Stroke
Conditions
Keywords
Mirror therapy, Stroke, Hand function, Cost-effectiveness
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.
Interventions
BEHAVIORALEnhanced 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.
BEHAVIORALStandard 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.
Sponsors
University of Canterbury
National University of Singapore
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood oxygenated haemoglobin concentrations | Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrist and hand function | Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2) | The Fugl-Meyer assessment (wrist and hand subcomponents) for the assessment of the upper limb function. The scale has a maximum score of 66 and a minimum of 34 with higher the score obtained better the wrist and hand function. |
| Upper limb function | Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2) | The Action Research Arm Test (ARAT), to assess upper-limb function. The ARAT scores range from 0-57, with a maximum score of 57 points indicating better performance of the upper limb. |
| Economic evaluation | Change in score at the end of 4-weeks of intervention (T1), and six months post-intervention (T2) | The Euro quality of life (EuroQol, 5 dimensions and 5 levels 62) survey, will assess the quality-adjusted life years (QALY) for the cost-effectiveness estimation. The EQ-5D-5L response will be converted into utility scores, which will be used to estimate gains or losses in quality-adjusted life-years (QALYs) over the follow-up period. The higher the score obtained better the quality-life-adjusted-years due to the intervention. |
Contacts
Primary ContactStanley John Winser
Outcome results
None listed