Clinical trial NCT05915130: An Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults
Official title: A Study Protocol for Testing an Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fall
Elderly
Keywords: adaptive behavior
Lead sponsor: Aix Marseille Université
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background Impaired gait adaptability is one of the major causes of falls among older adults by producing inappropriate gait adjustments in cluttered environments. Training programs designed to improve gait adaptability behavior in a systemic approach may prevent falls in older adults. Recently, the technology of virtual reality has appeared as a relevant gait training tool based on its training implementation potential. The present study was designed to compare the effectiveness of a virtual reality gait training program (VR group) for improving gait adaptability behavior and thus, reducing the risk of falls relative to a conventional training program of Nordic walkway (NW group). We hypothesize that the virtual reality gait training program will lead to greater gait adaptability improvements.

Methods The protocol describes a randomized controlled trial with pre-tests, post-tests, retention tests and follow-up. Forty healthy independent living community dweller participants (65-80 years) will be allocated, after a general medical examination, to the VR or the NW group for a training program of six weeks. Primary outcome related to gait adaptability capacities and acceptance of the virtual reality device will be assessed in pre- and post-intervention and one month after the completion of the training program (retention). A follow-up will be done during the 12 months after the completion of the gait training program.

Discussion This study will demonstrate the relative relevance of a gait training program in virtual reality versus a conventional one for improving gait adaptability behavior in healthy older adults and thus preventing falls.


Eligibility criteria: Inclusion Criteria:

* aged between 65 and 80
* with weekly moderate to vigorous physical activity

Exclusion Criteria:

* inability to practice activity at a moderate or vigorous intensity
* moderate or severe cognitive impairments
* severe non-corrected visual impairments
* uncontrolled psychiatric disorders

Primary outcomes:
measure: Gait adaptability capacities
timeFrame: Pre-intervention (week 1)
measure: Gait adaptability capacities
timeFrame: Post-intervention (week 8)
measure: Gait adaptability capacities
timeFrame: Retention (week 12)
measure: Acceptance of the head-mounted device
timeFrame: Pre-intervention (week 1)
measure: Acceptance of the head-mounted device
timeFrame: Post-intervention (week 8)
Secondary outcomes:
measure: Mobility
timeFrame: Pre-intervention (week 1)
measure: Mobility
timeFrame: Post-intervention (week 8)
measure: Mobility
timeFrame: Retention (week 12)
measure: Balance
timeFrame: Pre-intervention (week 1)
measure: Balance
timeFrame: Post-intervention (week 8)
measure: Balance
timeFrame: Retention (week 12)
measure: Motivation
timeFrame: Pre-intervention (week 1)
measure: Motivation
timeFrame: Post-intervention (week 8)
measure: Motivation
timeFrame: Retention (week 12)
measure: Intrinsic motivation
timeFrame: Pre-intervention (week 1)
measure: Intrinsic motivation
timeFrame: Post-intervention (week 8)
measure: Intrinsic motivation
timeFrame: Retention (week 12)
measure: Fear of falling
timeFrame: Pre-intervention (week 1)
measure: Fear of falling
timeFrame: Post-intervention (week 8)
measure: Fear of falling
timeFrame: Retention (week 12)
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institute of Movement Sciences
Study officials:
References: