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StrokeNCT07426354

Multimodal Sensory Feedback and Mirror Therapy for Stroke Rehabilitation

A study testing MAF-MT: Multimodal Augmeneted Mirror Therapy, Traditional Mirror Therapy and MVF-MT: Digital Mirror Visual Feedback Mirror Therapy in people with Stroke and Hemiparesis After Stroke, run by Asia University at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to investigate the clinical and neurophysiological effects of a novel multimodal sensory feedback mirror therapy in stroke survivors with upper extremity hemiparesis , aged between 20 and 85 years. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Stroke, Hemiparesis After Stroke
What is being tested?
MAF-MT: Multimodal Augmeneted Mirror Therapy, Traditional Mirror Therapy and MVF-MT: Digital Mirror Visual Feedback Mirror Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteTaiwan
Study dates
1 Aug 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 3 months post-onset of a unilateral stroke
  • Age between 20 and 85 years
  • An initial Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score between 18 and 56
  • Ability to follow study instructions, as determined by a Montreal Cognitive Assessment (MoCA) score ≥ 18
  • No concurrent participation in other neurorehabilitation studies or drug clinical trials

Who cannot join

  • Severe neglect, as measured by the line bisection test
  • Uncontrolled major medical conditions, such as uncontrolled hypertension or heart failure, or concomitant neurological conditions, for example, dementia, Parkinson's disease, brain tumors, or other brain conditions
  • Severe pain, swelling, spasticity or contractures in affected arms that prevent movement practice and assessments.

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
  • Taipei Tzu Chi Hospital

    New Taipei City

Other trials in Taiwan

About this study

Official title: Neural Mechanisms and Efficacy of Multimodal Sensory Feedback Augmentation on Mirror Therapy for Stroke Rehabilitation

The goal of this clinical trial is to investigate the clinical and neurophysiological effects of a novel multimodal sensory feedback mirror therapy in stroke survivors with upper extremity hemiparesis , aged between 20 and 85 years.

The main questions it aims to answer are:

Read more
  1. Does Multimodal Augmented Mirror Therapy (MAF-MT) lead to significantly greater improvements in functional recovery compared to unimodal digital mirror visual feedback mirror therapy (MVF-MT) or traditional mirror therapy (TMT) ?
  2. What are the underlying neurophysiological changes in brain activation (mu rhythm desynchronization) and intermuscular coordination patterns associated with this hybridized feedback approach?

Researchers will compare the MAF-MT group (receiving digital mirror visual feedback with multimodal sensory feedback) to the MVF-MT group (digital mirror feedback only) and the TMT group (traditional mirror therapy using the standard mirror box) to see if the integration of multimodal feedback leads to superior functional and brain acitivity outcomes.

Participants will undergo eligibility screening including assessments of motor impairment and cognitive status. They will participate in 20 sessions of intervention, consisting of approximately 75 minutes of assigned therapies. They will receive specific sensory intervention depending on group assignment and complete evaluation (described in Outcome Measures) before the intervention, immediately after, and at a one-month follow-up

Being tested
MAF-MT: Multimodal Augmeneted Mirror Therapy, Traditional Mirror Therapy, MVF-MT: Digital Mirror Visual Feedback Mirror Therapy
Keywords
neurorehabilitation, multimodal sensory feedback
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAF-MT: Multimodal Augmeneted Mirror TherapyBehavioural

    MAF-MT combines somatosensory and auditory feedback with digital mirror visual feedback, providing an overall augmented sensory feedback with the goal to improve sense of embodiment (SoE) during mirror therapy.

  • Traditional Mirror TherapyBehavioural

    TMT uses traditional mirror boxes to provide the mirror visual feedback of the less affected hand during mirror therapy

  • MVF-MT: Digital Mirror Visual Feedback Mirror TherapyBehavioural

    MVF-MT provides real-time digital image of the less affected hand as the mirror visual feedback during mirror therapy

Study groups in NCT07426354
Study groupRoleWhat they receive
MAF-MT: Multimodal Augmented Mirror TherapyExperimentalNot described
Receives: Behavioral: MAF-MT: Multimodal Augmeneted Mirror Therapy
MVF-MT: Digital Mirror Visual Feedback Mirror TherapyActive comparatorNot described
Receives: Behavioral: MVF-MT: Digital Mirror Visual Feedback Mirror Therapy
TMT: Traditional Mirror TherapyPlacebo comparatorNot described
Receives: Behavioral: Traditional Mirror Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment of Upper Extremity (FMA-UE)

    The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor impairment through 33 items measuring the movement and reflexes of the shoulder, elbow, forearm, wrist, and hand, as well as coordination and speed. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), resulting in a maximum total score of 66, where higher scores indicate better motor recovery and lower impairment. This scale is a widely recognized, reliable, and valid tool for assessing motor performance in post-stroke populations.

