An interventional study of Bi-Manu-Track in Stroke, sponsored by National Taiwan University Hospital. Recruiting at 4 sites in Taiwan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 72 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
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).
Device: Bi-Manu-Track
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).
Device: Bi-Manu-Track
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.
Also known as: impairment-oriented training
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Medical Research Council Scale will be administered to participants three months 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The Chedoke Arm and Hand Activity Inventory will be administered to participants three months after intervention.
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