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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02254616
• Date of registration: 16/09/2014
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
• Scientific title: 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
• Date of first enrolment: August 1, 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02254616
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Ching-Yi Wu, ScD
• Affiliation: Chang Gung Memorial Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cerebrovascular Accident

Intervention(s)

Behavioral: Mirror Therapy with tDCS

Behavioral: Mirror Therapy

Behavioral: Mirror Therapy with sham-tDCS

Behavioral: Control Intervention

Primary Outcome(s)

Change scores of Fugl-Meyer Assessment (FMA) [Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks]

Change scores of Motor Activity Log (MAL) [Time Frame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks]

Change scores of Revised Nottingham Sensory Assessment (rNSA) [Time Frame: Baseline, and 4 weeks]

Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) [Time Frame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks]

Change scores of Wolf Motor Function Test (WMFT) [Time Frame: Baseline, 2 weeks, and 4 weeks]

Secondary Outcome(s)

Change scores of Actigraphy [Time Frame: Baseline, and 4 weeks]

Change scores of Kinematic analysis [Time Frame: Baseline, and 4 weeks]

Change scores of 10-Meter Walk Test (10MWT) [Time Frame: Baseline, 4 weeks]

Change scores of Adelaide Activities Profile (AAP) [Time Frame: Baseline, and 4 weeks, 16 weeks, and 28 weeks]

Change scores of hand strength [Time Frame: Baseline, 2 weeks, and 4 weeks]

Change scores of Stroop test [Time Frame: Baseline, and 4 weeks]

Change scores of pressure pain threshold [Time Frame: Baseline, and 4 weeks]

Secondary ID(s)

102-5696A3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors