Multimodal Sensory Feedback and Mirror Therapy for Stroke Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MAF-MT: Multimodal Augmeneted Mirror Therapy, Traditional Mirror Therapy, MVF-MT: Digital Mirror Visual Feedback Mirror Therapy.
- Who it may be relevant to
- Registry conditions: Stroke, Hemiparesis After Stroke. Basic parameters: 20 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neural Mechanisms and Efficacy of Multimodal Sensory Feedback Augmentation on Mirror Therapy for Stroke Rehabilitation
Overview
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
- Behavioral MAF-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. - Behavioral Traditional Mirror Therapy
TMT uses traditional mirror boxes to provide the mirror visual feedback of the less affected hand during mirror therapy - Behavioral MVF-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
Primary outcome measures
- Fugl-Meyer Assessment of Upper Extremity (FMA-UE) [Time frame: Baseline, 4 weeks, and 8 weeks]
Secondary outcome measures (12)
- Wolf Motor Function Test (WMFT) [Time frame: Baseline, 4 weeks and 8 weeks]
- Modified Ashworth Scale (MAS) [Time frame: Baseline, 4 weeks and 8 weeks]
- Medical Research Council scale (MRC) [Time frame: Baseline, 4 weeks and 8 weeks]
- Nottingham Extended Activities of Daily Living Scale (NEADL) [Time frame: Baseline, 4 weeks and 8 weeks]
- The Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL) [Time frame: Baseline, 4 weeks and 8 weeks]
- EQ-5D-5L [Time frame: Baseline, 4 weeks and 8 weeks]
- Functional Abilities Confidence Scale (FACS) [Time frame: Baseline, 4 weeks and 8 weeks]
- Stroke Self-Efficacy Questionnaire (SSEQ) [Time frame: Baseline, 4 weeks and 8 weeks]
- Daily Living Self-Efficacy Scale (DLSES) [Time frame: Baseline, 4 weeks and 8 weeks]
- Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Chinese version [Time frame: Baseline, 4 weeks and 8 weeks]
- The Embodiment Questionnaires [Time frame: Baseline, 4 weeks and 8 weeks]
- Electroencephalography (EEG)-Event-related desynchronization (ERD) of sensorimotor mu rhythm of both hemispheres [Time frame: Baseline, through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Tzu Chi Hospital — New Taipei City
Identifiers
NCT: NCT07426354 · 14-IRB040