Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery---A Follow up Study on Brain Reorganization, Motor Performance of Upper Extremity, Daily Function, and Activity Participation

The purpose of this randomized controlled trial will be to examine (1) the effects of a hybrid therapy (ie, mirror therapy combined with transcranial direct current stimulation, MT+ tDCS) on health-related outcomes in patients with chronic stroke from pre- to post-treatment; (2) the long-term benefits of the hybrid therapy on activity participation at 6-month follow-up; (3) the underlying mechanisms of the hybrid therapy on brain organization and motor control; and (4) the correlations between brain excitability patterns and movement kinematics as well as health-related outcomes. To achieve the aims, we will study the effects of MT combined with tDCS compared to MT with sham tDCS, MT alone, and conventional intervention (CI) on motor performance, daily function, and activity participation. We will also examine the underlying mechanism of change in brain plasticity and motor control by functional magnetic resonance imaging (fMRI) analyses and kinematic analysis, respectively. Contemporary approaches to upper limb motor rehabilitation such as robot-assisted therapy and constraint-induced therapy are effective for reducing motor impairments but are limited by practical constraints. These therapies either require intensive engagement or are expensive to apply in clinical settings. MT is inexpensive and applicable in clinical settings. This regimen is versatile for clinical use because of its compatibility with adjunct procedures such as somatosensory stimulation and transcranial stimulation. MT and tDCS are both based upon principles of rehabilitation for inducing neuroplastic change. Both regimens have been shown to be effective for promoting motor recovery after stroke. tDCS does not require patients’ efforts and can be used to activate a bulk of neural circuits in a non-specific way. Coupling tDCS with MT could steer plastic process toward greater functional recovery. Current evidence is insufficient to support the efficacy of tDCS as an adjuvant to upper limb intervention. In addition, long-term effects of the hybrid therapy have yet to be explored. At least 80 participants with chronic stroke will be recruited and randomly assigned to one of 4 groups: MT with tDCS, MT with sham tDCS, MT only, and CI. All the interventions will be implemented 90 minutes/day, 5 days/week, for 4 weeks. MT with real and sham tDCS groups will receive 60-minute MT with concurrent real or shame tDCS during the first 30 minutes, and then followed by 30-minute functional training. The MT group will receive 60-minute MT, followed by 30-minute functional training. The CI group will receive 60-minute conventional rehabilitation followed by 30-minute functional task practice. Outcome measures of sensorimotor function will include Fugl-Meyer Assessment and Revised Nottingham Sensory Assessment. Motor and daily functions, and activity participation will be assessed based on Wolf Motor Function Test, Motor Activity Log (MAL), Reintegration to Normal Living Index (RNLI), and Adelaide Activities Profile (AAP). Brain reorganization and motor control strategy will be assessed by fMRI study and kinematic analysis. Evaluators will be blinded to group allocation. A 6-month follow-up will be conducted for the re-evaluation of MAL, RNLI, and AAP. This study is unique in investigating the effects of the hybrid therapy (MT+tDCS) using a placebo-controlled trial. This research will be the first to study multiple treatment endpoints that correspond to different levels of functional outcomes, as well as brain and movement organization. The result of this research may shed light on the additive benefits of combinatory treatment relative to the stand-alone therapy. The follow-up examination will provide information on the retention or dilution of treatment effect on daily functions and activity participation, which are crucial for community reentry. Study of brain activity and movement pattern control may have implications for mechanism of change after treatment. Results of this research may lead to refined protocols of combinatory treatment based on MT and electrical stimulations.

Project ID:PC10501-1383
External Project ID:MOST103-2314-B182-004-MY3