Trial · NCT02254616
Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
NCT02254616, Not applicable, Completed, Chang Gung Memorial Hospital
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery. Trials, record NCT02254616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02254616
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery
- NCT number
- NCT02254616
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 24 participants, actual
- Lead sponsor
- Chang Gung Memorial Hospital
- Conditions
- Cerebrovascular Accident
- Interventions
- Mirror Therapy with tDCS, Mirror Therapy with sham-tDCS, Mirror Therapy, Control Intervention
- First posted
- 2014-10-02
- Last updated
- 2019-02-15
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change scores of Fugl-Meyer Assessment (FMA) | 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. |
| Primary | Change scores of Wolf Motor Function Test (WMFT) | 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). |
| Primary | Change scores of Motor Activity Log (MAL) | 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). |
| Primary | Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0) | 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. |
| Primary | Change scores of Revised Nottingham Sensory Assessment (rNSA) | 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). |
| Secondary | Change scores of Adelaide Activities Profile (AAP) | Baseline, and 4 weeks, 16 weeks, and 28 weeks | 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). |
| Secondary | Change scores of 10-Meter Walk Test (10MWT) | Baseline, 4 weeks | 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. |
| Secondary | Change scores of Actigraphy | Baseline, and 4 weeks | 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. |
| Secondary | Change scores of Kinematic analysis | Baseline, and 4 weeks | 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. |
| Secondary | Change scores of hand strength | Baseline, 2 weeks, and 4 weeks | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33175411 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Numerical Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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