- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05492175
Proximal- Versus Distal-Prioritized Robotic Practice Plus Kinetic Exergaming in Stroke Rehabilitation
December 28, 2023 updated by: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
This research program aims at investigating the effects of upper-limb robotic therapy primed with interactive exergaming as an innovative hybrid regimen in stroke rehabilitation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery.
The proximal priority and distal priority robotic priming techniques may bring differential effects.
This proposed research project aims to: (1) examine the effects of proximal priority versus distal priority of bilateral robotic priming combined with exergaming on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of the three approaches, and (3) identify the potential predictors of functionally relevant changes after therapy.
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Keh-Chung Lin, Sc.D
- Phone Number: +886-3366-8180
- Email: kehchunglin@ntu.edu.tw
Study Locations
-
-
-
Taichung, Taiwan
- Recruiting
- Feng Yuan Hospital, Ministry of Health and Welfare
-
Contact:
- Keh-Chung Lin, ScD
-
Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Keh-Chung Lin, ScD
-
Taipei, Taiwan
- Recruiting
- Taipei Municipal Wan Fang Hospital
-
Contact:
- Keh-Chung Lin, ScD
-
Taipei, Taiwan
- Recruiting
- Taipei Tzu Chi Hospital
-
Contact:
- Keh-chung Lin, Sc.D
- Phone Number: +886 33668180
- Email: kehchunglin@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- a first ever-stroke≧3 months
- age range between 20 to 80 years
- baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56
- no excessive muscle spasticity of the affected extremities (Modified Ashworth Scale < 3 at any joints)
- able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22)
- can maintain a step-standing position for at least 30 seconds
- can walk for at least 10 meters with or without device
- no participation in further experimental rehabilitation or drug studies during the duration of the project
Exclusion Criteria:
- acute inflammation and pain
- concomitant neurologic, neuromuscular or orthopedic conditions that may impede participation in this research.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: proximal-prioritized robotic practice plus kinetic exergaming group
60 minutes per day, 3 days per week for 6 weeks
|
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.
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.
|
Active Comparator: distal-prioritized robotic practice plus kinetic exergaming group
60 minutes per day, 3 days per week for 6 weeks
|
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.
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.
|
Active Comparator: robotic practice plus conventional therapy group
60 minutes per day, 3 days per week for 6 weeks
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks and 18 weeks
Time Frame: Baseline, 6 weeks, and 18 weeks
|
|
Baseline, 6 weeks, and 18 weeks
|
Change from Baseline 10 meter walk test (10-MWT) at 6 weeks and 18 weeks
Time Frame: Baseline, 6 weeks, and 18 weeks
|
1.10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. 2.The total time is recorded in m/s 3.The lower total time means the greater recovery of walking speed. |
Baseline, 6 weeks, and 18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medical Research Council scale (MRC)
Time Frame: Baseline, 6 weeks, and 18 weeks
|
|
Baseline, 6 weeks, and 18 weeks
|
The ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL,USA)
Time Frame: Baseline, 6 weeks, and 18 weeks
|
|
Baseline, 6 weeks, and 18 weeks
|
Functional Independence Measure (FIM)
Time Frame: Baseline, 6 weeks, and 18 weeks
|
|
Baseline, 6 weeks, and 18 weeks
|
Stroke Self-Efficacy Questionnaire (SSEQ)
Time Frame: Baseline, 6 weeks, and 18 weeks
|
|
Baseline, 6 weeks, and 18 weeks
|
Adverse events (pain and fatigue)
Time Frame: through study completion, an average of 18 weeks
|
|
through study completion, an average of 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Keh-Chung Lin, Sc.D, National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
July 3, 2022
First Submitted That Met QC Criteria
August 4, 2022
First Posted (Actual)
August 8, 2022
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 28, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-M-161
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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