Cerebrovascular AccidentNCT04326205
Neural Mechanisms and Efficacy of Dual Neurotechnology-aided Mirror Therapy in Chronic Stroke: Neural and Motor Plasticity, Movement Performance, Daily Function, and Quality of Life
A study testing transcranial direct current stimulation, tDCS, functional electrical stimulation, FES and no stimulation in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Mirror therapy (MT) has been demonstrated, in terms of neuroplasticity, to improve sensorimotor function of paretic upper extremity (UE) in chronic stroke patients. Central and peripheral electrical stimulation techniques such as ranscranial direct current stimulation (tDCS) and functional electrical stimulation (FES)… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- transcranial direct current stimulation, tDCS, functional electrical stimulation, FES and no stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Apr 2021to 31 Jul 2023
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sustained a unilateral stroke with onset ≥ 3 months (Figlewski et al., 2017);
- UE Fugl-Meyer assessment (UE-FMA) score between 18 and 56 indicating mild to moderate mild motor severity (Menezes et al., 2018; Woodbury, Velozo, Richards, \& Duncan, 2013);
- aged 35 to 85 years old; and
- able to follow instructions and perform the tasks (Mini Mental State Examination ≥24).
Who cannot join
- with excessive spasticity or joint contracture of the paretic UE;
- enrolled in other rehabilitation experiments or drug studies;
- with additional neurological or psychological disorders other than stroke;
- having received Botulinum toxin injections 3 months before enrollment;
- having unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
- having contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body (not including dental fillings or hardware)(Meeker et al., 2019; Rossi, Hallett, Rossini, Pascual-Leone, \& Group, 2009);
- having a history of drug or alcohol abuse, dermatosis preventing tDCS from being applied, brain tumor, brain injury, arteriovenous malformation, other brain diseases (such as intracranial hypertension or cerebral edema), or are not suitable for using tDCS by the physician's assessment; and (8) having existence of skin rash, allergy or wounds at the locations where stimulation electrodes would be placed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan City, 333
Ching-Yi Wu, ScD, 886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw
About this study
Mirror therapy (MT) has been demonstrated, in terms of neuroplasticity, to improve sensorimotor function of paretic upper extremity (UE) in chronic stroke patients. Central and peripheral electrical stimulation techniques such as ranscranial direct current stimulation (tDCS) and functional electrical stimulation (FES) can individually enhance effects of MT, combining both of them with MT can be a potentially valuable approach to maximize neural and functional recovery post stroke. To our knowledge, no studies combined central and peripheral neural network reorganization technique with motor behavioral learning approach to investigate its possible benefit after stroke. This project will be the first to design a "dual neurotechnology-aided MT (DNA-MT)", which combines tDCS and FES with contemporary neurorehabilitation approaches (i.e., MT) to stimulate both central and peripheral nervous systems to maximize neural and functional recovery post stroke. Investigators will determine the efficacy and neurophysiological and motor mechanisms related to this novel DNA-MT approach and identify potential responders to this novel intervention.
- Conditions
- Cerebrovascular Accident
- Being tested
- transcranial direct current stimulation, tDCS, functional electrical stimulation, FES, no stimulation
- Keywords
- mirror therapy, transcranial direct current stimulation, functional electrical stimulation, neurotechnology-aided intervention, stroke, neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation, tDCSDevice
The participants will receive a-tDCS over the ipsilesional M1, without any active arm practice for 20 minutes.
Hence, movement extension will be achieved in the affected side while the participant will view the reflection of the normal movement patterns of their unaffected UE. Then the electrodes will be removed, and the participants will receive an additional 20 minutes of MT without tDCS followed by 30 minutes of functional task practice.
functional electrical stimulation, FESDevice
The participants will start the FES-assisted MT. During this period, participants will perform simple wrist or finger extension with their unaffected UE while the affected wrist or fingers will receive FES within the mirror-box.
Hence, movement extension will be achieved in the affected side while the participant will view the reflection of the normal movement patterns of their unaffected UE. Then the electrodes will be removed, and the participants will receive an additional 20 minutes of MT without FES followed by 30 minutes of functional task practice.
no stimulationOther
Both tDCS and FES will not be used in this section.
| Study group | Role | What they receive |
|---|---|---|
| Dual-aided | Experimental | active tDCS to the ipsilesional primary motor cortex (M1lesioned) followed by FES to the paretic hand during MT Receives: Device: transcranial direct current stimulation, tDCS; Device: functional electrical stimulation, FES |
| FES-alone | Active comparator | sham tDCS to the M1lesioned followed by FES to the paretic hand during MT Receives: Device: functional electrical stimulation, FES |
| tDCS-alone | Active comparator | active tDCS to the M1lesioned followed by sham FES to the paretic hand during MT Receives: Device: transcranial direct current stimulation, tDCS |
| Dual-sham | Placebo comparator | sham tDCS to the M1lesioned followed by sham FES to the paretic hand during M Receives: Other: no stimulation |
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 UE-FMA subscale is one of the most widely used tools to assess UE sensorimotor impairment in patients after stroke (Fugl-Meyer, Jääskö, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). The UE-FMA subscale examines 33 movements scored on a 3-point ordinal scale (score range: 0-66). A higher UE-FMA score suggests less impairment. The UE-FMA has good to excellent clinimetric properties e.
Measured: Baseline, 3 months, 6 months
Change scores of Modified Ashworth Scale (MAS)
The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Investigators will assess the MAS scores of UE muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors. The validity and reliability of MAS for patients with stroke are adequate to good (Gregson et al., 2000; Min et al., 2012).
Measured: Baseline, 3 months, 6 months
Change scores of Revised Nottingham Sensory Assessment (rNSA)
The rNSA will be used to evaluate changes in sensation in response to training (Lincoln et al., 1991; Lincoln, Jackson, \& Adams, 1998). Various sensory modalities will be used to assess tactile sensation, proprioception, and stereognosis of different segments of the body. Scoring of rNSA is based on a 3-point ordinal scale (0-2), with a lower score suggesting greater sensory impairment. The psychometric properties have been established for patients with stroke (Gaubert \& Mockett, 2000; Lincoln et al., 1998).
Measured: Baseline, 3 months, 6 months
Change scores of Dual-Task Test
Investigators will use the dual-task test to determine the ability of participants with stroke to perform 2 tasks at the same time. The dual-task test evaluates an individual's attentional limitation, central executive function, and automatic processing ability (Plummer-D'Amato et al., 2008). The primary task will be the box and block test (BBT) assessed with a wooden box containing 2 equally sized compartments. Cubes will be placed in 1 compartment, and the participants will be instructed to use their paretic hand to transport the cubes to the other compartment 1-by-1 in their fastest speed. The number of cubes moved within 60 seconds will be recorded. While performing the BBT, the participants will be required to perform a secondary task - counting backward by 7 or responding as fast as possible to different tones.
Measured: Baseline, 3 months, 6 months
Change scores of Medical Research Council scale (MRC)
The MRC is an ordinal scale that assesses muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates stronger muscle. The reliability of MRC for all muscle groups was good to excellent in patients with stroke (Gregson et al., 2000).
Measured: Baseline, 3 months, 6 months
Change scores of Montreal Cognitive Assessment (MoCA)
It is a 30-point test, which evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space (Nasreddine et al., 2005). The MoCA has been recommended as a valid and reliable clinical assessment in patients with stroke (Wong et al., 2013).
Measured: Baseline, 3 months, 6 months
Change scores of Wolf Motor Function Test (WMFT)
The WMFT was developed by Wolf and colleagues to quantitatively assess UE motor ability via 15 function-based tasks and 2 strength-based tasks. The WMFT-time measures the time required to complete the tasks, and the WMFT-quality assesses functional ability on a 6-point ordinal scale. A lower WMFT-time performance indicates faster movement, whereas a higher WMFT-quality score suggests better quality of movement (Wolf, Lecraw, Barton, \& Jann, 1989). The reliability of the WMFT is excellent (Wolf et al., 2001).
Measured: Baseline, 3 months, 6 months
Change scores of Motor Activity Log (MAL)
The MAL is a semi-structured interview to evaluate the amount of use (AOU) and quality of movement (QOM) of the paretic UE for patients with stroke. The MAL involves 30 functional tasks of daily living, including object manipulation and gross motor activities. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality (Taub et al., 1993). The responsiveness, validity, and reliability have been investigated in patients with stroke (Van der Lee, Beckerman, Knol, De Vet, \& Bouter, 2004).
