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

January 6, 2016 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Subjects will be assesed at 12 weeks and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
The digit backward performance requires attention and working memory. The scores range from 2 to 7 higher scores indicating better performance.
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
The PPA is a validated battery of sensorimotor measurements used to identify those subjects at risk of falling.
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
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.
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
Tetrax balance system will be used to assess static standing balance. The lower risk scores is indicating better performance.
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
Timed Up and Go (TUG) test will be used to assessed Dynamic balance function. The shorter time it take means better performance.
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
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).
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
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.
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
The PACES is a 18-item and 7-point self-reported scale, and the higher score has more enjoyment of the training.
Subjects will be assesed at 12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Jen-Wen Hung, MD, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Publications and helpful links

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General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

September 17, 2015

First Posted (Estimate)

September 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8C0261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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