NCT07426354

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. 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. 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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for not_applicable stroke

Timeline
31mo left

Started Aug 2025

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Aug 2025Dec 2028

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

February 3, 2026

Last Update Submit

February 15, 2026

Conditions

Keywords

neurorehabilitationmultimodal sensory feedback

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

EXPERIMENTAL
Behavioral: MAF-MT: Multimodal Augmeneted Mirror Therapy

MVF-MT: Digital Mirror Visual Feedback Mirror Therapy

ACTIVE COMPARATOR
Behavioral: MVF-MT: Digital Mirror Visual Feedback Mirror Therapy

TMT: Traditional Mirror Therapy

PLACEBO COMPARATOR
Behavioral: Traditional Mirror Therapy

Interventions

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.

MAF-MT: Multimodal Augmented Mirror Therapy

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

TMT: Traditional Mirror Therapy

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

MVF-MT: Digital Mirror Visual Feedback Mirror Therapy

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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.

Locations