Comparing the Cognitive Effects of Two Exergame Training and Traditional Training in Patients With Chronic Stroke

Study Overview
=================
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.

Official Title
-----------------
Comparing the Cognitive Effects of Two Exergame Balance Training Systems and Traditional Weight Shifting Training in Patients With Chronic Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Wii Fit(30 Mins)
* Device: Tetrax biofeedback(30 Mins)
* Other: Conventional weight-shifting(30 Mins)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wii Fit<br>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. | Device: Wii Fit(30 Mins)<br>* Receive Wi Fit games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.<br>|
| Experimental: Tetrax biofeedback<br>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. | Device: Tetrax biofeedback(30 Mins)<br>* Receive Tetrax biofeedback games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.<br>|
| Placebo Comparator: Conventional weight-shifting<br>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 | Other: Conventional weight-shifting(30 Mins)<br>* Receive weight-shifting exercise training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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). | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 
| 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. | Subjects will be assesed at 12 weeks and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Cognition, Exergames, Weight shifting, Balance, Rehabilitation