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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553993
• Other study ID #: CMRPG8C0261
• Status: Completed
• Phase: N/A
• First received: September 14, 2015
• Last updated: January 6, 2016
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
Taiwan	Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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).	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No
Secondary	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.	Subjects will be assesed at 12 weeks and 24 weeks	No

External Links

•   Nintendo. Nintendo Wii-Fit games
•   Sunlight. Tetrax balance system