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

Chang Gung Medical Foundation

Status: Completed

Conditions: Cerebrovascular Accident

Treatments: Behavioral: Control Intervention; Behavioral: Mirror Therapy with tDCS; Behavioral: Mirror Therapy; Behavioral: Mirror Therapy with sham-tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02254616

102-5696A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First episode of stroke in cortical regions
• Time since stroke more than 6 months
• Initial motor part of UE of FMA score ranging from 24 to 52, indicating moderate to mild movement impairment
• No severe spasticity in any joints of the affected arm (Modified Ashworth Scale ≤ 2)
• No serious cognitive impairment (i.e., Mini Mental State Exam score≧ 24)
• Willing to sign the informed consent form.

Exclusion criteria

• Aphasia that might interfere with understanding instructions
• Visual/attention impairments that might interfere with the seeing of mirror illusion, including hemineglect/hemianopsia
• Major health problems or poor physical conditions that might limit participation
• Currently participation in any other research
• Previous brain neurosurgery
• Metallic implants within the brain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups

Mirror therapy with tDCS

Experimental group

Description:

Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.

Treatment:

Behavioral: Mirror Therapy with tDCS

Mirror Therapy

Active Comparator group

Description:

The MT only group will receive a 60-minute MT per session followed by a 30-minute functional training. Participant will go through the same protocol as that for the MT+tDCS and MT+sham tDCS groups with no tDCS presented in setting. This group is for evaluating placebo effect of the present of tDCS application.

Treatment:

Behavioral: Mirror Therapy

Control Intervention

Active Comparator group

Description:

The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training. During the 60-mimute conventional training, interventions will include passive range of movement and muscle tone normalization techniques of the affected arm, and gross motor training (e.g., shoulder ladder activity), fine motor training (e.g., grasping cones), and muscle strength training in a unilateral and bilateral manners. During the 30-minute functional training, the same principles to those in the MT groups will be applied.

Treatment:

Behavioral: Control Intervention

Mirror Therapy with sham-tDCS

Active Comparator group

Description:

Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.

Treatment:

Behavioral: Mirror Therapy with sham-tDCS