Cerebrovascular AccidentNCT02254616
Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
A study testing Mirror Therapy with tDCS and Mirror Therapy in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Mirror Therapy with tDCS and Mirror Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Aug 2014to 11 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Taiwan4 sites
Yong Cheng Rehabilitation Clinic
Taipei, 106
Xing Cheng Rehabilitation Clinic
Taipei
Chang Gung Memorial Hospital
Taoyuan, 333
Lo-Sheng Sanatorium and Hospital
Taoyuan, 333
About this study
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
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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- Mirror Therapy with tDCS, Mirror Therapy with sham-tDCS, Mirror Therapy, Control Intervention
- Keywords
- Stroke Rehabilitation, Hybrid therapy, Mirror Therapy, Transcranial Direct Current Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror Therapy with tDCSBehavioural
Also called MTtDCS
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.
Mirror Therapy with sham-tDCSBehavioural
Also called MTtDCS(m)
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.
Mirror TherapyBehavioural
Also called MT
The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.
Control InterventionBehavioural
Also called CI
The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy with tDCS | Experimental | 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. Receives: Behavioral: Mirror Therapy with tDCS |
| Mirror Therapy | Active comparator | 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. Receives: Behavioral: Mirror Therapy |
| Control Intervention | Active comparator | 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. Receives: Behavioral: Control Intervention |
| Mirror Therapy with sham-tDCS | Active comparator | 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. Receives: Behavioral: Mirror Therapy with sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Baseline, and 4 weeks
Secondary outcomes (7)
Change scores of Adelaide Activities Profile (AAP)
AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities. It scores on a scale of 0-3, with higher point meaning more frequent participation. The AAP is found to have good validity and reliability (Bond \& Clark, 1998). The Nottingham Extended Activities of Daily Living (NEADL) Scale (Nouri, \& Lincoln, 1987) is frequently used in clinical practice and research in rehabilitation to assess patients' independence in activities of daily living. Twenty-two activities are considered, which full in to 4 subscales: mobility, kitchen, domestic, and leisure activity. Responses are using 1 of 4 options (0 = not at all, 1 = with help, 2 = on my own with difficulty, 3 = on my own).
Measured: Baseline, and 4 weeks, 16 weeks, and 28 weeks
Change scores of 10-Meter Walk Test (10MWT)
The 10MWT assess mobility function by measuring the time and the numbers of strides required to walk 10 meters under two conditions: (1) with the self-pace of each participant (self-pace); (2) with the speed that the participants walked as soon as possible. The velocity and stride length of the participant are calculated. Research has validated the 10MWT in measuring mobility in stroke.
Measured: Baseline, 4 weeks
Change scores of Actigraphy
The activity monitors will be used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. This measure, quantitatively recording the amount of activity in free-living conditions, will be used to reflect increase in the amount of affected arm use over time. The participants will be asked to wear an activity monitor, Actigraphy (Ambulatory Monitoring Inc., New York), on each wrist for 3 consecutive days to measure what amount they actually do in their daily life before and immediately after treatment. The Actigraphy can be attached to the subject's limb and measures the motion of that limb through an accelerometer. In this project, acceleration will be sampled at 10 Hz and summed over a user-specified epoch. The recording epoch will be 2 seconds; recording capacity will be approximately 72 hours. The ratio of affected to non-affected arm movement is a reliable and valid real-life measure of treatment outcome.
Measured: Baseline, and 4 weeks
Change scores of Kinematic analysis
The kinematic analysis will involve unilateral and bilateral tasks, in which the participants will be asked to perform by using the affected upper limb or both upper limb simultaneously. A motion analysis system with 7 cameras (VICON MX 30d, Oxford Metrics Inc., Oxford, UK) will be used to capture the motion of arm (s) in kinematic testing. The markers will be attached on the styloid processes of the ulna. Depending on the unilateral or bilateral tasks, the makers will be placed on the affected arm or the both arms, respectively.
Measured: Baseline, and 4 weeks
Change scores of hand strength
The Baseline digital hydraulic hand dynamometer and pinch gauge (Fabrication Enterprises Inc, NY.) were used for measurement of grip and pinch strength. For the grip strength measurement, participants were instructed to squeeze the dynamometer with their hand as hard as they could. For the lateral pinch strength measurement, the pinch gauge was positioned between the pad of the thumb and the radial side of the middle phalanx of the index finger. For palmar pinch strength measurement, the pinch gauge was grasped between the pad of the thumb and the pad of the index finger. Participants were told to pinch as hard as they could. This method shows high repeatability (Haidar, Kumar, Bassi, \& Deshmukh, 2004).
Measured: Baseline, 2 weeks, and 4 weeks
Change scores of Stroop test
The Number Stroop Test of the Psychology Experiment Building Language (Mueller, \& Piper, 2014) was used to assess the inhibition ability. Participants will be asked to respond to the amount but not the name of stimuli.
Measured: Baseline, and 4 weeks
Change scores of pressure pain threshold
The Commander Algometer (JTECH Medical, USA) is designed for easy handling and fine resolution to identify clinically significant pain sensitivity changes. The Commander Algometer provides a convenient, efficient, objective pain evaluation tool for treatment planning, progress evaluation and case management. The measured pressure thresholds/tolerances and trigger point tenderness will be reported by patients.
Measured: Baseline, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start1 Aug 2014
- Primary completion31 Jul 2017
- Study completion11 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Yi Wu, ScD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254616
- Sponsor's protocol ID
- 102-5696A3
- Status last verified
- Jan 2019
- First submitted
- 16 Sep 2014
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02254616
- Acronym / sponsor ID
- 102-5696A3
- Conditions
- Cerebrovascular Accident
- Keywords
- Stroke Rehabilitation, Hybrid therapy, Mirror Therapy, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy with tDCS | Experimental | Behavioral: Mirror Therapy with tDCSFunctional 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 comparator | Behavioral: Mirror TherapyThe 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 comparator | Behavioral: Control InterventionThe 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 comparator | Behavioral: Mirror Therapy with sham-tDCSFunctional 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirror Therapy with tDCSAlso: MTtDCSThe 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. | Behavioural | Mirror therapy with tDCS |
| Mirror Therapy with sham-tDCSAlso: MTtDCS(m)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. | Behavioural | Mirror Therapy with sham-tDCS |
| Mirror TherapyAlso: MTThe MT group will receive a 60-minute MT per session followed by a 30-minute functional training. | Behavioural | Mirror Therapy |
| Control InterventionAlso: CIThe CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training. | Behavioural | Control Intervention |
Primary outcome
Change scores of Fugl-Meyer Assessment (FMA)
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks
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.
Change scores of Wolf Motor Function Test (WMFT)
Time frame: Baseline, 2 weeks, and 4 weeks
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).
Change scores of Motor Activity Log (MAL)
Time frame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
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).
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
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.
Change scores of Revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, and 4 weeks
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).
7 secondary outcomes
Change scores of Adelaide Activities Profile (AAP)
Time frame: Baseline, and 4 weeks, 16 weeks, and 28 weeks
Change scores of 10-Meter Walk Test (10MWT)
Time frame: Baseline, 4 weeks
Change scores of Actigraphy
Time frame: Baseline, and 4 weeks
Change scores of Kinematic analysis
Time frame: Baseline, and 4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 33175411Elsner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-Yi Wu, ScD principal investigator
Chang Gung Memorial Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy with tDCS and Mirror Therapy in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Fugl-Meyer Assessment (FMA) (time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02254616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.