Disease AlzheimerNCT01416012
Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
A study testing Physical Therapy (standard), Balance and Gait training in Individualized sessions and Kinect in people with Disease Alzheimer, run by Centre Hospitalier Universitaire de Nice at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Disease Alzheimer
- What is being tested?
- Physical Therapy (standard), Balance and Gait training in Individualized sessions and Kinect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
Nice, Alpes-Maritimes, 06001
About this study
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.
Read more
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
- Being tested
- Physical Therapy (standard), Balance and Gait training in Individualized sessions, Kinect, Group Xbox Kinect
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy (standard)Behavioural
This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement.
Balance and Gait training in Individualized sessionsBehavioural
The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement.
KinectBehavioural
The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
Group Xbox KinectBehavioural
The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Group Kinect | Experimental | Use of the available Kinect games on the Xbox to train balance and gait Receives: 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. Receives: Behavioral: Physical Therapy (standard) |
| Group Nintendo | Experimental | Use of video games available Balance and Gait training in Individualized training sessions. Receives: 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 Receives: Behavioral: Group Xbox Kinect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks for each test
Secondary outcomes (1)
tests on health
- 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
Measured: 16 weeks for each test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease AlzheimerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Philippe, PHD, Principal investigator, CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416012
- Sponsor's protocol ID
- 11-PP-06
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2011
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations
- ClinicalTrials.gov ID
- NCT01416012
- Acronym / sponsor ID
- 11-PP-06
- Conditions
- Disease Alzheimer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Kinect | Experimental | Behavioral: KinectUse of the available Kinect games on the Xbox to train balance and gait |
| Physical Therapy Standard | Active comparator | 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. |
| Group Nintendo | Experimental | Behavioral: Balance and Gait training in Individualized sessionsUse of video games available Balance and Gait training in Individualized training sessions. |
| Group Xbox Kinect (MK) | Experimental | Behavioral: Group Xbox KinectThe NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy (standard)This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement. | Behavioural | Physical Therapy Standard |
| Balance and Gait training in Individualized sessionsThe NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement. | Behavioural | Group Nintendo |
| KinectThe NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement | Behavioural | Group Kinect |
| Group Xbox KinectThe NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement | Behavioural | Group Xbox Kinect (MK) |
Primary outcome
questionnaires on quality of life
Time frame: 16 weeks for each test
* EQ-6D * BERG test * Timed Up and Go Test and dual task TUG test * Engagement using the Observational Assessment of Engagement (OME)
1 secondary outcome
tests on health
Time frame: 16 weeks for each test
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Philippe, PHD principal investigator
CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy (standard), Balance and Gait training in Individualized sessions and Kinect in people with Disease Alzheimer, run by Centre Hospitalier Universitaire de Nice at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaires on quality of life (time frame: 16 weeks for each test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.