Major Neurocognitive DisorderNCT04664920
An Individualized Exergame Training Solution for People With Major Neurocognitive Disorder: a Usability Study
An observational study of Major Neurocognitive Disorder and Physical Activity, run by Davy Vancampfort at 1 site in Belgium.
Trial summary
The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Major Neurocognitive Disorder, Physical Activity, Dementia
- What is being tested?
- exergame
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jun 2020to 25 Sep 2020
- Phase
- Observational
- 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
Study population: Residents of long-term care facility 'de Wingerd'.
Who may be able to join
- Aged 60+ years
- Live in long-term care facility "de Wingerd"
- Being diagnosed with major neurocognitive disorder by a specialist doctor
- Standing straight for minimal 10 minutes without aids
- Visual acuity with correction sufficient to work on a TV screen
Who cannot join
- Mobility impairments that don't allow to play the exergame
- Severe acute or uncontrolled health problems (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
- Orthopaedic or neurological diseases that inhibit Exergame training
- Rapidly progressive or terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia).
Read the detailed description
The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia). On one appointment, the participants will perform a user-centered exergame for about 30 minutes. The exergame will include specific cognitive and motor functions. As the difficulty of the training game is user-centered, the participants will always be challenged on an appropriate level. Stepping exercises will be used to control the video game scenario. The video game scenario will include different cognitive functions. The body movements will include different physical aspects including balance, strength and Pelvic Floor Muscle Training (PFMT). During the exergame performance, different qualitative assessments will be performed to determine usability of the exergame including acceptance and game experience protocol (think aloud method). After the exergame performance, the participant will answer individual and guideline-based interview questions about usability including their individual experiences (duration about 20 min). This study contributes to fundamental research investigating how user-centered exergame training can be applied in older adults with individual needs.
- Conditions
- Major Neurocognitive Disorder, Physical Activity, Dementia
- Being tested
- exergame
- Medical subject headings
- Motor Activity, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exergameDevice
motor-cognitive training device
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Exergame intervention arm. Receives: Device: exergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance questionnaire
users' individual acceptance
Measured: 2 years
Game experience questionnaire
users' game experience
Measured: 2 years
Guideline-based qualitative interview
Users' opinions and feedback
Measured: 2 years
System usability questionnaire
System usability scale
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start8 Jun 2020
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Neurocognitive DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Davy Vancampfort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Davy Vancampfort, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664920
- Sponsor's protocol ID
- 052020
- Status last verified
- Dec 2020
- First submitted
- 3 Jun 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individualized Exergame Training Solution for People With Major Neurocognitive Disorder: a Usability Study
- ClinicalTrials.gov ID
- NCT04664920
- Acronym / sponsor ID
- 052020
- Conditions
- Major Neurocognitive Disorder, Physical Activity, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Davy VancampfortUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia).
Detailed description
The aim of this study is to investigate the usability of a newly designed and developed user-centered exergame in older adults with major neurocognitive disorder (dementia). On one appointment, the participants will perform a user-centered exergame for about 30 minutes. The exergame will include specific cognitive and motor functions. As the difficulty of the training game is user-centered, the participants will always be challenged on an appropriate level. Stepping exercises will be used to control the video game scenario. The video game scenario will include different cognitive functions. The body movements will include different physical aspects including balance, strength and Pelvic Floor Muscle Training (PFMT). During the exergame performance, different qualitative assessments will be performed to determine usability of the exergame including acceptance and game experience protocol (think aloud method). After the exergame performance, the participant will answer individual and guideline-based interview questions about usability including their individual experiences (duration about 20 min). This study contributes to fundamental research investigating how user-centered exergame training can be applied in older adults with individual needs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: exergameExergame intervention arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of long-term care facility 'de Wingerd'.
Key inclusion criteria (5 listed)
- Aged 60+ years
- Live in long-term care facility "de Wingerd"
- Being diagnosed with major neurocognitive disorder by a specialist doctor
- Standing straight for minimal 10 minutes without aids
- Visual acuity with correction sufficient to work on a TV screen
Key exclusion criteria (4 listed)
- Mobility impairments that don't allow to play the exergame
- Severe acute or uncontrolled health problems (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
- Orthopaedic or neurological diseases that inhibit Exergame training
- Rapidly progressive or terminal illness
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 |
|---|---|---|
| exergamemotor-cognitive training device | Device | Intervention |
Primary outcome
Acceptance questionnaire
Time frame: 2 years
users' individual acceptance
Game experience questionnaire
Time frame: 2 years
users' game experience
Guideline-based qualitative interview
Time frame: 2 years
Users' opinions and feedback
System usability questionnaire
Time frame: 2 years
System usability scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Neurocognitive Disorder and Physical Activity, run by Davy Vancampfort at 1 site in Belgium.
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 5 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: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptance questionnaire (time frame: 2 years). The study lists 4 primary outcomes in all. 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 11 Dec 2020.