Back to resultsProximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bi-Manu-Track
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Upper extremity rehabilitation, Proximal priority, Distal priority, Robotic therapy, Bilateral motor priming, Impairment-oriented training, Task-oriented training
Eligibility 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.
Sites / Locations
- Fongyuan HospitalRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRI group
DRI group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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
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 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 is used to assess muscle power of the affected upper extremity joints.
Medical Research Council Scale
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Medical Research Council Scale
Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
Secondary Outcome Measures
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
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 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 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
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 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 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
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 is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
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
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 is used to assess functional motor ability of the upper extremity with 15 functional tasks.
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
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.
Full Information
NCT ID
NCT04446273
First Posted
June 18, 2020
Last Updated
October 16, 2023
Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan, Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT04446273
Brief Title
Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke
Official Title
Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Health Research Institutes, Taiwan, Ministry of Science and Technology, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Upper extremity rehabilitation, Proximal priority, Distal priority, Robotic therapy, Bilateral motor priming, Impairment-oriented training, Task-oriented training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Initial and outcome assessments will be administered by a well-trained and certified occupational therapist who is blinded to the group assignment, study hypotheses, and intervention of the patients.
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRI group
Arm Type
Experimental
Arm Description
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).
Arm Title
DRI group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Bi-Manu-Track
Other Intervention Name(s)
impairment-oriented training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
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.
Title
Fugl-Meyer Assessment
Description
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.
Title
Fugl-Meyer Assessment
Description
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.
Title
Medical Research Council Scale
Description
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.
Title
Medical Research Council Scale
Description
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.
Title
Medical Research Council Scale
Description
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.
Secondary Outcome Measure Information:
Title
The ABILHAND Questionnaire
Description
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.
Title
The ABILHAND Questionnaire
Description
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..
Title
The ABILHAND Questionnaire
Description
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..
Title
The Stoke Impact Scale 3.0
Description
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.
Title
The Stoke Impact Scale 3.0
Description
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.
Title
The Stoke Impact Scale 3.0
Description
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.
Title
The Stroke Self-Efficacy Questionnaire
Description
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.
Title
The Stroke Self-Efficacy Questionnaire
Description
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.
Title
The Stroke Self-Efficacy Questionnaire
Description
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.
Title
The Wolf Motor Function Test
Description
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.
Title
The Wolf Motor Function Test
Description
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.
Title
The Wolf Motor Function Test
Description
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.
Title
The Montreal Cognitive Assessment
Description
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.
Title
The Montreal Cognitive Assessment
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kehchung Lin, ScD
Phone
+886233668180
Email
kehchunglin@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, ScD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fongyuan Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, ScD
Phone
886 233668180
Email
kehchunglin@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34496938
Citation
Lee 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.
Results Reference
derived
Learn more about this trial
Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke
We'll reach out to this number within 24 hrs