NCT01416012

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 Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 18, 2024

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

June 30, 2011

Last Update Submit

March 15, 2024

Conditions

Disease Alzheimer

Outcome Measures

Primary Outcomes (1)

  • questionnaires on quality of life

    * EQ-6D * BERG test * Timed Up and Go Test and dual task TUG test * Engagement using the Observational Assessment of Engagement (OME)

    16 weeks for each test

Secondary Outcomes (1)

  • tests on health

    16 weeks for each test

Study Arms (4)

Group Kinect

EXPERIMENTAL

Use of the available Kinect games on the Xbox to train balance and gait

Behavioral: Kinect

Physical Therapy Standard

ACTIVE COMPARATOR

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)

Group Nintendo

EXPERIMENTAL

Use of video games available Balance and Gait training in Individualized training sessions.

Behavioral: Balance and Gait training in Individualized sessions

Group Xbox Kinect (MK)

EXPERIMENTAL

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

Interventions

Physical Therapy (standard)BEHAVIORAL

This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement.

Physical Therapy Standard
Balance and Gait training in Individualized sessionsBEHAVIORAL

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

Group Nintendo
KinectBEHAVIORAL

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

Group Kinect
Group Xbox KinectBEHAVIORAL

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

Group Xbox Kinect (MK)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The University of Queensland

Saint Lucia, Australia

Location

CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez

Nice, Alpes-Maritimes, 06001, France

Location

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Robert Philippe, PHD

    CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2011

First Posted

August 12, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2011

Study Completion

January 1, 2014

Last Updated

March 18, 2024

Record last verified: 2014-06

Locations

AU(1)FR(1)NL(1)