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

NCT02553993 | Completed DMC

• 1 other identifier: CMRPG8C0261
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Cognition; Exergames; Weight shifting; Balance; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change from Baseline in The Stroop test

  Subjects will be assesed at 12 weeks and 24 weeks

• Change from Baseline in The modified Trail Making Test(TMT)

  Subjects will be assesed at 12 weeks and 24 weeks

• Change from Baseline in The digit backward performance

  Subjects will be assesed at 12 weeks and 24 weeks

• Change from Baseline in Physiological profile assessment(PPA)

  Subjects will be assesed at 12 weeks and 24 weeks

• Change from Baseline in The 10m walking test

  Subjects will be assesed at 12 weeks and 24 weeks

Study Arms (3)

Wii Fit

EXPERIMENTAL

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)

Tetrax biofeedback

EXPERIMENTAL

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)

Conventional weight-shifting

PLACEBO COMPARATOR

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)

Interventions

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.

Wii Fit

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.

Tetrax biofeedback

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.

Conventional weight-shifting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

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

Kaohsiung, Taiwan, 833, Taiwan

Location

Related Publications (37)

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Related Links

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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Jen-Wen Hung, MD

  Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2015-09

Locations

TW (1)