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Completed

NCT Number: NCT02553993

Comparing the Cognitive Effects of Two Exergame Training and Traditional 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Kaohsiung, Taiwan, 833

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2015
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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