Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke

NCT ID: NCT04749199

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-11-01

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Enhanced mirror therapy group

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.

Group Type: EXPERIMENTAL

Enhanced mirror therapy

Intervention Type: BEHAVIORAL

Participants of the enhanced mirror therapy group will perform complex, randomized, finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a 35% blurred visual feedback through the computerized mirror therapy device. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.

Standard mirror therapy group

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.

Group Type: SHAM_COMPARATOR

Standard mirror therapy

Intervention Type: BEHAVIORAL

Participants allocated to this group will perform simple, sequential finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a clear image of the exercising hand. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.

Interventions

Enhanced mirror therapy

Participants of the enhanced mirror therapy group will perform complex, randomized, finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a 35% blurred visual feedback through the computerized mirror therapy device. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.

Intervention Type: BEHAVIORAL

Standard mirror therapy

Participants allocated to this group will perform simple, sequential finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a clear image of the exercising hand. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.

Intervention Type: BEHAVIORAL

Other Intervention Names

Complex task mirror therapy; Simple task mirror therapy

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Canterbury

OTHER

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Stanley John Winser

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanley John Winser

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Central Contacts

Stanley John Winser

Role: CONTACT

stanley.j.winser@polyu.edu.hk

27666746

Other Identifiers

MT-fNIRSstudy

Identifier Type: -

Identifier Source: org_study_id