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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664920
• Other study ID #: 052020
• Status: Completed
• Start date: June 8, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: December 2020
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Major Neurocognitive Disorder
• Neurocognitive Disorders
• Physical Activity

Intervention

Device:
• exergame
motor-cognitive training device

Locations

Country	Name	City	State
Belgium	De Wingerd	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Davy Vancampfort

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance questionnaire	users' individual acceptance	2 years
Primary	Game experience questionnaire	users' game experience	2 years
Primary	Guideline-based qualitative interview	Users' opinions and feedback	2 years
Primary	System usability questionnaire	System usability scale	2 years