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

NCT01416012 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

  • Disease Alzheimer

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Robert Philippe, PHD · CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-10-31
Completion
2014-01-31

Countries

  • Australia
  • France
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01416012 on ClinicalTrials.gov