Clinical trial NCT02553993: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Cognition
Exergames
Weight shifting
Balance
Rehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in Cognitive Abilities Screening Instrument Scale Chinese version (CASI C-2.0)
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
Secondary outcomes:
measure: Change from Baseline in The Stroop test
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in The modified Trail Making Test(TMT)
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in The digit backward performance
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in Physiological profile assessment(PPA)
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in The 10m walking test
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in Tetrax balance system
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in Timed Up and Go (TUG) test
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in The Frenchay Activities Index (FAI)
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in Stroke Impact Scale
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
measure: Change from Baseline in Physical Activity Enjoyment Scale (PACES)
timeFrame: Subjects will be assesed at 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Study officials:
affiliation: Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
name: Jen-Wen Hung, MD
role: PRINCIPAL_INVESTIGATOR
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