Efficacy and Time Dependent Effects of Transcranial Direct Current Stimulation (tDCS) Combined With Mirror Therapy for Rehabilitation After Subacute and Chronic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Change scores of Fugl-Meyer Assessment (FMA)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This project is designed to investigate the intervention effects and time dependent effects of combining tDCS and MT in patients with subacute and chronic stroke.
Detailed Description
This project is also designed to investigate the optimal application timing of tDCS in combination with MT in patients with subacute and chronic stroke. Patients with subacute and chronic stroke will be recruited and randomized into one of the 3 groups: sequentially apply tDCS and MT group (SEQ), apply tDCS concurrently with MT group (CON), and MT with sham tDCS group (SHAM). All participants will receive 40 minutes of MT followed by 30 minutes of functional task training. For the participants in the SEQ group, 20 minutes of tDCS will be applied prior to MT, while tDCS will be applied concurrently with MT for the first 20 minutes in the CON group. As for the SHAM group, tDCS electrodes will be placed on the scalp without actual current output. The interventions will be carried out 90 minutes per day, 5 days per week, for 4 weeks. Behavioral outcomes will be assessed by blinded evaluators before, after, and 3 months post intervention. To study the possible interaction of treatment group and time of outcome evaluations, group (SEQ vs. CON vs. SHAM groups) × time (pretest vs. posttest vs. follow-up) repeated measures ANOVA will be performed. Additionally, the partial eta square (η2) will be calculated to determine the effect size of interest.
Investigators
Eligibility Criteria
Inclusion Criteria
- •experienced a first-ever unilateral stroke with stroke onset ≥ 1 week;
- •UE-FMA score between 18 and 56
- •able to follow instructions to perform the tasks (Mini Mental State Examination ≥ 24)
Exclusion Criteria
- •Participants are currently involved in other rehabilitation or drug research trial(s);
- •have neurological or psychological disorders other than stroke;
- •have joint contracture or excessive spasticity of the paretic upper limb that prohibits them performing the tasks;
- •received Botulinum toxin injections 3 months prior to enrollment
- •have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
- •have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body
- •have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.
Outcomes
Primary Outcomes
Change scores of Fugl-Meyer Assessment (FMA)
Time Frame: baseline, 1 month, 4 months
The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.
Secondary Outcomes
- Change scores of Adelaide Activities Profile (AAP)(baseline, 1 month)
- Change scores of 10-Meter Walk Test (10MWT)(baseline, 1 month)
- Change scores of Stroop test(baseline, 1 month)
- Change scores of pressure pain threshold(baseline, 1 month)
- Change scores of Dual-Task Block and Box Test(baseline, 1 month, 4 months)
- Change scores of Wolf Motor Function Test (WMFT)(baseline, 1 month)
- Change scores of Motor Activity Log (MAL)(baseline, 1 month, 4 months)
- Change scores of Actigraphy(baseline, 1 month)
- Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)(baseline, 1 month, 4 months)
- Change scores of MyotonPro(baseline, 1 month)
- Change scores of EuroQol (EQ)-5D questionnaire(baseline, 1 month)
- Change scores of Medical Research Council scale (MRC)(baseline, 1 month)
- Change scores of Modified Ashworth Scale (MAS)(baseline, 1 month)
- Change scores of Pinch and grasp dynamometer(baseline, 1 month)
- Change scores of The Facial Pain Scale-Revised (FPS-R )(baseline, 1 month)
- Change scores of Revised Nottingham Sensory Assessment (rNSA)(baseline, 1 month)
- Change scores of ABILHAND Questionnaire(baseline, 1 month, 4 months)
- Change scores of The Chedoke Arm and Hand Activity Inventory (CAHAI)(baseline, 1 month)
- Change scores of Modified Rankin Scale (mRS)(baseline, 1 month)
- Change scores of The short form of the Betts Questionnaire Upon Mental Imagery (Betts QMI)(baseline, 1 month)
- Change scores of The Facial Fatigue Scale-Revised (FFS-R)(baseline, 1 month)
- Change scores of Functional Independence Measure (FIM)(baseline, 1 month)
- Stroke Impact Scale Version 3.0 (SIS 3.0)(baseline, 1 month, 4 months)