StrokeNCT02553993
Comparing the Cognitive Effects of Two Exergame Training and Traditional Training in Patients With Chronic Stroke
A study testing Wii Fit(30 Mins), Tetrax biofeedback(30 Mins) and Conventional weight-shifting(30 Mins) in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Wii Fit(30 Mins), Tetrax biofeedback(30 Mins) and Conventional weight-shifting(30 Mins)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Kaohsiung, Taiwan, 833
About this study
Official title: Comparing the Cognitive Effects of Two Exergame Balance Training Systems and Traditional Weight Shifting Training in Patients With Chronic Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Wii Fit(30 Mins), Tetrax biofeedback(30 Mins), Conventional weight-shifting(30 Mins)
- Keywords
- Stroke, Cognition, Exergames, Weight shifting, Balance, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii Fit(30 Mins)Device
Receive Wi Fit games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
Tetrax biofeedback(30 Mins)Device
Receive Tetrax biofeedback games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
Conventional weight-shifting(30 Mins)Other
Receive weight-shifting exercise training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Wii Fit | Experimental | 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. Receives: Device: Wii Fit(30 Mins) |
| Tetrax biofeedback | Experimental | 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. Receives: Device: Tetrax biofeedback(30 Mins) |
| Conventional weight-shifting | Placebo comparator | 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 Receives: Other: Conventional weight-shifting(30 Mins) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects will be assesed at 12 weeks and 24 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Subjects will be assesed at 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jen-Wen Hung, MD, Principal investigator, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553993
- Sponsor's protocol ID
- CMRPG8C0261
- Status last verified
- Sep 2015
- First submitted
- 14 Sep 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zinn S, Dudley TK, Bosworth HB, Hoenig HM, Duncan PW, Horner RD. The effect of poststroke cognitive impairment on rehabilitation process and functional outcome. Arch Phys Med Rehabil. 2004 Jul;85(7):1084-90. doi: 10.1016/j.apmr.2003.10.022.
PubMed 15241754Mok VC, Wong A, Lam WW, Fan YH, Tang WK, Kwok T, Hui AC, Wong KS. Cognitive impairment and functional outcome after stroke associated with small vessel disease. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):560-6. doi: 10.1136/jnnp.2003.015107.
PubMed 15026497Nys GM, van Zandvoort MJ, de Kort PL, Jansen BP, de Haan EH, Kappelle LJ. Cognitive disorders in acute stroke: prevalence and clinical determinants. Cerebrovasc Dis. 2007;23(5-6):408-16. doi: 10.1159/000101464. Epub 2007 Apr 2.
PubMed 17406110Nys GM, van Zandvoort MJ, de Kort PL, van der Worp HB, Jansen BP, Algra A, de Haan EH, Kappelle LJ. The prognostic value of domain-specific cognitive abilities in acute first-ever stroke. Neurology. 2005 Mar 8;64(5):821-7. doi: 10.1212/01.WNL.0000152984.28420.5A.
PubMed 15753416Tatemichi TK, Paik M, Bagiella E, Desmond DW, Pirro M, Hanzawa LK. Dementia after stroke is a predictor of long-term survival. Stroke. 1994 Oct;25(10):1915-9. doi: 10.1161/01.str.25.10.1915.
PubMed 8091433Hobson P, Meara J. Cognitive function and mortality in a community-based elderly cohort of first-ever stroke survivors and control subjects. J Stroke Cerebrovasc Dis. 2010 Sep-Oct;19(5):382-7. doi: 10.1016/j.jstrokecerebrovasdis.2009.07.006. Epub 2010 May 15.
PubMed 20472471Pasquini M, Leys D, Rousseaux M, Pasquier F, Henon H. Influence of cognitive impairment on the institutionalisation rate 3 years after a stroke. J Neurol Neurosurg Psychiatry. 2007 Jan;78(1):56-9. doi: 10.1136/jnnp.2006.102533. Epub 2006 Sep 4.
PubMed 16952914Pollock A, St George B, Fenton M, Firkins L. Top ten research priorities relating to life after stroke. Lancet Neurol. 2012 Mar;11(3):209. doi: 10.1016/S1474-4422(12)70029-7. No abstract available.
PubMed 22341029Rand D, Eng JJ, Liu-Ambrose T, Tawashy AE. Feasibility of a 6-month exercise and recreation program to improve executive functioning and memory in individuals with chronic stroke. Neurorehabil Neural Repair. 2010 Oct;24(8):722-9. doi: 10.1177/1545968310368684. Epub 2010 May 11.
PubMed 20460494Quaney BM, Boyd LA, McDowd JM, Zahner LH, He J, Mayo MS, Macko RF. Aerobic exercise improves cognition and motor function poststroke. Neurorehabil Neural Repair. 2009 Nov;23(9):879-85. doi: 10.1177/1545968309338193. Epub 2009 Jun 18.
PubMed 19541916Marzolini S, Oh P, McIlroy W, Brooks D. The effects of an aerobic and resistance exercise training program on cognition following stroke. Neurorehabil Neural Repair. 2013 Jun;27(5):392-402. doi: 10.1177/1545968312465192. Epub 2012 Nov 16.
PubMed 23161865Feng J, Spence I, Pratt J. Playing an action video game reduces gender differences in spatial cognition. Psychol Sci. 2007 Oct;18(10):850-5. doi: 10.1111/j.1467-9280.2007.01990.x.
PubMed 17894600Green CS, Bavelier D. Action video game modifies visual selective attention. Nature. 2003 May 29;423(6939):534-7. doi: 10.1038/nature01647.
