Multimodal Sensory Feedback and Mirror Therapy for Stroke Rehabilitation
Neural Mechanisms and Efficacy of Multimodal Sensory Feedback Augmentation on Mirror Therapy for Stroke Rehabilitation
1 other identifier
interventional
84
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2025
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 3, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 23, 2026
February 1, 2026
3.4 years
February 3, 2026
February 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline, 4 weeks, and 8 weeks
Secondary Outcomes (13)
Wolf Motor Function Test (WMFT)
Baseline, 4 weeks and 8 weeks
Modified Ashworth Scale (MAS)
Baseline, 4 weeks and 8 weeks
Medical Research Council scale (MRC)
Baseline, 4 weeks and 8 weeks
Nottingham Extended Activities of Daily Living Scale (NEADL)
Baseline, 4 weeks and 8 weeks
The Lawton-Brody Instrumental Activities of Daily Living Scale (Lawton-Brody IADL)
Baseline, 4 weeks and 8 weeks
- +8 more secondary outcomes
Study Arms (3)
MAF-MT: Multimodal Augmented Mirror Therapy
EXPERIMENTALMVF-MT: Digital Mirror Visual Feedback Mirror Therapy
ACTIVE COMPARATORTMT: Traditional Mirror Therapy
PLACEBO COMPARATORInterventions
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.
TMT uses traditional mirror boxes to provide the mirror visual feedback of the less affected hand during mirror therapy
MVF-MT provides real-time digital image of the less affected hand as the mirror visual feedback during mirror therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asia Universitylead
Study Sites (1)
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 23, 2026
Study Start
August 1, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
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.