StrokeNCT05903235
Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation
A study testing Virtual Reality-based Mirror Therapy (VR+MT), Mixed Reality-based Mirror Therapy (MR+MT) and Traditional Mirror Therapy (MT) in people with Stroke and Cerebrovascular Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
- What is being tested?
- Virtual Reality-based Mirror Therapy (VR+MT), Mixed Reality-based Mirror Therapy (MR+MT) and Traditional Mirror Therapy (MT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2024to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- diagnosed with unilateral stroke
- more than 6 months after stroke onset
Show all 10Show fewer
- 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
- capable of participating in the assessment process and treatment program
Who cannot join
- 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
- Phase Ⅱ: Validation and Comparison of Clinical Treatment Efficacy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taoyuan Chang Gung Memorial Hospital
Taoyuan City, 333
Yu-Wei Hsieh, PhD, +886-3-2118800 ext. 3820, ywhsieh@mail.cgu.edu.tw
About this study
Official title: Technology-based and Activity-based Design of Mirror Therapy Principles: Two Mixed Reality and Virtual Reality Mirrored-hand Systems for Stroke Rehabilitation
The specific study aims will be:
- To design and develop the hardware and software of the VR+MT and MR+MT systems.
- 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.
- 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.
- 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.
Read the detailed description
Phase Ⅰ: Design and Development of the VR+MT and MR+MT Systems \& Feasibility Study
Sixteen patients with stroke will be recruited in this phase Ⅰ study. During the pilot testing, each stroke patient will use each of the VR+MT and MR+MT systems with the assistance of a researcher holding the occupational therapist certification. The order of the feasibility test of the 2 systems will be counterbalanced across the patients. At the end of the feasibility study of each system, the patients will be asked to complete the System Usability Scale, Virtual Reality Sickness Questionnaire, and a self-designed questionnaire to assess the user experience and perspective about these new systems and their view of its suitability for stroke patients.
Phase Ⅱ: Validation and Comparison of Clinical Treatment Efficacy
This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of VR+MT, MR+MT, and traditional MT. An estimated 45 patients with stroke will be recruited to participate in this phase Ⅱ study. Each participant will receive a total of 15 training sessions (40 minutes per session) within 5 weeks. Clinical outcome measures will be conducted at baseline, at immediately after treatment, and at 1 month follow-up after treatment.
- Being tested
- Virtual Reality-based Mirror Therapy (VR+MT), Mixed Reality-based Mirror Therapy (MR+MT), Traditional Mirror Therapy (MT)
- Keywords
- digital rehabilitation, mixed reality, virtual reality, cerebrovascular accident, mirror visual feedback
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based Mirror Therapy (VR+MT)Behavioural
In 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)Behavioural
In 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)Behavioural
In 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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-based Mirror Therapy (VR+MT) | Experimental | In each therapy session, the patients will execute 2 upper-limb functional tasks, starting with easy then more complex tasks. Receives: Behavioral: Virtual Reality-based Mirror Therapy (VR+MT) |
| Mixed Reality-based Mirror Therapy (MR+MT) | Experimental | The patients will execute 2 upper-limb functional tasks in each session. Receives: Behavioral: Mixed Reality-based Mirror Therapy (MR+MT) |
| Traditional Mirror Therapy (MT) | Active comparator | The patients will execute 2 to 3 categories of activities per training session: (1) active range of motion exercises, (2) reaching movement or object manipulation, and (3) upper-limb functional tasks. Receives: Behavioral: Traditional Mirror Therapy (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 5 weeks, 9 weeks
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.
Measured: baseline, 5 weeks, 9 weeks
Secondary outcomes (8)
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.
Measured: baseline, 5 weeks, 9 weeks
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.
Measured: baseline, 5 weeks, 9 weeks
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.
Measured: baseline, 5 weeks, 9 weeks
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.
Measured: baseline, 5 weeks, 9 weeks
Change scores of Revised Nottingham Sensory Assessment
The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to evaluate sensory function of patients following stroke. The scores of the tactile sensation, proprioception, and stereognosis subscales range from 0 to 108, from 0 to 21, and from 0 to 22, respectively; a higher score indicates better somatosensory function.
Measured: baseline, 5 weeks, 9 weeks
Change scores of Chedoke Arm and Hand Activity Inventory
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to evaluate the independence of patients following stroke to perform activities of daily living with an affected upper limb. Each task scores ranged from 1 (total assist) to 7 (complete independence) with a total score range of 13 to 91. A higher score indicates greater recovery of arm and hand function.
Measured: baseline, 5 weeks, 9 weeks
Change scores of the health state of EQ-5D-5L
The questionnaire of EQ-5D-5L comprises 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5-dimension questionnaire represents the health state.
Measured: baseline, 5 weeks, 9 weeks
Change scores of the visual analogue scale of EQ-5D-5L
The visual analogue scale of EQ-5D-5L score will be scored from 0 to 100. A higher score indicates better overall current health.
Measured: baseline, 5 weeks, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start13 Mar 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Wei Hsieh, PhD, Principal investigator, Department of Occupational Therapy, College of Medicine, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903235
- Sponsor's protocol ID
- 202201968A3
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No