An Individualized Exergame Training Solution for People With Major Neurocognitive Disorder: a Usability Study

December 10, 2020 updated by: Davy Vancampfort
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • De Wingerd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
Exergame intervention arm.
Device: exergame
motor-cognitive training device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance questionnaire
Time Frame: 2 years
users' individual acceptance
2 years
Game experience questionnaire
Time Frame: 2 years
users' game experience
2 years
Guideline-based qualitative interview
Time Frame: 2 years
Users' opinions and feedback
2 years
System usability questionnaire
Time Frame: 2 years
System usability scale
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Davy Vancampfort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2020

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

September 25, 2020

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 052020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe