Chronic StrokeNCT03917511
Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients
A study testing Robotic training with mirror therapy and Robotic-assisted training in people with Chronic Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Robotic training with mirror therapy and Robotic-assisted training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Dec 2018to 20 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brain injury 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.
About this study
Official title: Effects of Combined Robot-assisted Therapy With Mirror Priming on Hand Function and Health-related Conditions in Patients With Stroke.
The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.
Read the detailed description
Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training.
This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.
- Conditions
- Chronic Stroke
- Being tested
- Robotic training with mirror therapy, Robotic-assisted training
- Keywords
- Stroke, Mirror therapy, Robotic Training, Neurorehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic training with mirror therapyBehavioural
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).
Robotic-assisted trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic training with mirror therapy | Experimental | 20 minutes mirror therapy followed by 40 minutes robotic-assisted training Receives: Behavioral: Robotic training with mirror therapy |
| Robotic-assisted training | Sham comparator | 20 minutes sham mirror therapy followed by 40 minutes robotic-assisted training Receives: Behavioral: Robotic-assisted training |
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 UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.
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(Jamar hand dynamometer)
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 MyotonPro
Investigators will use the MyotonPRO device to evaluate the viscoelastic properties of UE muscles.
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 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, 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)
Changes in sensation before and after intervention will be measured with rNSA. Tactile sensation,proprioception, and stereognosis will be assessed with various sensory modalities. The rNSA is scored based on a 3-point ordinal scale (0-2) with a higher score indicates better sensation. The psychometric properties of rNSA have been established 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 Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test evaluates upper extremity motor function via 15 function-based tasks and 2 strength-based tasks. The Wolf Motor Function Test -time evaluates the time required to complete the function-based tasks, and the Wolf Motor Function Test -quality assesses functional ability on a 6-point ordinal scale. A lower Wolf Motor Function Test -time performance indicates faster movement, whereas a higher Wolf Motor Function Test -quality score suggests better quality of movement. The psychometric properties of Wolf Motor Function Test have been established 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 Jamar hand dynamometer
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 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 Motor Activity Log (MAL)
The Motor Activity Log evaluates the amount of use (AOU) and quality of movement (QOM) of the affected hand in completing 30 common daily tasks. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality. The responsiveness, validity, and reliability have been established 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 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 0-66, and a higher score indicates better daily functional ability. The psychometric properties of NEADL have been well established.
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 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.
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)
Secondary outcomes (1)
Kinematic Analysis
The movements of the arm and trunk will be captured by a 7-camera motion analysis system during unilateral and bilateral reaching tasks. Kinematic variables, such as reaction time, movement time, peak velocity, path length during the tasks can assess a patient's motor function in daily activities after intervention.
Measured: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start17 Dec 2018
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
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 Chronic StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917511
- Sponsor's protocol ID
- 201801025B0
- Status last verified
- Jun 2021
- First submitted
- 8 Jan 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen YW, Li KY, Lin CH, Hung PH, Lai HT, Wu CY. The effect of sequential combination of mirror therapy and robot-assisted therapy on motor function, daily function, and self-efficacy after stroke. Sci Rep. 2023 Oct 6;13(1):16841. doi: 10.1038/s41598-023-43981-3.
PubMed 37803096
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Robot-assisted Therapy With Mirror Priming on Hand Function and Health-related Conditions in Patients With Stroke.
- ClinicalTrials.gov ID
- NCT03917511
- Acronym / sponsor ID
- 201801025B0
- Conditions
- Chronic Stroke
- Keywords
- Stroke, Mirror therapy, Robotic Training, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 17 Apr 2019 (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.
The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.
Detailed description
Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training.
This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic training with mirror therapy | Experimental | Behavioral: Robotic training with mirror therapy20 minutes mirror therapy followed by 40 minutes robotic-assisted training |
| Robotic-assisted training | Sham comparator | Behavioral: Robotic-assisted training20 minutes sham mirror therapy followed by 40 minutes robotic-assisted training |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Brain injury 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 |
|---|---|---|
| Robotic training with mirror therapyParticipants 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). | Behavioural | Robotic training with mirror therapy |
| Robotic-assisted trainingThe 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. | Behavioural | 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 UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.
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(Jamar hand dynamometer)
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 MyotonPro
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)
Investigators will use the MyotonPRO device to evaluate the viscoelastic properties of UE muscles.
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 pressure pain threshold
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 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.
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)
Changes in sensation before and after intervention will be measured with rNSA. Tactile sensation,proprioception, and stereognosis will be assessed with various sensory modalities. The rNSA is scored based on a 3-point ordinal scale (0-2) with a higher score indicates better sensation. The psychometric properties of rNSA have been established in patients with stroke.
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 Wolf Motor Function Test evaluates upper extremity motor function via 15 function-based tasks and 2 strength-based tasks. The Wolf Motor Function Test -time evaluates the time required to complete the function-based tasks, and the Wolf Motor Function Test -quality assesses functional ability on a 6-point ordinal scale. A lower Wolf Motor Function Test -time performance indicates faster movement, whereas a higher Wolf Motor Function Test -quality score suggests better quality of movement. The psychometric properties of Wolf Motor Function Test have been established in stroke patients.
Change scores of Jamar hand dynamometer
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 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 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 Motor Activity Log evaluates the amount of use (AOU) and quality of movement (QOM) of the affected hand in completing 30 common daily tasks. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality. The responsiveness, validity, and reliability have been established in stroke patients.
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 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 0-66, and a higher score indicates better daily functional ability. The psychometric properties of NEADL have been well established.
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 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.
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.
1 secondary outcome
Kinematic Analysis
Time frame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline)
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 2 Mar 2022.
- Derived from this study: PubMed 37803096Chen YW, Li KY, Lin CH, Hung PH, Lai HT, Wu CY. The effect of sequential combination of mirror therapy and robot-assisted therapy on motor function, daily function, and self-efficacy after stroke. Sci Rep. 2023 Oct 6;13(1):16841. doi: 10.1038/s41598-023-43981-3.
Related trials for Chronic Stroke
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Recruiting
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
Stroke, Ischemic, Chronic Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Not yet recruiting
Proof-of-concept for Use of Transcutaneous Spinal Stimulation (TSS) With the ExaStim® Stimulation System in Adults With Chronic Ischemic Stroke
Chronic Stroke, Ischemic Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
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 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic training with mirror therapy and Robotic-assisted training in people with Chronic 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: finished, as of the sponsor's last update on 2 Mar 2022. 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?
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-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 17 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 NCT03917511, 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 2 Mar 2022.