Clinical trial NCT02254616: Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Stroke Rehabilitation
Hybrid therapy
Mirror Therapy
Transcranial Direct Current Stimulation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
measure: Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, and 4 weeks
Secondary outcomes:
measure: Change scores of Adelaide Activities Profile (AAP)
timeFrame: Baseline, and 4 weeks, 16 weeks, and 28 weeks
measure: Change scores of 10-Meter Walk Test (10MWT)
timeFrame: Baseline, 4 weeks
measure: Change scores of Actigraphy
timeFrame: Baseline, and 4 weeks
measure: Change scores of Kinematic analysis
timeFrame: Baseline, and 4 weeks
measure: Change scores of hand strength
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change scores of Stroop test
timeFrame: Baseline, and 4 weeks
measure: Change scores of pressure pain threshold
timeFrame: Baseline, and 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yong Cheng Rehabilitation Clinic
city: Taipei
country: Taiwan
facility: Xing Cheng Rehabilitation Clinic
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Lo-Sheng Sanatorium and Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.