    Measured: Baseline, 4 weeks, and 8 weeks

Secondary outcomes (13)
  1. Wolf Motor Function Test (WMFT)

    The Wolf Motor Function Test (WMFT) assesses upper extremity motor function through 17 items, consisting of 15 function-based tasks and 2 strength-based tasks. The assessment generates two primary outcomes: performance time and functional ability. Performance time is measured as the average time required to complete the tasks, capped at a maximum of 120 seconds per task, where shorter times indicate better efficiency. Functional ability is rated on a 6-point ordinal scale ranging from 0 ("does not attempt with the involved arm") to 5 ("arm does participate; movement appears to be normal"), where higher scores indicate better movement quality. The WMFT is a widely validated instrument with established psychometric properties for evaluating upper limb motor recovery in stroke patients.

    Measured: Baseline, 4 weeks and 8 weeks

  2. Modified Ashworth Scale (MAS)

    The Modified Ashworth Scale (MAS) will be used to assess the severity of muscle spasticity in the affected upper extremity by measuring resistance to passive movement. The MAS utilizes a 6-point ordinal scale with grades of 0, 1, 1+, 2, 3, and 4. A score of 0 indicates no increase in muscle tone, while a score of 4 indicates that the affected part is rigid in flexion or extension. The specific grade of 1+ represents a slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. Higher scores indicate greater severity of spasticity and increased resistance to passive stretch. The MAS is a widely accepted standard for evaluating spasticity in the stroke population.

    Measured: Baseline, 4 weeks and 8 weeks

  3. Medical Research Council scale (MRC)

    The Medical Research Council (MRC) scale will be used to assess muscle strength in the affected upper extremity. This assessment utilizes a 6-point ordinal scale ranging from 0 (no visible contraction) to 5 (normal strength against full resistance). Specifically, a grade of 3 indicates active movement against gravity, while a grade of 4 indicates active movement against gravity and some resistance. Scores are assigned to specific muscle groups (e.g., shoulder abductors, elbow flexors, and wrist extensors), and the total score is calculated by summing these individual values. Higher scores indicate greater muscle strength and better motor recovery.

    Measured: Baseline, 4 weeks and 8 weeks

  4. Nottingham Extended Activities of Daily Living Scale (NEADL)

    The Nottingham Extended Activities of Daily Living Scale (NEADL) assesses the participant's independence in instrumental activities of daily living across four domains: Mobility, Kitchen, Domestic, and Leisure. This 22-item questionnaire evaluates how often the participant has performed specific activities in the recent past. Items are scored on a 4-point scale ranging from 0 (unable to do) to 3 (able to do on one's own), yielding a total score that ranges from 0 to 66. Higher scores indicate greater independence and participation in extended daily living activities. The NEADL is a widely validated measure for assessing functional recovery and community integration in stroke survivors.

    Measured: Baseline, 4 weeks and 8 weeks

  5. The Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL)

    The Lawton-Brody Instrumental Activities of Daily Living Scale (IADL) assesses the participant's ability to perform eight complex activities required for independent living: using the telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. Each item is generally scored as 0 (dependent) or 1 (independent), yielding a total score ranging from 0 to 8. Higher scores indicate greater functional independence, while lower scores suggest a need for assistance in performing daily tasks. This scale is widely used to monitor functional status and identify decline in older adults and stroke survivors.

    Measured: Baseline, 4 weeks and 8 weeks

  6. EQ-5D-5L

    The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire will be used to assess the participant's health-related quality of life. This instrument comprises a descriptive system covering five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated on a 5-point ordinal scale ranging from 1 (no problems) to 5 (extreme problems/unable to perform). These responses are converted into a single utility index score based on country-specific value sets, where a score of 1 represents perfect health and 0 represents death (with negative values indicating health states considered worse than death). Additionally, the EQ-5D-5L includes a Visual Analogue Scale (EQ-VAS), where participants rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores on both the utility index and the VAS indicate better health-related quality of life.

    Measured: Baseline, 4 weeks and 8 weeks

  7. Functional Abilities Confidence Scale (FACS)

    The Functional Abilities Confidence Scale (FACS) will be used to measure the participant's self-efficacy regarding their ability to perform various physical activities and postures. This 15-item instrument requires participants to rate their level of confidence for each specific activity on a scale ranging from 0 (no confidence) to 100 (complete confidence). The total score is calculated by averaging the ratings across all items, yielding a final score between 0 and 100. Higher scores indicate a greater level of self-confidence in functional capabilities, which is a critical psychological factor influencing rehabilitation engagement and motor recovery in stroke survivors.

    Measured: Baseline, 4 weeks and 8 weeks

  8. Stroke Self-Efficacy Questionnaire (SSEQ)

    The Stroke Self-Efficacy Questionnaire (SSEQ) will be used to assess the participant's confidence in their ability to perform functional activities and manage self-care tasks following a stroke. This 13-item instrument covers two main domains: activity (related to functional independence) and self-management (related to coping with stroke consequences). Each item is rated on a 4-point ordinal scale ranging from 0 (not at all confident) to 3 (very confident), yielding a total score that ranges from 0 to 39. Higher scores indicate a higher level of self-efficacy, which is associated with better functional recovery and quality of life in stroke survivors.

