Stroke, Hemiparesis After Stroke
Conditions
Keywords
neurorehabilitation, multimodal sensory feedback
Brief 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. 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
Interventions
BEHAVIORALMAF-MT: Multimodal Augmeneted Mirror Therapy
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.
BEHAVIORALTraditional Mirror Therapy
TMT uses traditional mirror boxes to provide the mirror visual feedback of the less affected hand during mirror therapy
BEHAVIORALMVF-MT: Digital Mirror Visual Feedback Mirror Therapy
MVF-MT provides real-time digital image of the less affected hand as the mirror visual feedback during mirror therapy
Sponsors
Asia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of Upper Extremity (FMA-UE) | Baseline, 4 weeks, and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test (WMFT) | Baseline, 4 weeks and 8 weeks | 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. |
| Modified Ashworth Scale (MAS) | Baseline, 4 weeks and 8 weeks | 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. |
| Medical Research Council scale (MRC) | Baseline, 4 weeks and 8 weeks | 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. |
| Nottingham Extended Activities of Daily Living Scale (NEADL) | Baseline, 4 weeks and 8 weeks | 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. |
| The Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL) | Baseline, 4 weeks and 8 weeks | 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. |
| EQ-5D-5L | Baseline, 4 weeks and 8 weeks | 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. |
| Functional Abilities Confidence Scale (FACS) | Baseline, 4 weeks and 8 weeks | 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. |
| Stroke Self-Efficacy Questionnaire (SSEQ) | Baseline, 4 weeks and 8 weeks | 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. |
| Daily Living Self-Efficacy Scale (DLSES) | Baseline, 4 weeks and 8 weeks | 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. |
| Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Chinese version | Baseline, 4 weeks and 8 weeks | 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. |
| The Embodiment Questionnaires | Baseline, 4 weeks and 8 weeks | 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. |
| Electroencephalography (EEG)-Event-related desynchronization (ERD) of sensorimotor mu rhythm of both hemispheres | Baseline, through study completion, an average of 1 year | 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. |
| Electromyography (EMG) - intermuscular coherence (IMC) between both hands | Baseline, through study completion, an average of 1 year | 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. |
Countries
Taiwan
Outcome results
None listed