StrokeNCT04326140
Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke
A study testing mirror therapy and robotic-assisted training in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- mirror therapy and robotic-assisted training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2019to Dec 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stroke more than 3 months.
- Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
- The myoelectric signal can be detected to activate the instrument
- Unilateral paresis (FMA score<60)
- No serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
- Can provide informed consent
Who cannot join
- Other neurological disease
- Complete sense of body defect
- Inability to understand instructions
- current participation in any other research
- Botulinum Toxin injection within 3 months
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
Ching-Yi Wu, ScD
About this study
Official title: Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke: Randomized Clinical Trial and Neuromuscular Mechanism
This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke.
Read the detailed description
Approximately 70% to 80 % of stroke patients suffered from upper limb (UE) hemiparesis which limited their daily function and quality of life, as well as required considerable demands of long-term medical care. Robot-assisted training and mirror priming has been advocated as part of contemporary approaches. The robotic-assisted therapy mainly emphasized on the proximal part of UE, such as shoulder and elbow movement. While mirror priming strategy has been increasingly employed in the UE training, one question has been raised: the affected UE of stroke patients cannot complete the same movement as the sounded limb synchronously. This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke. This project will further explore the possible neuro-muscular mechanism underlying this combined mirror priming with robotic training. This project attempts to compare the cortical activation and neuromuscular control of patients with stroke and age-matched healthy adults in terms of electroencephalography (EEG) and muscle tone measurement. The findings of this study may lay an evidence-based foundation for bridging basic science and clinical application.
- Conditions
- Stroke
- Being tested
- mirror therapy, robotic-assisted training, sham mirror therapy
- Keywords
- Robot assisted therapy, mirror priming, upper limb, neuromuscular mechanism
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyDevice
The affected side wears the machine, assists by the machine, and performs the same action with the good hand. According to the posture condition, selects two suitable actions in the three actions (all fingers open, all fingers close, all fingers open and close). The action is 10 minutes each.
robotic-assisted trainingDevice
The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.
sham mirror therapyDevice
The mirror was masked. The intervention was the same as the mirror therapy.
| Study group | Role | What they receive |
|---|---|---|
| Robotic training with mirror therapy | Experimental | Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode). Receives: Device: mirror therapy; Device: robotic-assisted training |
| Robotic-assisted training | Sham comparator | The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session. Receives: Device: robotic-assisted training; Device: sham mirror therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Fugl-Myer Assessment (FMA)
The upper-extremity subscale of the FMA will be used to assess motor impairment. There are 33 upper extremity items measuring the movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. Each score is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The maximum score is 66, indicating optimal recovery. The subscore of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to investigate the treatment effects on separate upper extremity elements. The FMA has good reliability, validity, and responsiveness in stroke patients.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Active Range of Motion (AROM)
Patient performs the exercise to move the joint without any assistance to the muscles surrounding the joint.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of grip and pinch power
The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. Excellent concurrent validity of the Jamar hand dynamometer is reported. The Jamar hand dynamometer measure the grip-strength. The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb. Higher value represent a greater grip-strength.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Modified Ashworth Scale (MAS)
The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Higher score indicates higher muscle tone. 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 were established to be adequate to good.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Wolf Motor Function Test (WMFT)
The WMFT was designed to assess the effects of CIT on arm function after stroke and traumatic brain injury (Wolf, Lecraw, Barton, \& Jann, 1989). There are 15 function-based and 2 strength-based tasks. For timed functional tasks, completion times from 0 to 120 seconds are averaged. For functional ability scoring, 6-point ordinal scales are used, 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.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of 10-Meter Walk Test (10MWT)
We include this test because improvement in UL motor control may contribute to arm swing and help generate forward propulsion at the foot (Tester, Barbeau, Howland, Cantrell, \& Behrman, 2012) and may improve mobility and functional ambulation (Lin, et al., 2009). 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 (Rossier \& Wade, 2001). The velocity and stride length of the participant are calculated. Research has validated the 10MWT in measuring mobility in stroke.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Electromyography (EMG)
Raw EMG activities from the muscles of interest during unilateral and bilateral reaching while the patient is sitting and standing will be recorded using the AcqKnowledge data analysis software.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Mini-Mental State Exam (MMSE)
