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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01416012




Registration number
NCT01416012
Ethics application status
Date submitted
30/06/2011
Date registered
12/08/2011
Date last updated
18/03/2024

Titles & IDs
Public title
Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
Scientific title
Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
Secondary ID [1] 0 0
11-PP-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disease Alzheimer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Physical Therapy (standard)
Behaviour - Balance and Gait training in Individualized sessions
Behaviour - Kinect
Behaviour - Group Xbox Kinect

Experimental: Group Kinect - Use of the available Kinect games on the Xbox to train balance and gait

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.

Experimental: Group Nintendo - Use of video games available Balance and Gait training in Individualized training 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


Behaviour: Physical Therapy (standard)
This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement.

Behaviour: 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.

Behaviour: Kinect
The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement

Behaviour: 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
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
questionnaires on quality of life
Timepoint [1] 0 0
16 weeks for each test
Secondary outcome [1] 0 0
tests on health
Timepoint [1] 0 0
16 weeks for each test

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The University of Queensland - St Lucia
Recruitment postcode(s) [1] 0 0
- St Lucia
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Alpes-Maritimes
Country [2] 0 0
Netherlands
State/province [2] 0 0
Nijmegen

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Hospitalier Universitaire de Nice
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01416012
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Philippe, PHD
Address 0 0
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01416012