StrokeNCT04446273
Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke
A study testing Bi-Manu-Track in people with Stroke, run by National Taiwan University Hospital at 4 sites in Taiwan.
Trial summary
This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). 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?
- Bi-Manu-Track
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 4 sitesTaiwan
- Study dates
- 3 Jul 2020to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment [FMA] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score <3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score >24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies.
Who cannot join
- The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan4 sites, 4 recruiting
- Recruiting
Taipei Tzu Chi Hospital
New Taipei City
Wan-Ling Hsu, MS, mysalvia@gmail.com
- Recruiting
Fongyuan Hospital
Taichung
Chih-Chieh Kuo, MS, snowwinglightsea@hotmail.com
- Recruiting
National Taiwan University Hospital
Taipei, Taipei, 100
Keh-chung Lin, ScD, 886 233668180, kehchunglin@ntu.edu.tw
- Recruiting
Taipei Municipal Wan Fang Hospital
Taipei, 116
Han-Ting Tsai, MS, 97463@w.tmu.edu.tw
About this study
Official title: Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke
This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.
Read the detailed description
Background. The sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).
Methods. This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.
- Conditions
- Stroke
- Being tested
- Bi-Manu-Track
- Keywords
- Upper extremity rehabilitation, Proximal priority, Distal priority, Robotic therapy, Bilateral motor priming, Impairment-oriented training, Task-oriented training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-Manu-TrackDevice
Also called impairment-oriented training
The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.
| Study group | Role | What they receive |
|---|---|---|
| PRI group | Experimental | The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The PRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). Receives: Device: Bi-Manu-Track |
| DRI group | Active comparator | The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The DRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm). Receives: Device: Bi-Manu-Track |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the upper extremity (UE) joints, and grasping, coordination, and speed of UE. movement.
Measured: Fugl-Meyer Assessment will be administered to participants at baseline.
Fugl-Meyer Assessment
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE movement.
Measured: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.
Fugl-Meyer Assessment
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE. movement.
Measured: Fugl-Meyer Assessment will be administered to participants at three months after intervention.
Medical Research Council Scale
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Measured: Medical Research Council Scale will be administered to participants at baseline.
Medical Research Council Scale
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Measured: Medical Research Council Scale will be administered to participants immediately after intervention.
Medical Research Council Scale
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Measured: Medical Research Council Scale will be administered to participants three months after intervention.
Secondary outcomes (17)
The ABILHAND Questionnaire
The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).
Measured: The ABILHAND Questionnaire will be administered to participants at baseline.
The ABILHAND Questionnaire
The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).
Measured: The ABILHAND Questionnaire will be administered to participants immediately after intervention..
The ABILHAND Questionnaire
The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).
Measured: The ABILHAND Questionnaire will be administered to participants three months after intervention..
The Stoke Impact Scale 3.0
The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.
Measured: The Stoke Impact Scale 3.0 will be administered to participants at baseline.
The Stoke Impact Scale 3.0
The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.
Measured: The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.
The Stoke Impact Scale 3.0
The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.
Measured: The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.
The Stroke Self-Efficacy Questionnaire
The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
Measured: The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.
The Stroke Self-Efficacy Questionnaire
The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
Measured: The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.
The Stroke Self-Efficacy Questionnaire
The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
Measured: The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.
The Wolf Motor Function Test
The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
Measured: The Wolf Motor Function Test will be administered to participants at baseline.
The Wolf Motor Function Test
The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
Measured: The Wolf Motor Function Test will be administered to participants immediately after intervention.
The Wolf Motor Function Test
The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
Measured: The Wolf Motor Function Test will be administered to participants three months after intervention.
The Montreal Cognitive Assessment
The Montreal Cognitive Assessment is a cognitive screening assessment that is used to measure several cognitive domains, which include working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place. The total score ranges from 0 to 30. One extra point is added to adjust the total score for participants who received less than 12 years of education.
Measured: The Montreal Cognitive Assessment will be administered to participants at baseline.
The Montreal Cognitive Assessment
The Montreal Cognitive Assessment is a cognitive screening assessment that is used to measure several cognitive domains, which include working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place. The total score ranges from 0 to 30. One extra point is added to adjust the total score for participants who received less than 12 years of education.
Measured: The Montreal Cognitive Assessment will be administered to participants immediately after intervention.
The Chedoke Arm and Hand Activity Inventory
The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.
Measured: The Chedoke Arm and Hand Activity Inventory will be administered to participants at baseline.
The Chedoke Arm and Hand Activity Inventory
The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.
Measured: The Chedoke Arm and Hand Activity Inventory will be administered to participants immediately after intervention.
The Chedoke Arm and Hand Activity Inventory
The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.
Measured: The Chedoke Arm and Hand Activity Inventory will be administered to participants three months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start3 Jul 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Model description
- Participants will be randomized into the proximal priority robotic priming and impairment-oriented training or the distal priority robotic priming and impairment-oriented training groups and receive 18 intervention sessions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Keh-chung Lin, ScD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446273
- Sponsor's protocol ID
- 202004105RINB
- Status last verified
- Feb 2026
- First submitted
- 18 Jun 2020
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3.
PubMed 38433459Lee YC, Li YC, Lin KC, Chen CL, Wu YH, Kuo C, Yeh YP, Liu TX. Effects of proximal priority and distal priority robotic priming techniques with impairment-oriented training of upper limb functions in patients with chronic stroke: study protocol for a single-blind, randomized controlled trial. Trials. 2021 Sep 8;22(1):604. doi: 10.1186/s13063-021-05561-6.
PubMed 34496938
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04446273
- Acronym / sponsor ID
- 202004105RINB
- Conditions
- Stroke
- Keywords
- Upper extremity rehabilitation, Proximal priority, Distal priority, Robotic therapy, Bilateral motor priming, Impairment-oriented training, Task-oriented training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Ministry of Science and Technology, Taiwan
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Jun 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 is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.
Detailed description
Background. The sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).
Methods. This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into the proximal priority robotic priming and impairment-oriented training or the distal priority robotic priming and impairment-oriented training groups and receive 18 intervention sessions
| Arm | Type | Receives |
|---|---|---|
| PRI group | Experimental | Device: Bi-Manu-TrackThe PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The PRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). |
| DRI group | Active comparator | Device: Bi-Manu-TrackThe PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The DRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment [FMA] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score <3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score >24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies.
Key exclusion criteria (1 listed)
- The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.
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 |
|---|---|---|
| Bi-Manu-TrackAlso: impairment-oriented trainingThe PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training. | Device | DRI group, PRI group |
Primary outcome
Fugl-Meyer Assessment
Time frame: Fugl-Meyer Assessment will be administered to participants at baseline.
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the upper extremity (UE) joints, and grasping, coordination, and speed of UE. movement.
Fugl-Meyer Assessment
Time frame: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE movement.
Fugl-Meyer Assessment
Time frame: Fugl-Meyer Assessment will be administered to participants at three months after intervention.
Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE. movement.
Medical Research Council Scale
Time frame: Medical Research Council Scale will be administered to participants at baseline.
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Medical Research Council Scale
Time frame: Medical Research Council Scale will be administered to participants immediately after intervention.
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Medical Research Council Scale
Time frame: Medical Research Council Scale will be administered to participants three months after intervention.
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
17 secondary outcomes
The ABILHAND Questionnaire
Time frame: The ABILHAND Questionnaire will be administered to participants at baseline.
The ABILHAND Questionnaire
Time frame: The ABILHAND Questionnaire will be administered to participants immediately after intervention..
The ABILHAND Questionnaire
Time frame: The ABILHAND Questionnaire will be administered to participants three months after intervention..
The Stoke Impact Scale 3.0
Time frame: The Stoke Impact Scale 3.0 will be administered to participants at baseline.
The Stoke Impact Scale 3.0
Time frame: The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.
The Stoke Impact Scale 3.0
Time frame: The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.
The Stroke Self-Efficacy Questionnaire
Time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.
The Stroke Self-Efficacy Questionnaire
Time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.
The Stroke Self-Efficacy Questionnaire
Time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.
The Wolf Motor Function Test
Time frame: The Wolf Motor Function Test will be administered to participants at baseline.
The Wolf Motor Function Test
Time frame: The Wolf Motor Function Test will be administered to participants immediately after intervention.
The Wolf Motor Function Test
Time frame: The Wolf Motor Function Test will be administered to participants three months after intervention.
The Montreal Cognitive Assessment
Time frame: The Montreal Cognitive Assessment will be administered to participants at baseline.
The Montreal Cognitive Assessment
Time frame: The Montreal Cognitive Assessment will be administered to participants immediately after intervention.
The Chedoke Arm and Hand Activity Inventory
Time frame: The Chedoke Arm and Hand Activity Inventory will be administered to participants at baseline.
The Chedoke Arm and Hand Activity Inventory
Time frame: The Chedoke Arm and Hand Activity Inventory will be administered to participants immediately after intervention.
The Chedoke Arm and Hand Activity Inventory
Time frame: The Chedoke Arm and Hand Activity Inventory will be administered to participants three months after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 38433459Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3.
- Derived from this study: PubMed 34496938Lee YC, Li YC, Lin KC, Chen CL, Wu YH, Kuo C, Yeh YP, Liu TX. Effects of proximal priority and distal priority robotic priming techniques with impairment-oriented training of upper limb functions in patients with chronic stroke: study protocol for a single-blind, randomized controlled trial. Trials. 2021 Sep 8;22(1):604. doi: 10.1186/s13063-021-05561-6.
- Individual participant dataSharing planned: No
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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.
Keh-chung Lin, ScD principal investigator
National Taiwan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-Manu-Track in people with Stroke, run by National Taiwan University Hospital at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kehchung Lin, ScD (+886233668180, kehchunglin@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (time frame: Fugl-Meyer Assessment will be administered to participants at baseline.). The study lists 6 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 NCT04446273, which also lists 2 linked publications.
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 25 Feb 2026.