Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
NCT ID: NCT05492175
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2022-02-17
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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proximal-prioritized robotic practice plus kinetic exergaming group
60 minutes per day, 3 days per week for 6 weeks
robotic practice
According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.
kinetic exergaming
All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed.
distal-prioritized robotic practice plus kinetic exergaming group
60 minutes per day, 3 days per week for 6 weeks
robotic practice
According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.
kinetic exergaming
All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed.
robotic practice plus conventional therapy group
60 minutes per day, 3 days per week for 6 weeks
robotic practice
According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.
conventional therapy
Participants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The content of the functional tasks will be decided together by participants and therapists, such as picking up and putting down items in a box, lifting two soft drink bottles, and so on.
Interventions
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robotic practice
According to the group assignment, participants will start from the BMT proximal mode (i.e., forearm pronation-supination movement), and then the distal mode (i.e., wrist flexion-extension movement), and vice versa. Each participant is expected to complete approximately 400 to 600 repetitions of the proximal mode session (i.e., forearm movements) and another 400 to 600 repetitions of the distal mode session (i.e., wrist movements), respectively.
kinetic exergaming
All of the participants in experimental and comparison groups will practice on the exergaming for 30 minutes per session. To avoid fatigue, the four domains of programs will be provided alternately. Each program will be executed for approximately 5 minutes with warm-up, followed by a 2-minute break between programs, and cool-down. The games will be selected and adapted according to the personal capacity, the occupational role, and the rehabilitation goal of each participant. The investigators will illustrate and guide the participants to play the games and stand next to them to prevent falls from occurring. To increase security, we will place a handrail in front of the participant for support as needed.
conventional therapy
Participants in control group will receive 30 minutes of therapist-mediated conventional therapy per session. The training protocols of the conventional therapy will use occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their personal needs. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The content of the functional tasks will be decided together by participants and therapists, such as picking up and putting down items in a box, lifting two soft drink bottles, and so on.
Eligibility Criteria
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Inclusion Criteria
2. age range between 20 to 80 years
3. baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
4. no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale \< 3 at any joints)
5. able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
6. can maintain a step-standing position for at least 30 seconds
7. can walk for at least 10 meters with or without device
8. no participation in further experimental rehabilitation or drug studies during the duration of the project
Exclusion Criteria
2. concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.
20 Years
80 Years
ALL
No
Sponsors
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
OTHER
Responsible Party
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Principal Investigators
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Keh-Chung Lin, Sc.D
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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Feng Yuan Hospital, Ministry of Health and Welfare
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, , Taiwan
Taipei Tzu Chi Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Keh-Chung Lin, ScD
Role: primary
Keh-Chung Lin, ScD
Role: primary
Keh-Chung Lin, ScD
Role: primary
Other Identifiers
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10-M-161
Identifier Type: -
Identifier Source: org_study_id
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