Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
1 other identifier
interventional
24
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2017
CompletedFebruary 15, 2019
January 1, 2019
3 years
September 16, 2014
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change scores of Fugl-Meyer Assessment (FMA)
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks
Change scores of Wolf Motor Function Test (WMFT)
The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients (Wolf et al., 2005).
Baseline, 2 weeks, and 4 weeks
Change scores of Motor Activity Log (MAL)
The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish each of the 30 daily activities. The score of each item ranges from 0 to 5, and the higher scores indicate more frequently used or higher quality of movements. The clinimetric properties of the MAL in stroke patients have been validated (Uswatte, Taub, Morris, Light, \& Thompson, 2006).
Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. The reliability, validity, and responsiveness have been shown to be satisfactory in stroke patients.
Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
Change scores of Revised Nottingham Sensory Assessment (rNSA)
The rNSA includes tactile sensation, kinesthetic sensation, and stereognosis. The rNSA is reliable measure of sensory function in stroke patients. For tactile sensation, the patient will be asked to indicate whenever he or she feels the test sensation. For kinesthetic sensations, all 3 aspects of movement will be tested: appreciation of movement, its direction and accurate joint position sense. The limb on the affected side of the body will be supported and moved by the examiner in various directions but movement is only at one joint at a time. The patients will be asked to mirror the change of movement with the other limb. For stereognosis, the object will be placed in the patient's hand for a maximum of 30 seconds. Identification is by naming, description or by pair-matching with an identical set. The object may be moved around the affected hand by the examiner. The rNSA has good intrarater and interrater reliability (Lincoln, Jackson, \& Adams, 1998).
Baseline, and 4 weeks
Secondary Outcomes (7)
Change scores of Adelaide Activities Profile (AAP)
Baseline, and 4 weeks, 16 weeks, and 28 weeks
Change scores of 10-Meter Walk Test (10MWT)
Baseline, 4 weeks
Change scores of Actigraphy
Baseline, and 4 weeks
Change scores of Kinematic analysis
Baseline, and 4 weeks
Change scores of hand strength
Baseline, 2 weeks, and 4 weeks
- +2 more secondary outcomes
Study Arms (4)
Mirror therapy with tDCS
EXPERIMENTALFunctional 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.
Mirror Therapy
ACTIVE COMPARATORThe 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.
Control Intervention
ACTIVE COMPARATORThe 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.
Mirror Therapy with sham-tDCS
ACTIVE COMPARATORFunctional 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.
Interventions
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.
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.
The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.
The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Yong Cheng Rehabilitation Clinic
Taipei, 106, Taiwan
Xing Cheng Rehabilitation Clinic
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Lo-Sheng Sanatorium and Hospital
Taoyuan District, 333, Taiwan
Related Publications (1)
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.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-Yi Wu, ScD
Chang Gung Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
October 2, 2014
Study Start
August 1, 2014
Primary Completion
July 31, 2017
Study Completion
October 11, 2017
Last Updated
February 15, 2019
Record last verified: 2019-01