StrokeNCT06056219
Rhythmic-Based Training with Immersive Mirror Visual Feedback for Neuro-Rehabilitation
A study testing Mirror therapy, Virtual reality-based mirror therapy with rhythmic skill training and Task-oriented training in people with Stroke and Rehabilitation, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback 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 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Rehabilitation, Virtual Reality
- What is being tested?
- Mirror therapy, Virtual reality-based mirror therapy with rhythmic skill training and Task-oriented training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Oct 2023to 24 Oct 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 18 years and older
- 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
- Severe vision and hearing impairment;
- Major cognitive-perceptual deficit;
- Other brain disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Rhythmic-Based Training with Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity
In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback 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 rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.
- Conditions
- Stroke, Rehabilitation, Virtual Reality, Mirror Movement Therapy
- Being tested
- Mirror therapy, Virtual reality-based mirror therapy with rhythmic skill training, 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.
Mirror therapyDevice
30 minutes' mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise of less-affected upper extremity using a mirror box
Virtual reality-based mirror therapy with rhythmic skill trainingDevice
30 minutes' virtual reality-based mirror therapy with rhythmic skill training included musical exercises involving virtual drums playing with less-affected upper extremity, and synchronized virtual drums playing and singing activity
Task-oriented trainingOther
20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy using a mirror box | Active comparator | 30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training Receives: Device: Mirror therapy; Other: Task-oriented training |
| Virtual reality-based mirror therapy with rhythmic skill training | Experimental | 30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training Receives: Device: Virtual reality-based mirror therapy with rhythmic skill training; 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 motor performance score ranges from 0 to 66 for the upper extremity.
Measured: baseline, 9 weeks and 21 weeks
Secondary outcomes (4)
Change in the result of Box and block test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. The minimum and maximum value is 0 and 150 respectively.
Measured: baseline, 9 weeks and 21 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 (ROM); 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, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilament test examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome
Measured: baseline, 9 weeks and 21 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 activities of daily living. Score range from 0-5. Higher values represent a better outcome
Measured: baseline, 9 weeks and 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start3 Oct 2023
- Primary completion15 Oct 2024
- Study completion24 Oct 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT06056219
- Sponsor's protocol ID
- B-ER-112-174
- Status last verified
- Nov 2024
- First submitted
- 17 Sep 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic-Based Training with Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity
- ClinicalTrials.gov ID
- NCT06056219
- Acronym / sponsor ID
- B-ER-112-174
- Conditions
- Stroke, Rehabilitation, Virtual Reality, Mirror Movement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 28 Sep 2023 (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 rhythmic-based training with immersive mirror visual feedback 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 rhythmic-based training with immersive mirror visual feedback, or mirror 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
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy using a mirror box | Active comparator | Device: Mirror therapy, Other: Task-oriented training30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training |
| Virtual reality-based mirror therapy with rhythmic skill training | Experimental | Device: Virtual reality-based mirror therapy with rhythmic skill training, Other: Task-oriented training30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training |
Who may qualify
- Ages
- 18 years and older
- 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)
- Severe vision and hearing impairment;
- 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 |
|---|---|---|
| Mirror therapy30 minutes' mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise of less-affected upper extremity using a mirror box | Device | Mirror therapy using a mirror box |
| Virtual reality-based mirror therapy with rhythmic skill training30 minutes' virtual reality-based mirror therapy with rhythmic skill training included musical exercises involving virtual drums playing with less-affected upper extremity, and synchronized virtual drums playing and singing activity | Device | Virtual reality-based mirror therapy with rhythmic skill training |
| Task-oriented training20 minutes' motor training targeted to goals that are relevant to the functional needs of the patient | Other | Mirror therapy using a mirror box, Virtual reality-based mirror therapy with rhythmic skill training |
Primary outcome
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Time frame: baseline, 9 weeks and 21 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 motor performance score ranges from 0 to 66 for the upper extremity.
4 secondary outcomes
Change in the result of Box and block test
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Modified Ashworth scale (MAS)
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Semmes-Weinstein monofilament (SWM) test
Time frame: baseline, 9 weeks and 21 weeks
Change in the result of Motor Activity Log
Time frame: baseline, 9 weeks and 21 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 16 Dec 2024.
- Individual participant dataSharing planned: No
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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 Mirror therapy, Virtual reality-based mirror therapy with rhythmic skill training and Task-oriented training in people with Stroke and Rehabilitation, 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 16 Dec 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, 9 weeks and 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.