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

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ClinicalTrials.gov Identifier: NCT02553993
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Device: Wii Fit(30 Mins) Device: Tetrax biofeedback(30 Mins) Other: Conventional weight-shifting(30 Mins) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Cognitive Effects of Two Exergame Balance Training Systems and Traditional Weight Shifting Training in Patients With Chronic Stroke
Study Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Wii Fit
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)
Receive Wi Fit games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.

Experimental: Tetrax biofeedback

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)
Receive Tetrax biofeedback games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.

Placebo Comparator: Conventional weight-shifting
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)
Receive weight-shifting exercise training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.




Primary Outcome Measures :
  1. Change from Baseline in Cognitive Abilities Screening Instrument Scale Chinese version (CASI C-2.0) [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    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 :
  1. Change from Baseline in The Stroop test [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    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.

  2. Change from Baseline in The modified Trail Making Test(TMT) [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    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.

  3. Change from Baseline in The digit backward performance [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    The digit backward performance requires attention and working memory. The scores range from 2 to 7 higher scores indicating better performance.

  4. Change from Baseline in Physiological profile assessment(PPA) [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    The PPA is a validated battery of sensorimotor measurements used to identify those subjects at risk of falling.

  5. Change from Baseline in The 10m walking test [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    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.

  6. Change from Baseline in Tetrax balance system [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    Tetrax balance system will be used to assess static standing balance. The lower risk scores is indicating better performance.

  7. Change from Baseline in Timed Up and Go (TUG) test [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    Timed Up and Go (TUG) test will be used to assessed Dynamic balance function. The shorter time it take means better performance.

  8. Change from Baseline in The Frenchay Activities Index (FAI) [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    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).

  9. Change from Baseline in Stroke Impact Scale [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    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.

  10. Change from Baseline in Physical Activity Enjoyment Scale (PACES) [ Time Frame: Subjects will be assesed at 12 weeks and 24 weeks ]
    The PACES is a 18-item and 7-point self-reported scale, and the higher score has more enjoyment of the training.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553993


Locations
Taiwan
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Jen-Wen Hung, MD Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Additional Information:
Publications:
Lieberman DA. Designing serious games for learning and health in informal and formal settings. In: Ritterfeld U, Cody MJ, Vorderer P, editors. Serious games: mechanisms and effects. New York: Routledge; 2009. p 117-30.

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02553993     History of Changes
Other Study ID Numbers: CMRPG8C0261
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: September 2015

Keywords provided by Chang Gung Memorial Hospital:
Stroke
Cognition
Exergames
Weight shifting
Balance
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases