FallNCT05915130
An Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults
A study testing Gait training in people with Fall and Elderly, run by Aix Marseille Université at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Gait training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged between 65 and 80
- with weekly moderate to vigorous physical activity
Who cannot join
- inability to practice activity at a moderate or vigorous intensity
- moderate or severe cognitive impairments
- severe non-corrected visual impairments
- uncontrolled psychiatric disorders
Trial locations and contacts
1 site in 1 country.
France1 site
Institute of Movement Sciences
Marseille, 13288 Marseille cedex 09
Lisa DELBES, PhD, +33 610579276, lisa.delbes@univ-amu.fr
About this study
Official title: A Study Protocol for Testing an Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults
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.
- Being tested
- Gait training
- Keywords
- adaptive behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainingBehavioural
They will negotiate (natural or virtual) obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality training program | Experimental | In the VR group, participants will practice the training sessions in an experimental room. In one training session, participants will negotiate 60 trials. Participants will practice gait training sessions in a fully immersive virtual reality. They will negotiate virtual obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities. Receives: Behavioral: Gait training |
| Nordic walking training program | Experimental | Participants will be instructed to walk with poles continuously around the park. Each training session will consist of a warm-up (10 min), main exercise (40 min), and cool-down (5 min) periods. Participants will adapt their locomotion to uneven terrain. They will negotiate natural obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities. Receives: Behavioral: Gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention (week 1)
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.
Measured: Post-intervention (week 8)
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.
Measured: Retention (week 12)
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)
Measured: Pre-intervention (week 1)
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)
Measured: Post-intervention (week 8)
Secondary outcomes (15)
Mobility
Mobility evaluation will be assessed with the Timed Up-and-Go (TUG) test (performance in s).
Measured: Pre-intervention (week 1)
Mobility
Mobility evaluation will be assessed with the Timed Up-and-Go (TUG) test (performance in s).
Measured: Post-intervention (week 8)
Mobility
Mobility evaluation will be assessed with the Timed Up-and-Go (TUG) test (performance in s).
Measured: Retention (week 12)
Balance
Balance evaluation will be assessed with the Unipedal stance test (performance in s).
Measured: Pre-intervention (week 1)
Balance
Balance evaluation will be assessed with the Unipedal stance test (performance in s).
Measured: Post-intervention (week 8)
Balance
Balance evaluation will be assessed with the Unipedal stance test (performance in s).
Measured: Retention (week 12)
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)
Measured: Pre-intervention (week 1)
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)
Measured: Post-intervention (week 8)
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)
Measured: Retention (week 12)
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)
Measured: Pre-intervention (week 1)
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)
Measured: Post-intervention (week 8)
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)
Measured: Retention (week 12)
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)
Measured: Pre-intervention (week 1)
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)
Measured: Post-intervention (week 8)
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)
Measured: Retention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aix Marseille Université
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Delbes, Aix Marseille Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915130
- Sponsor's protocol ID
- GTPVR
- Status last verified
- Jun 2023
- First submitted
- 23 May 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Protocol for Testing an Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults
- ClinicalTrials.gov ID
- NCT05915130
- Acronym / sponsor ID
- GTPVR
- Keywords
- adaptive behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aix Marseille UniversitéUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality training program | Experimental | Behavioral: Gait trainingIn the VR group, participants will practice the training sessions in an experimental room. In one training session, participants will negotiate 60 trials. Participants will practice gait training sessions in a fully immersive virtual reality. They will negotiate virtual obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities. |
| Nordic walking training program | Experimental | Behavioral: Gait trainingParticipants will be instructed to walk with poles continuously around the park. Each training session will consist of a warm-up (10 min), main exercise (40 min), and cool-down (5 min) periods. Participants will adapt their locomotion to uneven terrain. They will negotiate natural obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged between 65 and 80
- with weekly moderate to vigorous physical activity
Key exclusion criteria (4 listed)
- inability to practice activity at a moderate or vigorous intensity
- moderate or severe cognitive impairments
- severe non-corrected visual impairments
- uncontrolled psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait trainingThey will negotiate (natural or virtual) obstacles such as avoiding a rock or crossing over a tree root, thus improving their gait adaptability capacities. | Behavioural | Nordic walking training program, Virtual reality training program |
Primary outcome
Gait adaptability capacities
Time frame: Pre-intervention (week 1)
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.
Gait adaptability capacities
Time frame: Post-intervention (week 8)
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.
Gait adaptability capacities
Time frame: Retention (week 12)
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.
Acceptance of the head-mounted device
Time frame: Pre-intervention (week 1)
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)
Acceptance of the head-mounted device
Time frame: Post-intervention (week 8)
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)
15 secondary outcomes
Mobility
Time frame: Pre-intervention (week 1)
Mobility
Time frame: Post-intervention (week 8)
Mobility
Time frame: Retention (week 12)
Balance
Time frame: Pre-intervention (week 1)
Balance
Time frame: Post-intervention (week 8)
Balance
Time frame: Retention (week 12)
Motivation
Time frame: Pre-intervention (week 1)
Motivation
Time frame: Post-intervention (week 8)
Motivation
Time frame: Retention (week 12)
Intrinsic motivation
Time frame: Pre-intervention (week 1)
Intrinsic motivation
Time frame: Post-intervention (week 8)
Intrinsic motivation
Time frame: Retention (week 12)
Fear of falling
Time frame: Pre-intervention (week 1)
Fear of falling
Time frame: Post-intervention (week 8)
Fear of falling
Time frame: Retention (week 12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training in people with Fall and Elderly, run by Aix Marseille Université at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait adaptability capacities (time frame: Pre-intervention (week 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.