Measured: Baseline, 3 months, 6 months
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
The NEADL is a self-report scale that measures instrumental activities of daily living. It evaluates 4 areas of daily living, including mobility, kitchen, domestic, and leisure activities. The total score is 0 to 66, and a higher score indicates better daily functional ability. The psychometric properties of NEADL have been well established (Green \& Young, 2001; Wu, Chuang, Lin, \& Hong, 2011).
Measured: Baseline, 3 months, 6 months
Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
Health-related quality of life will be evaluated with the SIS 3.0. The SIS consists of 59 test items grouped into 8 domains (strength, hand function, ADL/instrumental ADL, mobility, communication, emotion, memory and thinking, and participation/role function). The participants will be asked to rate each item in a 5-point Likert scale regarding the perceived difficulty in completing the task. The total score for each domain ranges from 0 to 100. An extra question will be asked to evaluate the participant's self-perceived overall recovery from stroke. The SIS 3.0 has satisfactory psychometric properties (Duncan, Bode, Lai, Perera, \& Investigators, 2003; Vellone et al., 2015).
Measured: Baseline, 3 months, 6 months
Change scores of Functional Abilities Confidence Scale (FACS)
It measures the degree of self-efficacy and confidence when the participants do various movements and postures. It concludes 15 questions which scores from 0% (not confidence at all) to 100% (fully confidence). The higher percentage means the higher confidence of doing the movements. The clinimetric properties are good (Williams \& Myers, 1998).
Measured: Baseline, 3 months, 6 months
Change scores of Stroke Self-Efficacy Questionnaire (SSEQ)
It measures the self-efficacy judgements in specific domains in relation to functional performance and self-management for stroke. It includes 13 items, which rates on a 10-point scale from 0 (not at all confident) to 10 (very confident). In addition, its psychometric testing is a valid measurement for stroke (Jones, Partridge, \& Reid, 2008).
Measured: Baseline, 3 months, 6 months
Change scores of Daily Living Self-Efficacy Scale (DLSES)
DLSES measures the self-efficacy in daily functions which contains 2 subscales (psychosocial functioning and activities of daily living). It has 12 items, with 10-unit intervals from 0 to 100 (0 = cannot do at all, 100 = highly certain can do). The total score is to sum up the scores of 12 items and is divided by 12. The higher score means higher self-efficacy and the psychometric properties are good (Maujean, Davis, Kendall, Casey, \& Loxton, 2014).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start14 Apr 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (estimated)
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
- NCT04326205
- Sponsor's protocol ID
- 201902241A0
- Status last verified
- May 2021
- First submitted
- 22 Mar 2020
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms and Efficacy of Dual Neurotechnology-aided Mirror Therapy in Chronic Stroke: Neural and Motor Plasticity, Movement Performance, Daily Function, and Quality of Life
- ClinicalTrials.gov ID
- NCT04326205
- Acronym / sponsor ID
- 201902241A0
- Conditions
- Cerebrovascular Accident
- Keywords
- mirror therapy, transcranial direct current stimulation, functional electrical stimulation, neurotechnology-aided intervention, stroke, neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 30 Mar 2020 (actual)
- 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.
Mirror therapy (MT) has been demonstrated, in terms of neuroplasticity, to improve sensorimotor function of paretic upper extremity (UE) in chronic stroke patients. Central and peripheral electrical stimulation techniques such as ranscranial direct current stimulation (tDCS) and functional electrical stimulation (FES) can individually enhance effects of MT, combining both of them with MT can be a potentially valuable approach to maximize neural and functional recovery post stroke. To our knowledge, no studies combined central and peripheral neural network reorganization technique with motor behavioral learning approach to investigate its possible benefit after stroke. This project will be the first to design a "dual neurotechnology-aided MT (DNA-MT)", which combines tDCS and FES with contemporary neurorehabilitation approaches (i.e., MT) to stimulate both central and peripheral nervous systems to maximize neural and functional recovery post stroke. Investigators will determine the efficacy and neurophysiological and motor mechanisms related to this novel DNA-MT approach and identify potential responders to this novel intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dual-aided | Experimental | Device: transcranial direct current stimulation, tDCS, Device: functional electrical stimulation, FESactive tDCS to the ipsilesional primary motor cortex (M1lesioned) followed by FES to the paretic hand during MT |
| FES-alone | Active comparator | Device: functional electrical stimulation, FESsham tDCS to the M1lesioned followed by FES to the paretic hand during MT |
| tDCS-alone | Active comparator | Device: transcranial direct current stimulation, tDCSactive tDCS to the M1lesioned followed by sham FES to the paretic hand during MT |
| Dual-sham | Placebo comparator | Other: no stimulationsham tDCS to the M1lesioned followed by sham FES to the paretic hand during M |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- sustained a unilateral stroke with onset ≥ 3 months (Figlewski et al., 2017);
- UE Fugl-Meyer assessment (UE-FMA) score between 18 and 56 indicating mild to moderate mild motor severity (Menezes et al., 2018; Woodbury, Velozo, Richards, \& Duncan, 2013);
- aged 35 to 85 years old; and
- able to follow instructions and perform the tasks (Mini Mental State Examination ≥24).