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitvie functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
The NEADL scale is a measure of Instrumental ADL ability, comprising sub-scales for mobility, household ability and leisure activity. The NEADL consists of 22 activity items, scoring on the basis of the required level of assistance. The range of total score is 0-66, and higher score representing better function. This measure is administered 3 times during the study period.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Stroke Impact Scale (SIS)
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, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of stroke self-efficacy questionnaire (SSEQ)
the Stroke Self-Efficacy Questionnaire (SSEQ) , a questionnaire developed to measure the most relevant self-efficacy and self-management domains specific to the stroke population. It contains 13 items that are rated on a 0 - 10 scale, with higher scores indicating greater levels of self-efficacy. Questionnaire includes a range of relevant functional tasks such as walking, getting comfortable in bed, as well as some self-management tasks.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Daily Living Self-Efficacy Scale (DLSES)
The DLSES is designed to measure self-efficacy in psychosocial functioning and self-efficacy in activities of daily living, regardless of level of physical impairment.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Change scores of Functional Abilities Confidence Scale (FACS)
The Functional Abilities Confidence Scale (FACS) was designed to measure the degree of self-efficacy or confidence a patient exhibits with various movements or postures.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Task-based Electroencephalogram (EEG)
The Task-based EEG will be collected when participants perform the n-back task before and after the intervention program to examine the effects of training on neural plasticity.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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 start1 Dec 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 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
- NCT04326140
- Sponsor's protocol ID
- 201801525B0
- Status last verified
- May 2021
- First submitted
- 26 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
- Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke: Randomized Clinical Trial and Neuromuscular Mechanism
- ClinicalTrials.gov ID
- NCT04326140
- Acronym / sponsor ID
- 201801525B0
- Conditions
- Stroke
- Keywords
- Robot assisted therapy, mirror priming, upper limb, neuromuscular mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (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.
This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke.
Detailed description
Approximately 70% to 80 % of stroke patients suffered from upper limb (UE) hemiparesis which limited their daily function and quality of life, as well as required considerable demands of long-term medical care. Robot-assisted training and mirror priming has been advocated as part of contemporary approaches. The robotic-assisted therapy mainly emphasized on the proximal part of UE, such as shoulder and elbow movement. While mirror priming strategy has been increasingly employed in the UE training, one question has been raised: the affected UE of stroke patients cannot complete the same movement as the sounded limb synchronously. This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke. This project will further explore the possible neuro-muscular mechanism underlying this combined mirror priming with robotic training. This project attempts to compare the cortical activation and neuromuscular control of patients with stroke and age-matched healthy adults in terms of electroencephalography (EEG) and muscle tone measurement. The findings of this study may lay an evidence-based foundation for bridging basic science and clinical application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic training with mirror therapy | Experimental | Device: mirror therapy, Device: robotic-assisted trainingParticipants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode). |
| Robotic-assisted training | Sham comparator | Device: robotic-assisted training, Device: sham mirror therapyThe training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stroke more than 3 months.
- Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
- The myoelectric signal can be detected to activate the instrument
- Unilateral paresis (FMA score<60)
- No serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
Key exclusion criteria (5 listed)
- Other neurological disease
- Complete sense of body defect
- Inability to understand instructions
- current participation in any other research
- Botulinum Toxin injection within 3 months
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 therapyThe affected side wears the machine, assists by the machine, and performs the same action with the good hand. According to the posture condition, selects two suitable actions in the three actions (all fingers open, all fingers close, all fingers open and close). The action is 10 minutes each. | Device | Robotic training with mirror therapy |
| robotic-assisted trainingThe hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need. | Device | Robotic training with mirror therapy, Robotic-assisted training |
| sham mirror therapyThe mirror was masked. The intervention was the same as the mirror therapy. | Device | Robotic-assisted training |
Primary outcome
Change scores of Fugl-Myer Assessment (FMA)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The upper-extremity subscale of the FMA will be used to assess motor impairment. There are 33 upper extremity items measuring the movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. Each score is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The maximum score is 66, indicating optimal recovery. The subscore of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to investigate the treatment effects on separate upper extremity elements. The FMA has good reliability, validity, and responsiveness in stroke patients.