PubMed 12774121Franceschini S, Gori S, Ruffino M, Viola S, Molteni M, Facoetti A. Action video games make dyslexic children read better. Curr Biol. 2013 Mar 18;23(6):462-6. doi: 10.1016/j.cub.2013.01.044. Epub 2013 Feb 28.
PubMed 23453956Lieberman 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Cognitive Effects of Two Exergame Balance Training Systems and Traditional Weight Shifting Training in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT02553993
- Acronym / sponsor ID
- CMRPG8C0261
- Conditions
- Stroke
- Keywords
- Stroke, Cognition, Exergames, Weight shifting, Balance, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wii Fit | Experimental | Device: Wii Fit(30 Mins)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. |
| Tetrax biofeedback | Experimental | Device: Tetrax biofeedback(30 Mins)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. |
| Conventional weight-shifting | Placebo comparator | Other: Conventional weight-shifting(30 Mins)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Bilateral hemispheric
- Cerebellar lesions
- Aphasia
- Significant visual field deficits
- Hemineglect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Wii Fit |
| 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. | Device | Tetrax biofeedback |
| 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. | Other | Conventional weight-shifting |
Primary outcome
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.
10 secondary outcomes
Change from Baseline in The Stroop test
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in The modified Trail Making Test(TMT)
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in The digit backward performance
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in Physiological profile assessment(PPA)
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in The 10m walking test
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in Tetrax balance system
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in Timed Up and Go (TUG) test
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in The Frenchay Activities Index (FAI)
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in Stroke Impact Scale
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Change from Baseline in Physical Activity Enjoyment Scale (PACES)
Time frame: Subjects will be assesed at 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
- Background: PubMed 15241754Zinn S, Dudley TK, Bosworth HB, Hoenig HM, Duncan PW, Horner RD. The effect of poststroke cognitive impairment on rehabilitation process and functional outcome. Arch Phys Med Rehabil. 2004 Jul;85(7):1084-90. doi: 10.1016/j.apmr.2003.10.022.
- Background: PubMed 15026497Mok VC, Wong A, Lam WW, Fan YH, Tang WK, Kwok T, Hui AC, Wong KS. Cognitive impairment and functional outcome after stroke associated with small vessel disease. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):560-6. doi: 10.1136/jnnp.2003.015107.
- Background: PubMed 17406110Nys GM, van Zandvoort MJ, de Kort PL, Jansen BP, de Haan EH, Kappelle LJ. Cognitive disorders in acute stroke: prevalence and clinical determinants. Cerebrovasc Dis. 2007;23(5-6):408-16. doi: 10.1159/000101464. Epub 2007 Apr 2.
- Background: PubMed 15753416Nys GM, van Zandvoort MJ, de Kort PL, van der Worp HB, Jansen BP, Algra A, de Haan EH, Kappelle LJ. The prognostic value of domain-specific cognitive abilities in acute first-ever stroke. Neurology. 2005 Mar 8;64(5):821-7. doi: 10.1212/01.WNL.0000152984.28420.5A.
- Background: PubMed 8091433Tatemichi TK, Paik M, Bagiella E, Desmond DW, Pirro M, Hanzawa LK. Dementia after stroke is a predictor of long-term survival. Stroke. 1994 Oct;25(10):1915-9. doi: 10.1161/01.str.25.10.1915.
- Background: PubMed 20472471Hobson P, Meara J. Cognitive function and mortality in a community-based elderly cohort of first-ever stroke survivors and control subjects. J Stroke Cerebrovasc Dis. 2010 Sep-Oct;19(5):382-7. doi: 10.1016/j.jstrokecerebrovasdis.2009.07.006. Epub 2010 May 15.
- Background: PubMed 16952914Pasquini M, Leys D, Rousseaux M, Pasquier F, Henon H. Influence of cognitive impairment on the institutionalisation rate 3 years after a stroke. J Neurol Neurosurg Psychiatry. 2007 Jan;78(1):56-9. doi: 10.1136/jnnp.2006.102533. Epub 2006 Sep 4.
- Background: PubMed 22341029Pollock A, St George B, Fenton M, Firkins L. Top ten research priorities relating to life after stroke. Lancet Neurol. 2012 Mar;11(3):209. doi: 10.1016/S1474-4422(12)70029-7. No abstract available.
- Background: PubMed 20460494Rand D, Eng JJ, Liu-Ambrose T, Tawashy AE. Feasibility of a 6-month exercise and recreation program to improve executive functioning and memory in individuals with chronic stroke. Neurorehabil Neural Repair. 2010 Oct;24(8):722-9. doi: 10.1177/1545968310368684. Epub 2010 May 11.
- Background: PubMed 19541916Quaney BM, Boyd LA, McDowd JM, Zahner LH, He J, Mayo MS, Macko RF. Aerobic exercise improves cognition and motor function poststroke. Neurorehabil Neural Repair. 2009 Nov;23(9):879-85. doi: 10.1177/1545968309338193. Epub 2009 Jun 18.
- Background: PubMed 23161865Marzolini S, Oh P, McIlroy W, Brooks D. The effects of an aerobic and resistance exercise training program on cognition following stroke. Neurorehabil Neural Repair. 2013 Jun;27(5):392-402. doi: 10.1177/1545968312465192. Epub 2012 Nov 16.
- Background: PubMed 17894600Feng J, Spence I, Pratt J. Playing an action video game reduces gender differences in spatial cognition. Psychol Sci. 2007 Oct;18(10):850-5. doi: 10.1111/j.1467-9280.2007.01990.x.
- Nintendo. Nintendo Wii-Fit gamesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Wen Hung, MD principal investigator
Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wii Fit(30 Mins), Tetrax biofeedback(30 Mins) and Conventional weight-shifting(30 Mins) in people with Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553993, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.