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Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke

T

The Hong Kong Polytechnic University

Status

Unknown

Conditions

Stroke

Treatments

Behavioral: Standard mirror therapy
Behavioral: Enhanced mirror therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04749199
MT-fNIRSstudy

Details and patient eligibility

About

This research aims to test the methodological procedures and obtain preliminary results regarding the therapeutic and cost-effectiveness of enhanced mirror therapy relative to standard mirror therapy for improving brain reorganization and upper limb function in individuals with stroke.

Full description

Stroke is among the leading causes of mortality and disability, worldwide. Muscle weakness and other complications associated with stroke can result in decreased quality of life and significant declines in the activities of daily living. Mirror therapy has been shown to have a moderate effect, facilitating the functional recovery among individuals who have experienced a stroke. A prototype for a computerized, mirror therapy device was developed and found to be feasible. Recently, the investigators published a critical review and an activation likelihood estimation (ALE) meta-analysis analysing the widespread reports of brain activity associated with mirror therapy. Observations using functional near-infrared spectroscopy (fNIRS) to evaluate a group of people with stroke (n = 14) and healthy volunteers (n = 18) revealed that performing complex tasks during the mirror therapy paradigm enhanced top-down motor facilitation in the ipsilesional/ipsilateral hemisphere relative to the moving limb. An important next step in this series of studies is to evaluate the training effects associated with the performance of complex tasks during mirror therapy among stroke patients, using the designed computerized mirror therapy device to deliver the enhanced mirror therapy training. The results of this study will help the investigators to understand the underlying mechanisms through which mirror therapy facilitates motor rehabilitation and will add to the body of literature describing the best, evidence-based practices for mirror therapy during stroke rehabilitation. The investigators propose a pilot study (n = 30) to test the methodological procedures and obtain preliminary results for a fully powered, randomized, controlled trial (RCT), combined with economic evaluation, to compare the therapeutic and cost-effectiveness between standard mirror therapy and enhanced (complex task and blurred image) mirror therapy.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adults with stroke (40-75 years old), with normal or corrected-to-normal vision and hearing;
  • post-stroke duration of ≥ 6 months, before the start of data collection;
  • no severe deficits in memory, communication, or the ability to understand verbal instructions.

Exclusion criteria

  • participants with recurrent stroke; and
  • those who score < 24 on the Mini-Mental State Examination (MMSE).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Enhanced mirror therapy group
Experimental group
Description:
Participants in this group will perform complex and randomized finger opposition and reposition movements based on the training protocol, along with enhanced complexity and altered clarity of the displayed image.
Treatment:
Behavioral: Enhanced mirror therapy
Standard mirror therapy group
Sham Comparator group
Description:
Participants in this group will perform simple and sequential finger opposition and reposition movements, along with a clear image showing the exercising hand of the participants.
Treatment:
Behavioral: Standard mirror therapy

Trial contacts and locations

0

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Central trial contact

Stanley John Winser

Data sourced from clinicaltrials.gov

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