Change scores of Active Range of Motion (AROM)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Patient performs the exercise to move the joint without any assistance to the muscles surrounding the joint.
Change scores of grip and pinch power
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. Excellent concurrent validity of the Jamar hand dynamometer is reported. The Jamar hand dynamometer measure the grip-strength. The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb. Higher value represent a greater grip-strength.
Change scores of Modified Ashworth Scale (MAS)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Higher score indicates higher muscle tone. 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 were established to be adequate to good.
Change scores of Medical Research Council scale (MRC)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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.
Change scores of Revised Nottingham Sensory Assessment (rNSA)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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).
Change scores of Wolf Motor Function Test (WMFT)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The WMFT was designed to assess the effects of CIT on arm function after stroke and traumatic brain injury (Wolf, Lecraw, Barton, \& Jann, 1989). There are 15 function-based and 2 strength-based tasks. For timed functional tasks, completion times from 0 to 120 seconds are averaged. For functional ability scoring, 6-point ordinal scales are used, 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.
Change scores of 10-Meter Walk Test (10MWT)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
We include this test because improvement in UL motor control may contribute to arm swing and help generate forward propulsion at the foot (Tester, Barbeau, Howland, Cantrell, \& Behrman, 2012) and may improve mobility and functional ambulation (Lin, et al., 2009). 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 (Rossier \& Wade, 2001). The velocity and stride length of the participant are calculated. Research has validated the 10MWT in measuring mobility in stroke.
Electromyography (EMG)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Raw EMG activities from the muscles of interest during unilateral and bilateral reaching while the patient is sitting and standing will be recorded using the AcqKnowledge data analysis software.
Change scores of Mini-Mental State Exam (MMSE)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.
Change scores of Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitvie functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
Change scores of Motor Activity Log (MAL)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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 Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The NEADL scale is a measure of Instrumental ADL ability, comprising sub-scales for mobility, household ability and leisure activity. The NEADL consists of 22 activity items, scoring on the basis of the required level of assistance. The range of total score is 0-66, and higher score representing better function. This measure is administered 3 times during the study period.
Change scores of Stroke Impact Scale (SIS)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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 stroke self-efficacy questionnaire (SSEQ)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
the Stroke Self-Efficacy Questionnaire (SSEQ) , a questionnaire developed to measure the most relevant self-efficacy and self-management domains specific to the stroke population. It contains 13 items that are rated on a 0 - 10 scale, with higher scores indicating greater levels of self-efficacy. Questionnaire includes a range of relevant functional tasks such as walking, getting comfortable in bed, as well as some self-management tasks.
Change scores of Daily Living Self-Efficacy Scale (DLSES)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The DLSES is designed to measure self-efficacy in psychosocial functioning and self-efficacy in activities of daily living, regardless of level of physical impairment.
Change scores of Functional Abilities Confidence Scale (FACS)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Functional Abilities Confidence Scale (FACS) was designed to measure the degree of self-efficacy or confidence a patient exhibits with various movements or postures.
Kinematic analysis
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
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.
Task-based Electroencephalogram (EEG)
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
The Task-based EEG will be collected when participants perform the n-back task before and after the intervention program to examine the effects of training on neural plasticity.
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 mirror therapy and robotic-assisted training in people with Stroke, 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 6 inclusion and 5 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-Myer Assessment (FMA) (time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)). The study lists 19 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.