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Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01416012
Recruitment Status : Unknown
Verified June 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : August 12, 2011
Last Update Posted : April 24, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE August 12, 2011
Last Update Posted Date April 24, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
questionnaires on quality of life [ Time Frame: 16 weeks for each test ]
  • EQ-6D
  • BERG test
  • Timed Up and Go Test and dual task TUG test
  • Engagement using the Observational Assessment of Engagement (OME)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2011)
tests on health [ Time Frame: 16 weeks for each test ]
  • Trail making Test A and B
  • Visual Association Test
  • Mini Mental State Examination
  • Neuropsychiatric Inventory
  • Apathy Inventory
  • Strength of lower and upper limbs using dynamometer.
  • Rapid stepping test
  • 10 meters walk test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
Official Title  ICMJE Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
Brief Summary

Interactive games (virtual reality) have recently been the center of interest and scientific discussion in the field of cognitive and functional rehabilitation. From their entertaining and contextual aspects, off-the-shelf video games are potentially interesting tools as adjunct to the patient care, especially for maintaining instrumental activities of daily living (IADL) autonomy.

Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing health related quality of life (HRQL). This decrease in cognitive and functional abilities can be slowed down using adapted rehabilitation program.

However, there is no randomized controlled study comparing usual physical therapy to virtual reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect.

Off-the-shelf gaming consoles offer a large range of games where cognitive and functional abilities from geriatric patients could be stimulated and consequently HRQL improved.

However, a better knowledge of the potential cognitive and functional improvement processes from virtual reality rehabilitation in institutional routine is needed to enhance the quality and the range of the available care in old adults.

This study will not only be a validation platform of virtual reality as stand alone rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming consoles in HRQL improvement of old adults.

The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL changes of patients with Alzheimer disease and related disorders.

•Method

This study is a randomized controlled trial that comprises two study phases :

Phase one; comparing three parallel groups where therapists and assessors will be kept blind of study objectives, and Phase two, the investigators will take the most cost-effective gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will use it as an adjunct to physical therapy compared to physical therapy alone, with respect to the same amount of rehabilitation time.

The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after intervention.

Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or physical therapy as the 'gold' standard condition.

All groups will receive the same amount of rehabilitation time. Power and sample calculation for phase two will be based on phase one results.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Disease Alzheimer
Intervention  ICMJE
  • Behavioral: Physical Therapy (standard)
    This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement.
  • Behavioral: Balance and Gait training in Individualized sessions
    The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement.
  • Behavioral: Kinect
    The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
  • Behavioral: Group Xbox Kinect
    The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
Study Arms  ICMJE
  • Experimental: Group Kinect
    Use of the available Kinect games on the Xbox to train balance and gait
    Intervention: Behavioral: Kinect
  • Active Comparator: Physical Therapy Standard
    This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement.
    Intervention: Behavioral: Physical Therapy (standard)
  • Experimental: Group Nintendo
    Use of video games available Balance and Gait training in Individualized training sessions.
    Intervention: Behavioral: Balance and Gait training in Individualized sessions
  • Experimental: Group Xbox Kinect (MK)
    The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
    Intervention: Behavioral: Group Xbox Kinect
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 11, 2011)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to understand complex instruction
  • Patients with Mild Cognitive Impairment, Alzheimer, Vascular or Alzheimer with cerebro-vascular components dementia.

Geriatric patients with a cognitive level as described by the MMSE between 16 and 26.

  • Aged 60 and older
  • Signed informed consent (patient or career)

Inclusion criteria for investigator center

  • Having a recruitment line from Memory center, outpatient clinic, daycare, nursing homes and long term care
  • Able to include 60 patients or more
  • Have the French main investigator protocol reviewed and validated by their local ethical committee.

Exclusion Criteria:

  • Other type of dementia, psychiatric patients or patients with deemed behavioural disturbances
  • Patients using wheelchair for mobility
  • Patient with severe deficit in alertness, vision or motor functioning.
  • Bedridden patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01416012
Other Study ID Numbers  ICMJE 11-PP-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Philippe, PHD CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP