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UnknownNCT04749199

Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke

Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke: A Pilot Randomized Controlled Trial With Economic Evaluation

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
The Hong Kong Polytechnic University · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALEnhanced mirror therapyParticipants 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.
BEHAVIORALStandard mirror therapyParticipants 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.

Timeline

Start date
2021-05-01
Primary completion
2021-12-01
Completion
2022-11-01
First posted
2021-02-11
Last updated
2021-02-15

Source: ClinicalTrials.gov record NCT04749199. Inclusion in this directory is not an endorsement.

Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke (NCT04749199) · Clinical Trials Directory