Clinical trial NCT01416012: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Disease Alzheimer
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: questionnaires on quality of life
timeFrame: 16 weeks for each test
Secondary outcomes:
measure: tests on health
timeFrame: 16 weeks for each test
Other outcomes:
Locations:
city: St Lucia
country: Australia
facility: The University of Queensland
city: Nice
country: France
facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
state: Alpes-Maritimes
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
name: Robert Philippe, PHD
role: PRINCIPAL_INVESTIGATOR
References: