An Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults

Elderly Clinical Trial

Official title:

A Study Protocol for Testing an Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05915130
• Other study ID #: GTPVR
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: June 2023
• Source: Aix Marseille Université
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Fall

Intervention

Behavioral:
• Gait training
They will negotiate (natural or virtual) obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities.

Locations

Country	Name	City	State
France	Institute of Movement Sciences	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Aix Marseille Université

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait adaptability capacities	Gait adaptability capacities will be assessed by a specific gait test created to assess gait parameters during goal-directed tasks. Feet positions will be measured by a seven-meter-long portable pressure-sensitive walkway GaitRite® (CIR Systems, Inc., Franklyn, NY, USA) in the real world. Firstly, participants will be instructed to walk at a normal pace on the walkway. The average preferred gait speed, step length, and step duration (with their variabilities) will be calculated over 6 trials. Afterwards, physical obstacles will be placed on the walkway. Participants will perform 3 different locomotor tasks: simple locomotor pointing, crossing-over, and stepping-over tasks (see Figure 4). They will perform 10 trials of each goal-directed task. By recording successive feet positions in relation to the obstacles, gait adaptability behavior will be analyzed through performance, inter-trials and trial-by-trial analyses.	Pre-intervention (week 1)
Primary	Gait adaptability capacities	Gait adaptability capacities will be assessed by a specific gait test created to assess gait parameters during goal-directed tasks. Feet positions will be measured by a seven-meter-long portable pressure-sensitive walkway GaitRite® (CIR Systems, Inc., Franklyn, NY, USA) in the real world. Firstly, participants will be instructed to walk at a normal pace on the walkway. The average preferred gait speed, step length, and step duration (with their variabilities) will be calculated over 6 trials. Afterwards, physical obstacles will be placed on the walkway. Participants will perform 3 different locomotor tasks: simple locomotor pointing, crossing-over, and stepping-over tasks (see Figure 4). They will perform 10 trials of each goal-directed task. By recording successive feet positions in relation to the obstacles, gait adaptability behavior will be analyzed through performance, inter-trials and trial-by-trial analyses.	Post-intervention (week 8)
Primary	Gait adaptability capacities	Gait adaptability capacities will be assessed by a specific gait test created to assess gait parameters during goal-directed tasks. Feet positions will be measured by a seven-meter-long portable pressure-sensitive walkway GaitRite® (CIR Systems, Inc., Franklyn, NY, USA) in the real world. Firstly, participants will be instructed to walk at a normal pace on the walkway. The average preferred gait speed, step length, and step duration (with their variabilities) will be calculated over 6 trials. Afterwards, physical obstacles will be placed on the walkway. Participants will perform 3 different locomotor tasks: simple locomotor pointing, crossing-over, and stepping-over tasks (see Figure 4). They will perform 10 trials of each goal-directed task. By recording successive feet positions in relation to the obstacles, gait adaptability behavior will be analyzed through performance, inter-trials and trial-by-trial analyses.	Retention (week 12)
Primary	Acceptance of the head-mounted device	For the VR group only, VR-HMD acceptance before and after use will be assessed using the Technology Acceptance Model. According to this model, intention to use a technology is positively predicted by its perceived usefulness and its perceived ease of use. VR-HMD acceptance will be assessed through four variables: perceived usefulness, perceived ease of use, perceived enjoyment, and intention to use.; (12 items with a 1-10 Likert scale; a higher score means a better outcome)	Pre-intervention (week 1)
Primary	Acceptance of the head-mounted device	For the VR group only, VR-HMD acceptance before and after use will be assessed using the Technology Acceptance Model. According to this model, intention to use a technology is positively predicted by its perceived usefulness and its perceived ease of use. VR-HMD acceptance will be assessed through four variables: perceived usefulness, perceived ease of use, perceived enjoyment, and intention to use.; (12 items with a 1-10 Likert scale; a higher score means a better outcome)	Post-intervention (week 8)
Secondary	Mobility	Mobility evaluation will be assessed with the Timed Up-and-Go (TUG) test (performance in s).	Pre-intervention (week 1)
Secondary	Mobility	Mobility evaluation will be assessed with the Timed Up-and-Go (TUG) test (performance in s).	Post-intervention (week 8)
Secondary	Mobility	Mobility evaluation will be assessed with the Timed Up-and-Go (TUG) test (performance in s).	Retention (week 12)
Secondary	Balance	Balance evaluation will be assessed with the Unipedal stance test (performance in s).	Pre-intervention (week 1)
Secondary	Balance	Balance evaluation will be assessed with the Unipedal stance test (performance in s).	Post-intervention (week 8)
Secondary	Balance	Balance evaluation will be assessed with the Unipedal stance test (performance in s).	Retention (week 12)
Secondary	Motivation	Motivation for physical activity will be assessed using the ÉMAPS questionnaire recently validated in French (18 items with a 1-7 Likert scale; a higher score means a better outcome)	Pre-intervention (week 1)
Secondary	Motivation	Motivation for physical activity will be assessed using the ÉMAPS questionnaire recently validated in French (18 items with a 1-7 Likert scale; a higher score means a better outcome)	Post-intervention (week 8)
Secondary	Motivation	Motivation for physical activity will be assessed using the ÉMAPS questionnaire recently validated in French (18 items with a 1-7 Likert scale; a higher score means a better outcome)	Retention (week 12)
Secondary	Intrinsic motivation	Intrinsic motivation will be assessed using the Inventory Motivation inventory (IMI) questionnaire (22 items with a 1-7 Likert scale; a higher score means a better outcome)	Pre-intervention (week 1)
Secondary	Intrinsic motivation	Intrinsic motivation will be assessed using the Inventory Motivation inventory (IMI) questionnaire (18 items with a 1-7 Likert scale; a higher score means a better outcome)	Post-intervention (week 8)
Secondary	Intrinsic motivation	Intrinsic motivation will be assessed using the Inventory Motivation inventory (IMI) questionnaire (18 items with a 1-7 Likert scale; a higher score means a better outcome)	Retention (week 12)
Secondary	Fear of falling	Fear of falling will be assessed using the French version of the Modified-Falls Efficacy Scale (14 items with a 1-10 Likert scale; a higher score means a worse outcome)	Pre-intervention (week 1)
Secondary	Fear of falling	Fear of falling will be assessed using the French version of the Modified-Falls Efficacy Scale (14 items with a 1-10 Likert scale; a higher score means a worse outcome)	Post-intervention (week 8)
Secondary	Fear of falling	Fear of falling will be assessed using the French version of the Modified-Falls Efficacy Scale (14 items with a 1-10 Likert scale; a higher score means a worse outcome)	Retention (week 12)