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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02553993
Enrollment
43
Registered
2015-09-18
Start date
2013-09-30
Completion date
2015-03-31
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Cognition, Exergames, Weight shifting, Balance, Rehabilitation

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.

Interventions

DEVICEWii 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.

DEVICETetrax 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.

OTHERConventional 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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in Cognitive Abilities Screening Instrument Scale Chinese version (CASI C-2.0)Subjects will be assesed at 12 weeks and 24 weeksThe 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

MeasureTime frameDescription
Change from Baseline in The modified Trail Making Test(TMT)Subjects will be assesed at 12 weeks and 24 weeksThe 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 performanceSubjects will be assesed at 12 weeks and 24 weeksThe 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)Subjects will be assesed at 12 weeks and 24 weeksThe PPA is a validated battery of sensorimotor measurements used to identify those subjects at risk of falling.
Change from Baseline in The 10m walking testSubjects will be assesed at 12 weeks and 24 weeksThe 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 The Stroop testSubjects will be assesed at 12 weeks and 24 weeksThe 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 Timed Up and Go (TUG) testSubjects will be assesed at 12 weeks and 24 weeksTimed 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)Subjects will be assesed at 12 weeks and 24 weeksThe 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 ScaleSubjects will be assesed at 12 weeks and 24 weeksThe 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)Subjects will be assesed at 12 weeks and 24 weeksThe PACES is a 18-item and 7-point self-reported scale, and the higher score has more enjoyment of the training.
Change from Baseline in Tetrax balance systemSubjects will be assesed at 12 weeks and 24 weeksTetrax balance system will be used to assess static standing balance. The lower risk scores is indicating better performance.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026