Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke

NCT04749199 | Unknown

• 1 other identifier: MT-fNIRSstudy
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

Mirror therapy; Stroke; Hand function; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Blood oxygenated haemoglobin concentrations

  Functional near-infrared spectroscopy (fNIRS) will be used to assess neurovascular changes (blood oxygenated haemoglobin concentrations) in the M1. Higher the score obtained indicate better facilitation of the primary motor cortex.

  Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)

Secondary Outcomes (3)

• Wrist and hand function

  Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)

• Upper limb function

  Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)

• Economic evaluation

  Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)

Study Arms (2)

Enhanced mirror therapy group

EXPERIMENTAL

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.

Behavioral: Enhanced mirror therapy

Standard mirror therapy group

SHAM COMPARATOR

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.

Behavioral: Standard mirror therapy

Interventions

Enhanced mirror therapy 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.

Also known as: Complex task mirror therapy

Enhanced mirror therapy group

Standard mirror therapy 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.

Also known as: Simple task mirror therapy

Standard mirror therapy group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• University of Canterbury: collaborator
• National University of Singapore: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stanley John Winser

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley John Winser

CONTACT

27666746; stanley.j.winser@polyu.edu.hk

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A blinded assessor and statistician will evaluate a two-arm, parallel-group, RCT that compares enhanced mirror therapy, comprised of increased task complexity and mirror image blurriness, with standard mirror therapy training among 30 participants with chronic stroke.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: February 11, 2021
• Study Start: May 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: November 1, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02