Clinical trial NCT04749199: Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke
Official title: Enhanced Mirror Therapy for Improving Brain Reorganization and Function in Stroke: A Pilot Randomized Controlled Trial With Economic Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Mirror therapy
Stroke
Hand function
Cost-effectiveness
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: University of Canterbury
name: National University of Singapore
First posted: 2021-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Blood oxygenated haemoglobin concentrations
timeFrame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Secondary outcomes:
measure: Wrist and hand function
timeFrame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
measure: Upper limb function
timeFrame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
measure: Economic evaluation
timeFrame: Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2)
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Polytechnic University
name: Stanley John Winser
role: PRINCIPAL_INVESTIGATOR
References: