Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke
Study Details
Study Description
Brief Summary
This is a single-blind randomized comparative efficacy study involving 40 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 40 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRI group 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 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.
Other Names:
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| Active Comparator: DRI group 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Fugl-Meyer Assessment [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 [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 [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 [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 [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 [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.
- The Revised Nottingham Sensory Assessment [The Revised Nottingham Sensory Assessment will be administered to participants at baseline.]
The Revised Nottingham Sensory Assessment is used to assess sensory impairment, including pressure, temperature, light touch, kinesthetic sense on the shoulder, elbow, wrist, and hand, and stereognosis.
- The Revised Nottingham Sensory Assessment [The Revised Nottingham Sensory Assessment will be administered to participants immediately after intervention.]
The Revised Nottingham Sensory Assessment is used to assess sensory impairment, including pressure, temperature, light touch, kinesthetic sense on the shoulder, elbow, wrist, and hand, and stereognosis.
- The Revised Nottingham Sensory Assessment [The Revised Nottingham Sensory Assessment will be administered to participants three months after intervention.]
The Revised Nottingham Sensory Assessment is used to assess sensory impairment, including pressure, temperature, light touch, kinesthetic sense on the shoulder, elbow, wrist, and hand, and stereognosis.
- The Wolf Motor Function Test [The Wolf Motor Function Test will be administered to participants at baseline.]
The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
- The Wolf Motor Function Test [The Wolf Motor Function Test will be administered to participants immediately after intervention.]
The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
- The Wolf Motor Function Test [The Wolf Motor Function Test will be administered to participants three months after intervention.]
The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
Secondary Outcome Measures
- The 10-Meter Walk Test [The 10-Meter Walk Test will be administered to participants at baseline.]
The 10-Meter Walk Test is used to assess walking speed.
- The 10-Meter Walk Test [The 10-Meter Walk Test will be administered to participants immediately after intervention.]
The 10-Meter Walk Test is used to assess walking speed.
- The 10-Meter Walk Test [The 10-Meter Walk Test will be administered to participants three months after intervention.]
The 10-Meter Walk Test is used to assess walking speed.
- The MyotonPRO Digital Palpation Device (MyotonPRO) [The MyotonPro will be administered to participants at baseline.]
The MyotonPro is a handheld device that is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties (stiffness, elasticity and tone) of patients positioned supine.
- The MyotonPro [The MyotonPro will be administered to participants immediately after intervention.]
The MyotonPro is a handheld device that is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties (stiffness, elasticity and tone) of patients positioned supine.
- The MyotonPro [The MyotonPro will be administered to participants three months after intervention.]
The MyotonPro is a handheld device that is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties (stiffness, elasticity and tone) of patients positioned supine.
- The Actigraphy [The Actigraphy will be administered to participants at baseline.]
The Actigraphy is a device that is worn on the wrist and may record activity levels of the patient's upper extremity.
- The Actigraphy [The Actigraphy will be administered to participants immediately after intervention.]
The Actigraphy is a device that is worn on the wrist and may record activity levels of the patient's upper extremity.
- The Actigraphy [The Actigraphy will be administered to participants three months after intervention.]
The Actigraphy is a device that is worn on the wrist and may record activity levels of the patient's upper extremity.
- The Functional Independence Measure Motor Scale [The Functional Independence Measure Motor Scale will be administered to participants at baseline]
The Functional Independence Measure Motor Scale is a 13-item instrument which evaluates an individual's disability related to motor aspect of care burden. Each item is scored on a 7-point scale according to the amount of assistance required to complete the task, from total assistance (score =1) to independence (score =7). The possible total score range for the Motor Scale is 13-91.
- The Functional Independence Measure Motor Scale [The Functional Independence Measure Motor Scale will be administered to participants immediately after intervention.]
The Functional Independence Measure Motor Scale is a 13-item instrument which evaluates an individual's disability related to motor aspect of care burden. Each item is scored on a 7-point scale according to the amount of assistance required to complete the task, from total assistance (score =1) to independence (score =7). The possible total score range for the Motor Scale is 13-91.
- The Functional Independence Measure Motor Scale [The Functional Independence Measure Motor Scale will be administered to participants three months after intervention.]
The Functional Independence Measure Motor Scale is a 13-item instrument which evaluates an individual's disability related to motor aspect of care burden. Each item is scored on a 7-point scale according to the amount of assistance required to complete the task, from total assistance (score =1) to independence (score =7). The possible total score range for the Motor Scale is 13-91.
- The Functional Independence Measure Cognitive Scale [The Functional Independence Measure Cognitive Scale will be administered to participants at baseline.]
The Functional Independence Measure Cognitive Scale is a 5-item instrument which evaluates an individual's disability related to cognitive aspect of care burden. Each item is scored on a 7-point scale according to the amount of assistance required to complete the task, from total assistance (score =1) to independence (score =7). The possible total score range for the Motor Scale is 5-35.
- The Functional Independence Measure Cognitive Scale [The Functional Independence Measure Cognitive Scale will be administered to participants immediately after intervention.]
The Functional Independence Measure Cognitive Scale is a 5-item instrument which evaluates an individual's disability related to cognitive aspect of care burden. Each item is scored on a 7-point scale according to the amount of assistance required to complete the task, from total assistance (score =1) to independence (score =7). The possible total score range for the Motor Scale is 5-35.
- The Functional Independence Measure Cognitive Scale [The Functional Independence Measure Cognitive Scale will be administered to participants 3 months after intervention.]
The Functional Independence Measure Cognitive Scale is a 5-item instrument which evaluates an individual's disability related to cognitive aspect of care burden. Each item is scored on a 7-point scale according to the amount of assistance required to complete the task, from total assistance (score =1) to independence (score =7). The possible total score range for the Motor Scale is 5-35.
- The Motor Activity Log [The Motor Activity Log will be administered to participants at baseline.]
The Motor Activity Log is a semi-structured interview of 30 items and is used to assess the amount of use of the affected upper extremity and the quality of the movement during functional daily activities.
- The Motor Activity Log [The Motor Activity Log will be administered to participants immediately after intervention.]
The Motor Activity Log is a semi-structured interview of 30 items and is used to assess the amount of use of the affected upper extremity and the quality of the movement during functional daily activities.
- The Motor Activity Log [The Motor Activity Log will be administered to participants three months after intervention.]
The Motor Activity Log is a semi-structured interview of 30 items and is used to assess the amount of use of the affected upper extremity and the quality of the movement during functional daily activities.
- The ABILHAND Questionnaire [The ABILHAND Questionnaire will be administered to participants at baseline.]
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).
- The ABILHAND Questionnaire [The ABILHAND Questionnaire will be administered to participants immediately after intervention..]
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).
- The ABILHAND Questionnaire [The ABILHAND Questionnaire will be administered to participants three months after intervention..]
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).
- The Nottingham Extended Activities of Daily Living Scale [The Nottingham Extended Activities of Daily Living Scale will be administered to participants at baseline.]
The Nottingham Extended Activities of Daily Living Scale is used to measure patient's independence in instrumental activities of daily living in the past few weeks across four domains: mobility, kitchen, domestic, and leisure activities. The scores range from 0 to 21 and higher scores represent greater independence.
- The Nottingham Extended Activities of Daily Living Scale [The Nottingham Extended Activities of Daily Living Scale will be administered to participants immediately after intervention.]
The Nottingham Extended Activities of Daily Living Scale is used to measure patient's independence in instrumental activities of daily living in the past few weeks across four domains: mobility, kitchen, domestic, and leisure activities. The scores range from 0 to 21 and higher scores represent greater independence.
- The Nottingham Extended Activities of Daily Living Scale [The Nottingham Extended Activities of Daily Living Scale will be administered to participants three months after intervention.]
The Nottingham Extended Activities of Daily Living Scale is used to measure patient's independence in instrumental activities of daily living in the past few weeks across four domains: mobility, kitchen, domestic, and leisure activities. The scores range from 0 to 21 and higher scores represent greater independence.
- The Stoke Impact Scale 3.0 [The Stoke Impact Scale 3.0 will be administered to participants at baseline.]
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.
- The Stoke Impact Scale 3.0 [The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.]
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.
- The Stoke Impact Scale 3.0 [The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.]
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.
- The Goal Attainment Scale [The Goal Attainment Scale will be administered to participants at baseline.]
The Goal Attainment Scale is an individualized outcome measure for goal setting in an intervention and goal scaling to estimate the extent to which the patient's goals are met. Five levels of attainment represented by scores ranging from --2 to +2 and a higher score represents better outcome.
- The Goal Attainment Scale [The Goal Attainment Scale will be administered to participants immediately after intervention.]
The Goal Attainment Scale is an individualized outcome measure for goal setting in an intervention and goal scaling to estimate the extent to which the patient's goals are met. Five levels of attainment represented by scores ranging from --2 to +2 and a higher score represents better outcome.
- The Goal Attainment Scale [The Goal Attainment Scale will be administered to participants three months after intervention.]
The Goal Attainment Scale is an individualized outcome measure for goal setting in an intervention and goal scaling to estimate the extent to which the patient's goals are met. Five levels of attainment represented by scores ranging from --2 to +2 and a higher score represents better outcome.
- The Stroke Self-Efficacy Questionnaire [The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.]
The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
- The Stroke Self-Efficacy Questionnaire [The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.]
The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
- The Stroke Self-Efficacy Questionnaire [The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.]
The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fongyuan Hospital | Taichung | Taiwan | ||
| 2 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
- National Health Research Institutes, Taiwan
- Ministry of Science and Technology, Taiwan
Investigators
- Principal Investigator: Keh-chung Lin, ScD, National Taiwan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202004105RINB