in patients with stroke by conducting a randomized controlled trial. 4. To identify who will be the possible good responders to VR+MT and MR+MT based on their baseline motor functions and mental imagery abilities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with unilateral stroke
age of 20 to 80 years
a baseline Fugl-Meyer Assessment of the Upper Extremity score of 20 to 60
able to follow the study instructions and provide the feedback of user experiences verbally
Disqualifiers
diagnosed with global or receptive aphasia
the presence of severe neglect
the existence of major medical problems or comorbidities that could interfere with upper-limb usage and pain, or disrupt visual or auditory perception
diagnosed with unilateral stroke
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality-based Mirror Therapy (VR+MT)
BehavioralIn this VR+MT group, the patients will be instructed to perform the unilateral movements of the non-affected upper limb simultaneously while observing the animated hand as mirroring reflection of the affected hand within the immersive environment, which presented on the goggle via the VR+MT system.
Mixed Reality-based Mirror Therapy (MR+MT)
BehavioralIn the MR+MT group, the patients will be instructed to perform the unilateral movements of the non-affected upper limb concurrently meanwhile watching the real-time mirroring image reflection of the non-affected upper limb's movements of the patients captured, transformed, and superimposed on the affected upper limb, which projected to the screen from the front side via the MR+MT system.
Traditional Mirror Therapy (MT)
BehavioralIn the traditional MT group, patients will be instructed to perform the unilateral movements of the non-affected upper limb at the same time while watching the mirror of a mirror box placed in front of the patient's midsagittal plane, in which the illusory reflection of the non-affected upper limb appears as if it were the another affected upper limb.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Virtual Reality-based Mirror Therapy (VR+MT)Experimental treatment 1 intervention
Group B: Mixed Reality-based Mirror Therapy (MR+MT)Experimental treatment 1 intervention
Group C: Traditional Mirror Therapy (MT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change scores of Fugl-Meyer Assessment of the Upper Extremity
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a measure with sound psychometric properties to evaluate upper-limb hemiparesis of patients following stroke. The total, proximal and distal scores of the FMA-UE range from 0 to 66, from 0 to 42, and from 0 to 24, respectively; a higher score indicates better upper-limb motor function.
Time frame
baseline, 5 weeks, 9 weeks2
Change scores of Nottingham Extended Activities of Daily Living scale
The Nottingham Extended Activities of Daily Living scale is an ease-of-use measure with sound reliability and validity to assess independence of more complex daily function. Each item scores ranged from 0 (no/unable) to 3 (on my own/able) with a total score range of 0 to 66. A higher score indicates greater independence of instrumental activities of daily living.
Time frame
baseline, 5 weeks, 9 weeksSecondary outcomes
1
Change scores of grip strengths
The Jamar® Plus+ Digital Hand Dynamometer has been designed similarly to the reliable and validated Jamar Hydraulic Hand Dynamometer to measure the grip strength. The grip strengths of both hands were alternatively measured in kilograms (kg) by adopting the average of three measurements.
Time frame
baseline, 5 weeks, 9 weeks2
Change scores of lateral pinch strengths
The Jamar® Plus+ Digital Pinch Gauge has been developed and widely used with the advantages of an easy-to-read digital readout and being capable of storing data. The lateral pinch strengths of both hands will be alternatively measured in kilograms (kg) by adopting the average of three measurements.
Time frame
baseline, 5 weeks, 9 weeks3
Change scores of palmar pinch strengths
The Jamar® Plus+ Digital Pinch Gauge has been developed and widely used with the advantages of an easy-to-read digital readout and being capable of storing data. The palmar pinch strengths of both hands will be alternatively measured in kilograms (kg) by adopting the average of three measurements.
Time frame
baseline, 5 weeks, 9 weeks4
Change scores of Box and Block Test
The Box and Block Test (BBT) is a tool with sound reliability and validity to evaluate hand dexterity. The number of cubes moved represents the BBT score, with a higher score indicating better gross dexterity.
Time frame
baseline, 5 weeks, 9 weeksSponsors and contacts
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Source ClinicalTrials.gov