Back to resultsComparing the Cognitive Effects of Two Exergame Training and Traditional Training in Patients With Chronic Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Wii Fit(30 Mins)
Tetrax biofeedback(30 Mins)
Conventional weight-shifting(30 Mins)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Cognition, Exergames, Weight shifting, Balance, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Post-stroke duration of at least 6 months
- Ability to understand verbal instructions and learn
- Adequate visual acuity (with appropriate correction, if necessary)
- Ability to walk independently with or without device
Exclusion Criteria:
- Bilateral hemispheric
- Cerebellar lesions
- Aphasia
- Significant visual field deficits
- Hemineglect
- History of orthopedic
- Other neurological diseases
- Medical conditions that would prevent adherence to the exercise protocol
Sites / Locations
- Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Wii Fit
Tetrax biofeedback
Conventional weight-shifting
Arm Description
The Wii Fit training was conducted using the Wii Fit bundle from Nintendo, which consists of the Wii console, a Wii Balance Board, and the Wii Fit Plus balance game disc. The Wii balance board has 4 transducers, which could assess the player's force distribution and resultant movements in the center of pressure (COP). The participants stood on the board and used the change of COP to play the games. Five games (Tilt, Soccer Heading, Balance Bubble, Penguin Slide, and Perfect 10) were selected from the Wii Fit Plus package based on the motor demand of these games. The major movement patterns to play the games included right-left weight shifting and front-back weight shifting.
The Tetrax biofeedback games aimed at postural rehabilitation to help patients or athletes improve their balance abilities. There were 11 games in Tetrax system; 8 games (Speedtrack, Catch, Skyball, Gotcha, Speedball, Tag, Freeze, Immobilizer) were chosen based on the same principle as those used for choosing Wii Fit games. The parameters of games' difficulties included target size and/or speed of target movement, which could be adjusted according to the patients' ability. For the Wii Fit or Tetrax group, at each session, the supervising therapist chose 3 to 5 games for participants according to their ability, needs, and favorites.
The conventional weight-shifting exercise group performed balance exercises with the similar movements and time required by the 2 exergame systems but without video games. By using occupational activities, participants did weight shifting in the sagittal and frontal planes. The investigators also used a balance board (Reebok Core board) for multi-directional weight shifting training
Outcomes
Primary Outcome Measures
Change from Baseline in Cognitive Abilities Screening Instrument Scale Chinese version (CASI C-2.0)
The CASI C-2.0 consists of 20 item sets, which can be divided into 9 domains, including long-term memory, short-term memory, attention, concentration or mental manipulation, orientation, abstraction/judgment, language, visual construction, and category fluency. The CASI scores range from 0 to 100, with higher scores indicating better cognitive performance.
Secondary Outcome Measures
Change from Baseline in The Stroop test
The Stroop test requires selective attention, response inhibition, and working memory. The Stroop score ranges from 0 to 63, with higher scores indicating better performance.
Change from Baseline in The modified Trail Making Test(TMT)
The modified Trail Making Test (TMT) requires visual scanning, visuo-motor tracking, divided attention, and cognitive flexibility. The shorter time to complete the test means better performance.
Change from Baseline in The digit backward performance
The digit backward performance requires attention and working memory. The scores range from 2 to 7 higher scores indicating better performance.
Change from Baseline in Physiological profile assessment(PPA)
The PPA is a validated battery of sensorimotor measurements used to identify those subjects at risk of falling.
Change from Baseline in The 10m walking test
The 10m WT is a reliable, valid, and responsive measure for sub-acute stroke. Walking speed will be assessed by self-selected gait speed over 10 m. The shorter time it takes is indicating better performance.
Change from Baseline in Tetrax balance system
Tetrax balance system will be used to assess static standing balance. The lower risk scores is indicating better performance.
Change from Baseline in Timed Up and Go (TUG) test
Timed Up and Go (TUG) test will be used to assessed Dynamic balance function. The shorter time it take means better performance.