    Measured: Baseline, 4 weeks and 8 weeks

  9. Daily Living Self-Efficacy Scale (DLSES)

    The Daily Living Self-Efficacy Scale (DLSES) will be used to assess the participant's confidence in their ability to function independently in daily life following a stroke. This 12-item instrument comprises two subscales: self-efficacy for activities of daily living and self-efficacy for psychosocial functioning. Participants rate their level of confidence for each specific task on an 11-point scale ranging from 0 (not confident at all) to 10 (completely confident). The total score is calculated by summing the responses, resulting in a range of 0 to 120, where higher scores indicate a greater level of self-efficacy in managing daily activities and psychosocial challenges. The DLSES is a psychometrically sound measure specifically validated for the stroke population.

    Measured: Baseline, 4 weeks and 8 weeks

  10. Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Chinese version

    The Chinese version of the Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) will be used to evaluate the participant's ability to perform visual and kinesthetic motor imagery. This 14-item instrument comprises two subscales: Visual Imagery (7 items) and Kinesthetic Imagery (7 items), covering movements of the upper and lower extremities as well as the trunk. For each item, the participant first physically executes a movement and then imagines performing it, rating the ease or difficulty of the mental image on a 7-point Likert scale ranging from 1 (very hard to see/feel) to 7 (very easy to see/feel). The total score ranges from 14 to 98, with subscale scores ranging from 7 to 49. Higher scores indicate superior motor imagery ability. The Chinese version of the MIQ-RS has demonstrated good reliability and validity specifically for the stroke population.

    Measured: Baseline, 4 weeks and 8 weeks

  11. The Embodiment Questionnaires

    The Embodiment Questionnaire will be used to evaluate the participant's subjective experience of embodiment towards the virtual or assisting limb during the intervention. This assessment specifically measures two primary domains: Sense of Ownership (the feeling that the virtual/observed limb belongs to the user) and Sense of Agency (the feeling that the user is generating and controlling the movements). Participants rate their agreement with a series of statements on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), or alternatively from -3 to +3 depending on the specific adaptation used. The scores are averaged for each domain, with higher scores indicating a stronger sense of embodiment, which is hypothesized to facilitate motor learning and neural reorganization in stroke rehabilitation.

    Measured: Baseline, 4 weeks and 8 weeks

  12. Electroencephalography (EEG)-Event-related desynchronization (ERD) of sensorimotor mu rhythm of both hemispheres

    Electroencephalography (EEG) will be used to assess cortical activation by measuring the Event-Related Desynchronization (ERD) of the sensorimotor mu rhythm (typically 8-13 Hz). Signals will be recorded from electrodes positioned over the sensorimotor cortex (e.g., C3 and C4 according to the international 10-20 system). ERD is calculated as the percentage decrease in the spectral power of the mu band during motor tasks relative to a resting baseline period, using the formula: (Task Power - Baseline Power) / Baseline Power × 100. The resulting values are expressed as percentages, where a more negative value (indicating greater suppression of the mu rhythm) reflects higher cortical excitability and engagement of the motor system during the task.

    Measured: Baseline, through study completion, an average of 1 year

  13. Electromyography (EMG) - intermuscular coherence (IMC) between both hands

    Surface Electromyography (sEMG) will be used to assess the functional coupling between motor units of the wrist extensor muscles through the analysis of Intermuscular Coherence (IMC). sEMG signals will be recorded during dynamic wrist extension tasks. IMC is calculated in the frequency domain, typically focusing on the beta band (15-30 Hz), to quantify the strength of common neural drive to the muscle pair, with values ranging from 0 (no coherence) to 1 (perfect coherence). Higher coherence values in the beta band generally indicate stronger corticospinal coupling and more synchronized motor unit firing, which are associated with better motor control and recovery following stroke.

    Measured: Baseline, through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start1 Aug 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Participant, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07426354
Sponsor's protocol ID
14-IRB040
Status last verified
Feb 2026
First submitted
3 Feb 2026
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect the privacy of stroke participants and adhere to the Institutional Review Board (IRB) guidelines, individual participant data (IPD) will not be made publicly available. The raw neurophysiological data (EEG/EMG) and clinical assessments are reserved for the research team to complete the primary and secondary analyses specified in the study protocol. However, de-identified aggregate results and study documents will be shared through peer-reviewed publications.

Questions about this trial

What is this clinical trial studying?

A study testing MAF-MT: Multimodal Augmeneted Mirror Therapy, Traditional Mirror Therapy and MVF-MT: Digital Mirror Visual Feedback Mirror Therapy in people with Stroke and Hemiparesis After Stroke, run by Asia University 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 5 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: enrolling by invitation, as of the sponsor's last update on 23 Feb 2026. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Fugl-Meyer Assessment of Upper Extremity (FMA-UE) (time frame: Baseline, 4 weeks, and 8 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 23 Feb 2026.

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