Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Bi-Manu-Track


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRI group<br>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<br>* 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.<br>* Other names: impairment-oriented training;|
| Active Comparator: DRI group<br>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<br>* 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.<br>* Other names: impairment-oriented training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Medical Research Council Scale will be administered to participants three months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | The Montreal Cognitive Assessment will be administered to participants immediately after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proximal priority, Upper extremity rehabilitation, Distal priority, Robotic therapy, Bilateral motor priming, Impairment-oriented training, Task-oriented training