Key exclusion criteria (7 listed)
- with excessive spasticity or joint contracture of the paretic UE;
- enrolled in other rehabilitation experiments or drug studies;
- with additional neurological or psychological disorders other than stroke;
- having received Botulinum toxin injections 3 months before enrollment;
- having unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
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 |
|---|---|---|
| transcranial direct current stimulation, tDCSThe participants will receive a-tDCS over the ipsilesional M1, without any active arm practice for 20 minutes. Hence, movement extension will be achieved in the affected side while the participant will view the reflection of the normal movement patterns of their unaffected UE. Then the electrodes will be removed, and the participants will receive an additional 20 minutes of MT without tDCS followed by 30 minutes of functional task practice. | Device | Dual-aided, tDCS-alone |
| functional electrical stimulation, FESThe participants will start the FES-assisted MT. During this period, participants will perform simple wrist or finger extension with their unaffected UE while the affected wrist or fingers will receive FES within the mirror-box. Hence, movement extension will be achieved in the affected side while the participant will view the reflection of the normal movement patterns of their unaffected UE. Then the electrodes will be removed, and the participants will receive an additional 20 minutes of MT without FES followed by 30 minutes of functional task practice. | Device | Dual-aided, FES-alone |
| no stimulationBoth tDCS and FES will not be used in this section. | Other | Dual-sham |
Primary outcome
Change scores of Fugl-Meyer Assessment (FMA)
Time frame: Baseline, 3 months, 6 months
The UE-FMA subscale is one of the most widely used tools to assess UE sensorimotor impairment in patients after stroke (Fugl-Meyer, Jääskö, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). The UE-FMA subscale examines 33 movements scored on a 3-point ordinal scale (score range: 0-66). A higher UE-FMA score suggests less impairment. The UE-FMA has good to excellent clinimetric properties e.
Change scores of Modified Ashworth Scale (MAS)
Time frame: Baseline, 3 months, 6 months
The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Investigators will assess the MAS scores of UE muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors. The validity and reliability of MAS for patients with stroke are adequate to good (Gregson et al., 2000; Min et al., 2012).
Change scores of Revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, 3 months, 6 months
The rNSA will be used to evaluate changes in sensation in response to training (Lincoln et al., 1991; Lincoln, Jackson, \& Adams, 1998). Various sensory modalities will be used to assess tactile sensation, proprioception, and stereognosis of different segments of the body. Scoring of rNSA is based on a 3-point ordinal scale (0-2), with a lower score suggesting greater sensory impairment. The psychometric properties have been established for patients with stroke (Gaubert \& Mockett, 2000; Lincoln et al., 1998).
Change scores of Dual-Task Test
Time frame: Baseline, 3 months, 6 months
Investigators will use the dual-task test to determine the ability of participants with stroke to perform 2 tasks at the same time. The dual-task test evaluates an individual's attentional limitation, central executive function, and automatic processing ability (Plummer-D'Amato et al., 2008). The primary task will be the box and block test (BBT) assessed with a wooden box containing 2 equally sized compartments. Cubes will be placed in 1 compartment, and the participants will be instructed to use their paretic hand to transport the cubes to the other compartment 1-by-1 in their fastest speed. The number of cubes moved within 60 seconds will be recorded. While performing the BBT, the participants will be required to perform a secondary task - counting backward by 7 or responding as fast as possible to different tones.
Change scores of Medical Research Council scale (MRC)
Time frame: Baseline, 3 months, 6 months
The MRC is an ordinal scale that assesses muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates stronger muscle. The reliability of MRC for all muscle groups was good to excellent in patients with stroke (Gregson et al., 2000).
Change scores of Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 3 months, 6 months
It is a 30-point test, which evaluates different domains: visuospatial abilities, executive functions, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space (Nasreddine et al., 2005). The MoCA has been recommended as a valid and reliable clinical assessment in patients with stroke (Wong et al., 2013).
Change scores of Wolf Motor Function Test (WMFT)
Time frame: Baseline, 3 months, 6 months
The WMFT was developed by Wolf and colleagues to quantitatively assess UE motor ability via 15 function-based tasks and 2 strength-based tasks. The WMFT-time measures the time required to complete the tasks, and the WMFT-quality assesses functional ability on a 6-point ordinal scale. A lower WMFT-time performance indicates faster movement, whereas a higher WMFT-quality score suggests better quality of movement (Wolf, Lecraw, Barton, \& Jann, 1989). The reliability of the WMFT is excellent (Wolf et al., 2001).
Change scores of Motor Activity Log (MAL)
Time frame: Baseline, 3 months, 6 months
The MAL is a semi-structured interview to evaluate the amount of use (AOU) and quality of movement (QOM) of the paretic UE for patients with stroke. The MAL involves 30 functional tasks of daily living, including object manipulation and gross motor activities. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality (Taub et al., 1993). The responsiveness, validity, and reliability have been investigated in patients with stroke (Van der Lee, Beckerman, Knol, De Vet, \& Bouter, 2004).
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Baseline, 3 months, 6 months
The NEADL is a self-report scale that measures instrumental activities of daily living. It evaluates 4 areas of daily living, including mobility, kitchen, domestic, and leisure activities. The total score is 0 to 66, and a higher score indicates better daily functional ability. The psychometric properties of NEADL have been well established (Green \& Young, 2001; Wu, Chuang, Lin, \& Hong, 2011).
Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: Baseline, 3 months, 6 months
Health-related quality of life will be evaluated with the SIS 3.0. The SIS consists of 59 test items grouped into 8 domains (strength, hand function, ADL/instrumental ADL, mobility, communication, emotion, memory and thinking, and participation/role function). The participants will be asked to rate each item in a 5-point Likert scale regarding the perceived difficulty in completing the task. The total score for each domain ranges from 0 to 100. An extra question will be asked to evaluate the participant's self-perceived overall recovery from stroke. The SIS 3.0 has satisfactory psychometric properties (Duncan, Bode, Lai, Perera, \& Investigators, 2003; Vellone et al., 2015).
Change scores of Functional Abilities Confidence Scale (FACS)
Time frame: Baseline, 3 months, 6 months
It measures the degree of self-efficacy and confidence when the participants do various movements and postures. It concludes 15 questions which scores from 0% (not confidence at all) to 100% (fully confidence). The higher percentage means the higher confidence of doing the movements. The clinimetric properties are good (Williams \& Myers, 1998).
Change scores of Stroke Self-Efficacy Questionnaire (SSEQ)
Time frame: Baseline, 3 months, 6 months
It measures the self-efficacy judgements in specific domains in relation to functional performance and self-management for stroke. It includes 13 items, which rates on a 10-point scale from 0 (not at all confident) to 10 (very confident). In addition, its psychometric testing is a valid measurement for stroke (Jones, Partridge, \& Reid, 2008).
Change scores of Daily Living Self-Efficacy Scale (DLSES)
Time frame: Baseline, 3 months, 6 months
DLSES measures the self-efficacy in daily functions which contains 2 subscales (psychosocial functioning and activities of daily living). It has 12 items, with 10-unit intervals from 0 to 100 (0 = cannot do at all, 100 = highly certain can do). The total score is to sum up the scores of 12 items and is divided by 12. The higher score means higher self-efficacy and the psychometric properties are good (Maujean, Davis, Kendall, Casey, \& Loxton, 2014).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation, tDCS, functional electrical stimulation, FES and no stimulation in people with Cerebrovascular Accident, run by Chang Gung Memorial Hospital at 1 site 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-yi Wu, ScD (#886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Fugl-Meyer Assessment (FMA) (time frame: Baseline, 3 months, 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2021.