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Clinical Trials/NCT06117319
NCT06117319
Completed
Not Applicable

Development and Validation of Sports Facilities in a Supportive Environment to Improve the Well-being of the Elderly

TOPMED1 site in 1 country34 target enrollmentFebruary 27, 2023
ConditionsAging Well

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging Well
Sponsor
TOPMED
Enrollment
34
Locations
1
Primary Endpoint
Learning of Virtual Reality Tasks
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The purpose of this clinical trial is to learn more about the potential for using virtual reality in older adults living in residences for elderly to maintain health (physical activity, cognitive activity, social behaviors). The main questions it aims to answer are:

  • To what extent can virtual reality be a tool to support health in older adults?
  • What are the support needs of older adults in learning to use this immersive technology?

Participants are invited to complete 5 weekly training sessions on the use of a virtual reality headset. At the beginning and end of each session, participants will complete a questionnaire on their perception of their experience. During the sessions, the participants are asked to test games that mobilize the upper limbs. Two learning modalities are set up in two separate groups. These modalities aim to test two different support formulas in order to compare the support needs of the elderly in the use and integration of virtual reality to support the activities and health of this population.

Registry
clinicaltrials.gov
Start Date
February 27, 2023
End Date
April 16, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
TOPMED
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Independent person living in the sponsor's retirement home

Exclusion Criteria

  • Having a pacemaker
  • Being at risk for epilepsy

Outcomes

Primary Outcomes

Learning of Virtual Reality Tasks

Time Frame: During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

Total score on 43 different tasks using a 5 point scale for each task(impossible(0), completion with external help(1), delay before individual completion and multiple repetitions(2), individual completion with less than 2 repetitions(3), individual completion without repetition(4) scored from 0 to 4 respectively). Scores for each session are averaged (Total score range from 0 to 4). Interpretations should be taken with caution(see Analysis population description).

Ease

Time Frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

Measurement of the perception of ease using a one item 5 point scale (higher score means higher ease during the session).Total score range from 1 to 5.

Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5

Time Frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

measurement of the perception of sense of control using a one item 1-5 point scale (higher score means higher sense of control during the session).Total score range from 1 to 5.

Satisfaction With Supervision

Time Frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

measurement of the perception of satisfaction using a one item 5 point scale (higher score means higher satisfaction during the session). Total score range from 1 to 5.

Secondary Outcomes

  • Stress Level at the Start of the Session(Immediately before each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29))
  • Desire to Play Virtual Reality Games(Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29))

Study Sites (1)

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