Rehabilitation, Mirror Neurons, StrokeNCT03329417
Neurorehabilitation Using a Virtual Reality-based Mirror Therapy
A study testing task-oriented training in people with Rehabilitation, Mirror Neurons, Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In the proposed study, the investigators assumed that mirror therapy combined with virtual reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Mirror Neurons, Stroke
- What is being tested?
- task-oriented training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Nov 2017to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Vision loss;
- Major cognitive-perceptual deficit;
- Other brain disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Virtual Reality-Based Mirror NeuroRehabilitation System (VR-based MNRS) on Functional Performance of Upper Extremity for Unilateral Stroke Patients
In the proposed study, the investigators assumed that mirror therapy combined with virtual reality technology will provide a better treatment effects than traditional mirror therapy 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 virtual reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.
- Conditions
- Rehabilitation, Mirror Neurons, Stroke
- Being tested
- task-oriented training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task-oriented trainingOther
Motor training targeted to goals that are relevant to the functional needs of the patient
| Study group | Role | What they receive |
|---|---|---|
| Traditional occupational therapy | Active comparator | The program includes 30 minutes of traditional occupational therapy (sensorimotor facilitation techniques, such as: Rood, Bobath and propriocetive-neuromuscular-facilitation), followed by 20 minutes of motor task specific training in each treatment session. Receives: Other: task-oriented training |
| Mirror therapy using a mirror box | Active comparator | The program includes 30 minutes of mirror therapy, followed by 20 minutes of regular motor task specific training in each treatment session. Receives: Other: task-oriented training |
| Virtual reality based mirror therapy | Experimental | The program includes 30 minutes treatment session of virtual reality mirror therapy, followed by 20 minutes of motor task specific training in each treatment session. Receives: Other: task-oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks and 18 weeks
Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.
Measured: baseline, 6 weeks and 18 weeks
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.
Measured: baseline, 6 weeks and 18 weeks
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.
Measured: baseline, 6 weeks and 18 weeks
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 0-180. Higher values represent a better outcome.
Measured: baseline, 6 weeks and 18 weeks
Secondary outcomes (2)
Change in Power Spectrum of the Electroencephalography (EEG)
Power spectrum is computed for the alpha (8-13 Hz) and beta (14-24 Hz) frequency bands. Higher values represent a better outcome.
Measured: baseline and 6 weeks
Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation
Cortical silent period of to evaluate intercortical facilitation of brain. Lower values represent a better outcome.
Measured: baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start13 Nov 2017
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rehabilitation, Mirror Neurons, 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329417
- Sponsor's protocol ID
- A-ER-105-213
- Status last verified
- Mar 2023
- First submitted
- 30 Oct 2017
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu HY, Kuo LC, Lin YC, Su FC, Yang TH, Lin CW. Effects of a Virtual Reality-Based Mirror Therapy Program on Improving Sensorimotor Function of Hands in Chronic Stroke Patients: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Jun;36(6):335-345. doi: 10.1177/15459683221081430. Epub 2022 Mar 28.
PubMed 35341360
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Virtual Reality-Based Mirror NeuroRehabilitation System (VR-based MNRS) on Functional Performance of Upper Extremity for Unilateral Stroke Patients
- ClinicalTrials.gov ID
- NCT03329417
- Acronym / sponsor ID
- A-ER-105-213
- Conditions
- Rehabilitation, Mirror Neurons, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the proposed study, the investigators assumed that mirror therapy combined with virtual reality technology will provide a better treatment effects than traditional mirror therapy 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 virtual reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional occupational therapy | Active comparator | Other: task-oriented trainingThe program includes 30 minutes of traditional occupational therapy (sensorimotor facilitation techniques, such as: Rood, Bobath and propriocetive-neuromuscular-facilitation), followed by 20 minutes of motor task specific training in each treatment session. |
| Mirror therapy using a mirror box | Active comparator | Other: task-oriented trainingThe program includes 30 minutes of mirror therapy, followed by 20 minutes of regular motor task specific training in each treatment session. |
| Virtual reality based mirror therapy | Experimental | Other: task-oriented trainingThe program includes 30 minutes treatment session of virtual reality mirror therapy, followed by 20 minutes of motor task specific training in each treatment session. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Vision loss;
- Major cognitive-perceptual deficit;
- Other brain disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| task-oriented trainingMotor training targeted to goals that are relevant to the functional needs of the patient | Other | Mirror therapy using a mirror box, Traditional occupational therapy, Virtual reality based mirror therapy |
Primary outcome
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Time frame: baseline, 6 weeks and 18 weeks
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.
Change in the result of Modified Ashworth scale (MAS)
Time frame: baseline, 6 weeks and 18 weeks
Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.
Change in the result of Box and blocks test
Time frame: baseline, 6 weeks and 18 weeks
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time frame: baseline, 6 weeks and 18 weeks
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Change in the result of Motor Activity Log
Time frame: baseline, 6 weeks and 18 weeks
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-180. Higher values represent a better outcome.
2 secondary outcomes
Change in Power Spectrum of the Electroencephalography (EEG)
Time frame: baseline and 6 weeks
Changes in Cortical Excitability Assessed by Transcranial Magnetic Stimulation
Time frame: baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 35341360Hsu HY, Kuo LC, Lin YC, Su FC, Yang TH, Lin CW. Effects of a Virtual Reality-Based Mirror Therapy Program on Improving Sensorimotor Function of Hands in Chronic Stroke Patients: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Jun;36(6):335-345. doi: 10.1177/15459683221081430. Epub 2022 Mar 28.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing task-oriented training in people with Rehabilitation, Mirror Neurons, Stroke, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test (time frame: baseline, 6 weeks and 18 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.