Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery

Recruiting

Phase N/A Results N/A

Trial Description

Contemporary behavior interventions focused on upper limb training such as robotic-assisted training and constraint-induced movement therapy have been proven to promote motor recovery. However, the improvement is often of limited in practical significance. Mirror therapy (MT) and transcranial direct current stimulation (tDCS) on brain based on similar principle of utilizing brain plasticity have shown benefits in promoting motor function recovery and are particularly easy to apply in different settings. tDCS activates a bulk of neural circuits in a non-specific way, coupling tDCS with MT could steer plastic process toward a functional direction. However, current evidence is insufficient to support the efficacy of tDCS as an adjuvant to upper limb training, and long-term effect has yet to be explored.
Cortical stimulation clearly has its role in stroke rehabilitation. However, current evidence is insufficient to support the efficacy of tDCS as an adjuvant to MT, and long-term effect has yet to be explored. Therefore, this randomized clinical trial will aim to examine (1) the beneficial effects of hybrid therapy (i.e., MT with tDCS) on health-related outcomes in patients with chronic stroke; (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 motor control and brain organization; (4) the correlations between brain excitability patterns and movement kinematics/health-related outcomes. Accordingly, we will compare the hybrid therapy vs MT with sham tDCS vs MT vs conventional intervention (CI) on motor performance, daily function, and activity participation. We will also examine underlying mechanisms by kinematic measures for motor control and fMRI analyses for brain reorganization. The MT with sham tDCS group is included to achieve a double-blinded design (patient and evaluator blinded) with the MT with real tDCS group. The MT only group is included to examine if there exist a placebo effect of the presence of tDCS setting in the MT with sham tDCS. The CI group is included to provide a baseline treatment to see if the other three therapies induce larger improvements compared to currently standard therapy. We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes. This study will be the first to investigate effects of the hybrid therapy, MT with tDCS, in chronic stroke. This study is unique in examining changes at different levels including motor performance, daily function, and activity participation, as well as brain and motor organization. To address the inconsistent benefits in daily function outcomes in previous research in MT and tDCS in stroke rehabilitation, we will modify the existing treatment protocols and include a 30-minute functional training into each treatment session in all groups. The result of this project might unveil a potentially better hybrid intervention for chronic stroke population to choose from, compared to a stand alone therapy such as MT and CI. And the result will also provide information on changes in motor control and brain organization which help understand the underlying mechanism. The follow-up examination will provide information on long term effect at the level of activity participation, which is crucial considering that chronic stroke patients are most likely living in community. In addition, we may provide critical information on the association between brain activity and movement patters/functional outcomes in terms of analyzing the correlation of fMRI data with hand kinematics/ health-related outcomes.

Detailed Description

Chronic stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 4 groups: MT+tDCS, MT+sham tDCS, MT, and CI groups. The participants in each group receive equivalent amounts of treatment.
Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately performed for each outcome measure to test the effects of different intervention groups.

Conditions

Interventions

  • Control intervention Other
    Intervention Desc: The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: Control Intervention
  • Mirror therapy Other
    Intervention Desc: The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: Mirror Therapy
  • Mirror Therapy with tDCS Behavioral
    Other Names: MTtDCS
    Intervention Desc: The MTtDCS group will receive a 20-minute tDCS at 1.5 mA current intensity per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: Mirror therapy with tDCS
  • Mirror Therapy with sham-tDCS Behavioral
    Other Names: MTtDCS(m)
    Intervention Desc: The MTtDCS(m) group will receive a 20-minute sham-tDCS per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.
    ARM 1: Kind: Experimental
    Label: Mirror therapy with sham-tDCS

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change scores of Fugl-Meyer Assessment (FMA) Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks No
Primary Change scores of Wolf Motor Function Test (WMFT) Baseline, 2 weeks, and 4 weeks No
Primary Change scores of Motor Activity Log (MAL) Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks No
Primary Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks No
Primary Change scores of Revised Nottingham Sensory Assessment (rNSA) Baseline, and 4 weeks No
Secondary Change scores of Adelaide Activities Profile (AAP) Baseline, and 4 weeks, 16 weeks, and 28 weeks No
Secondary Change scores of 10-Meter Walk Test (10MWT) Baseline, 4 weeks No
Secondary Change scores of Actigraphy Baseline, and 4 weeks No
Secondary Change scores of Kinematic analysis Baseline, and 4 weeks No
Secondary Change scores of hand strength Baseline, 2 weeks, and 4 weeks No
Secondary Change scores of Stroop test Baseline, and 4 weeks No
Secondary Change scores of pressure pain threshold Baseline, and 4 weeks No

Sponsors