Change from Baseline in The Frenchay Activities Index (FAI)
The Frenchay Activities Index (FAI) was used as a measure of subjects' participation level. The 15-item index records the frequency of performing social activities as well as more complex activities of daily living (eg, domestic chores, outdoor mobility, leisure, gainful work). The FAI item score is based on the frequency with which an activity was performed, and ranges from 0 (low frequency) to 3 (high frequency). Ten items concern the past 3 months and 5 items concern the past 6 months. The FAI total score is the sum of item scores, and ranges from 0 (inactive) to 45 (highly active).
Change from Baseline in Stroke Impact Scale
The Stroke Impact Scale (SIS) is a 59-item self-reported scale with good reliability, validity, and sensitivity to change. The SIS consists of 8 functional domains: strength, memory, emotion, communication, ADL/ instrumental ADL (IADL), mobility, hand function, and participation. The overall SIS score represents the average score of the 8 domains. Each item score ranges from 1 to 5. Each domain score has a range of 0 to 100 and is computed by using the following equation: Score =[(Mean - 1)/(5 - 1)] × 100. In this equation, the score is that of a particular domain, and the mean is the average of the item scores within that domain. A higher score on an item denotes better performance.
Change from Baseline in Physical Activity Enjoyment Scale (PACES)
The PACES is a 18-item and 7-point self-reported scale, and the higher score has more enjoyment of the training.
Full Information
NCT ID
NCT02553993
First Posted
September 14, 2015
Last Updated
January 6, 2016
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02553993
Brief Title
Comparing the Cognitive Effects of Two Exergame Training and Traditional Training in Patients With Chronic Stroke
Official Title
Comparing the Cognitive Effects of Two Exergame Balance Training Systems and Traditional Weight Shifting Training in Patients With Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study was to: compare the training and maintenance effects of 3 balance training programs (2 kinds of exergame systems and 1 conventional weight-shifting training program) on cognitive function of subjects with chronic stroke.
Detailed Description
The objective of this study was to: compare the training and maintenance effects of 3 balance training programs (2 kinds of exergame systems and 1 conventional weight-shifting training program) on cognitive function of subjects with chronic stroke. We hypothesized that the exergaming program using weight shifting as game controller is better than the weight shifting only program. The investigators further hypothesized that exergames designed for entertainment (such as Wii Fit) are more beneficial than exergames for rehabilitation purpose (such as Tetrax biofeedback) in gain of cognition function for patients with chronic stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Cognition, Exergames, Weight shifting, Balance, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wii Fit
Arm Type
Experimental
Arm Description
The Wii Fit training was conducted using the Wii Fit bundle from Nintendo, which consists of the Wii console, a Wii Balance Board, and the Wii Fit Plus balance game disc. The Wii balance board has 4 transducers, which could assess the player's force distribution and resultant movements in the center of pressure (COP). The participants stood on the board and used the change of COP to play the games. Five games (Tilt, Soccer Heading, Balance Bubble, Penguin Slide, and Perfect 10) were selected from the Wii Fit Plus package based on the motor demand of these games. The major movement patterns to play the games included right-left weight shifting and front-back weight shifting.
Arm Title
Tetrax biofeedback
Arm Type
Experimental
Arm Description
The Tetrax biofeedback games aimed at postural rehabilitation to help patients or athletes improve their balance abilities. There were 11 games in Tetrax system; 8 games (Speedtrack, Catch, Skyball, Gotcha, Speedball, Tag, Freeze, Immobilizer) were chosen based on the same principle as those used for choosing Wii Fit games. The parameters of games' difficulties included target size and/or speed of target movement, which could be adjusted according to the patients' ability.
For the Wii Fit or Tetrax group, at each session, the supervising therapist chose 3 to 5 games for participants according to their ability, needs, and favorites.
Arm Title
Conventional weight-shifting
Arm Type
Placebo Comparator
Arm Description
The conventional weight-shifting exercise group performed balance exercises with the similar movements and time required by the 2 exergame systems but without video games. By using occupational activities, participants did weight shifting in the sagittal and frontal planes. The investigators also used a balance board (Reebok Core board) for multi-directional weight shifting training
Intervention Type
Device
Intervention Name(s)
Wii Fit(30 Mins)
Intervention Description
Receive Wi Fit games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
Intervention Type
Device
Intervention Name(s)
Tetrax biofeedback(30 Mins)
Intervention Description
Receive Tetrax biofeedback games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
Intervention Type
Other
Intervention Name(s)
Conventional weight-shifting(30 Mins)
Intervention Description
Receive weight-shifting exercise training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in Cognitive Abilities Screening Instrument Scale Chinese version (CASI C-2.0)
Description
The CASI C-2.0 consists of 20 item sets, which can be divided into 9 domains, including long-term memory, short-term memory, attention, concentration or mental manipulation, orientation, abstraction/judgment, language, visual construction, and category fluency. The CASI scores range from 0 to 100, with higher scores indicating better cognitive performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in The Stroop test
Description
The Stroop test requires selective attention, response inhibition, and working memory. The Stroop score ranges from 0 to 63, with higher scores indicating better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in The modified Trail Making Test(TMT)
Description
The modified Trail Making Test (TMT) requires visual scanning, visuo-motor tracking, divided attention, and cognitive flexibility. The shorter time to complete the test means better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in The digit backward performance
Description
The digit backward performance requires attention and working memory. The scores range from 2 to 7 higher scores indicating better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in Physiological profile assessment(PPA)
Description
The PPA is a validated battery of sensorimotor measurements used to identify those subjects at risk of falling.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in The 10m walking test
Description
The 10m WT is a reliable, valid, and responsive measure for sub-acute stroke. Walking speed will be assessed by self-selected gait speed over 10 m. The shorter time it takes is indicating better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in Tetrax balance system
Description
Tetrax balance system will be used to assess static standing balance. The lower risk scores is indicating better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in Timed Up and Go (TUG) test
Description
Timed Up and Go (TUG) test will be used to assessed Dynamic balance function. The shorter time it take means better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in The Frenchay Activities Index (FAI)
Description
The Frenchay Activities Index (FAI) was used as a measure of subjects' participation level. The 15-item index records the frequency of performing social activities as well as more complex activities of daily living (eg, domestic chores, outdoor mobility, leisure, gainful work). The FAI item score is based on the frequency with which an activity was performed, and ranges from 0 (low frequency) to 3 (high frequency). Ten items concern the past 3 months and 5 items concern the past 6 months. The FAI total score is the sum of item scores, and ranges from 0 (inactive) to 45 (highly active).
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in Stroke Impact Scale
Description
The Stroke Impact Scale (SIS) is a 59-item self-reported scale with good reliability, validity, and sensitivity to change. The SIS consists of 8 functional domains: strength, memory, emotion, communication, ADL/ instrumental ADL (IADL), mobility, hand function, and participation. The overall SIS score represents the average score of the 8 domains. Each item score ranges from 1 to 5. Each domain score has a range of 0 to 100 and is computed by using the following equation: Score =[(Mean - 1)/(5 - 1)] × 100. In this equation, the score is that of a particular domain, and the mean is the average of the item scores within that domain. A higher score on an item denotes better performance.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
Title
Change from Baseline in Physical Activity Enjoyment Scale (PACES)
Description
The PACES is a 18-item and 7-point self-reported scale, and the higher score has more enjoyment of the training.
Time Frame
Subjects will be assesed at 12 weeks and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Post-stroke duration of at least 6 months
Ability to understand verbal instructions and learn
Adequate visual acuity (with appropriate correction, if necessary)
Ability to walk independently with or without device
Exclusion Criteria:
Bilateral hemispheric
Cerebellar lesions
Aphasia
Significant visual field deficits
Hemineglect
History of orthopedic
Other neurological diseases
Medical conditions that would prevent adherence to the exercise protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jen-Wen Hung, MD
Organizational Affiliation
Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
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Links:
URL
http://www.nintendo.com/
Description
Nintendo. Nintendo Wii-Fit games
URL
http://www.sunlightnet.com/International/html/TetraxBiofeedback.html
Description
Sunlight. Tetrax balance system
Learn more about this trial
Comparing the Cognitive Effects of Two Exergame Training and Traditional Training in Patients With Chronic Stroke
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