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

• ClinicalTrials.gov Identifier: NCT01416012
• Recruitment Status: Unknown
• First Posted: August 12, 2011
• Last Update Posted: April 24, 2013
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Tracking Information

• First Submitted Date: June 30, 2011
• First Posted Date: August 12, 2011
• Last Update Posted Date: April 24, 2013
• Study Start Date: October 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
• Condition: Disease Alzheimer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 11, 2011): 180
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2013
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, France, Netherlands

Administrative Information

• NCT Number: NCT01416012
• Other Study ID Numbers: 11-PP-06
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Centre Hospitalier Universitaire de Nice
• Study Sponsor: Centre Hospitalier Universitaire de Nice
• Collaborators: Not Provided

Investigators

• 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