NCT04664920

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 3, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

June 3, 2020

Last Update Submit

December 10, 2020

Conditions

Major Neurocognitive DisorderPhysical ActivityDementia

Outcome Measures

Primary Outcomes (4)

  • Acceptance questionnaire

    users' individual acceptance

    2 years

  • Game experience questionnaire

    users' game experience

    2 years

  • Guideline-based qualitative interview

    Users' opinions and feedback

    2 years

  • System usability questionnaire

    System usability scale

    2 years

Study Arms (1)

Intervention

Exergame intervention arm.

Device: exergame

Interventions

exergameDEVICE

motor-cognitive training device

Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of long-term care facility 'de Wingerd'.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

De Wingerd

Leuven, Vlaams Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Motor ActivityDementia

Condition Hierarchy (Ancestors)

BehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2020

First Posted

December 11, 2020

Study Start

June 8, 2020

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)