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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01416012
First received: June 30, 2011
Last updated: April 23, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention
Disease Alzheimer
Behavioral: Physical Therapy (standard)
Behavioral: Balance and Gait training in Individualized sessions
Behavioral: Kinect
Behavioral: Group Xbox Kinect

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • questionnaires on quality of life [ Time Frame: 16 weeks for each test ] [ Designated as safety issue: No ]
    • EQ-6D
    • BERG test
    • Timed Up and Go Test and dual task TUG test
    • Engagement using the Observational Assessment of Engagement (OME)


Secondary Outcome Measures:
  • tests on health [ Time Frame: 16 weeks for each test ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 180
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Kinect
Use of the available Kinect games on the Xbox to train balance and gait
Behavioral: Kinect
The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
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.
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.
Experimental: Group Nintendo
Use of video games available Balance and Gait training in Individualized training sessions.
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.
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
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416012

Contacts
Contact: Robert Philippe, PhD +33492034770 robert.p@chu-nice.fr
Contact: dechamps Arnaud dechamps.a@chu-nice.fr

Locations
Australia
The University of Queensland Recruiting
St Lucia, Australia
Contact: Nitz Jennifer, PhD       nitz@uq.edu.au   
Principal Investigator: Nitz Jennifer, PhD         
France
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez Recruiting
Nice, Alpes-Maritimes, France, 06001
Contact: ROBERT Philippe, PU-PH    +33492034770    robert.p@chu-nice.fr   
Contact: Dechamps Arnaud    +33492034770    dechamps.a@chu-nice.fr   
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands
Contact: Kessels Roy, PhD    +31 24 3666196 ext +31 24 3617408    r.kessels@mps.umcn.nl   
Principal Investigator: Kessels Roy, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Robert Philippe, PHD CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01416012     History of Changes
Other Study ID Numbers: 11-PP-06
Study First Received: June 30, 2011
Last Updated: April 23, 2013
Health Authority: French : Afssaps French Health Products Safety Agency

ClinicalTrials.gov processed this record on April 17, 2014