Psychomotor Disadaptation SyndromeTERV-SDPMNCT06884735
Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome
A study testing exposure to virtual reality in people with Psychomotor Disadaptation Syndrome, run by Hopital Nord Franche-Comte at 1 site in France.
Trial summary
According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Psychomotor Disadaptation Syndrome
- What is being tested?
- exposure to virtual reality
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients diagnosed with PMDS
- Ability to stand without human or technical assistance
- Falls Efficacy Scale International Short (FES-I short) > 13
- Functional Reach Test (FRT) score < 26 cm
- Mini-Mental State Examination (MMSE) score ≥ 20
Who cannot join
- Patients with disorders that may interfere with immersion in virtual reality (e.g. cerebellar syndromes, Parkinsonian syndromes, hallucinations, sensory or neurocognitive disorders)
- Cybermalaise or cyberkinetosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Nord Franche-Comté
Trévenans, 90400
Elodie Bouvier, +33384983570, elodie.bouvier@hnfc.fr
About this study
Official title: Virtual Reality Exposure Therapy (VRET) for Balance in Patients Suffering From Psychomotor Disadaptation Syndrome
According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling.
Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability.
Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.
- Conditions
- Psychomotor Disadaptation Syndrome
- Being tested
- exposure to virtual reality
- Keywords
- Virtual Reality Exposure Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to virtual realityOther
exposure to virtual reality
| Study group | Role | What they receive |
|---|---|---|
| exposure to a previous vacuum | Experimental | exposure to a previous vacuum Receives: Other: exposure to virtual reality |
| museum exposure | Sham comparator | museum exposure Receives: Other: exposure to virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Average velocity variance of the center of pressure (cm/s) measured by a stabilometric measurement platform before, immediately after, then post-24h exposure to VR
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychomotor Disadaptation SyndromeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884735
- Sponsor's protocol ID
- 2024-03-TERV-SDPM
- Acronym
- TERV-SDPM
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy (VRET) for Balance in Patients Suffering From Psychomotor Disadaptation Syndrome
- ClinicalTrials.gov ID
- NCT06884735
- Acronym / sponsor ID
- TERV-SDPM / 2024-03-TERV-SDPM
- Conditions
- Psychomotor Disadaptation Syndrome
- Keywords
- Virtual Reality Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 19 Mar 2025 (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.
According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling.
Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability.
Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure to a previous vacuum | Experimental | Other: exposure to virtual realityexposure to a previous vacuum |
| museum exposure | Sham comparator | Other: exposure to virtual realitymuseum exposure |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with PMDS
- Ability to stand without human or technical assistance
- Falls Efficacy Scale International Short (FES-I short) > 13
- Functional Reach Test (FRT) score < 26 cm
- Mini-Mental State Examination (MMSE) score ≥ 20
Key exclusion criteria (2 listed)
- Patients with disorders that may interfere with immersion in virtual reality (e.g. cerebellar syndromes, Parkinsonian syndromes, hallucinations, sensory or neurocognitive disorders)
- Cybermalaise or cyberkinetosis
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 |
|---|---|---|
| exposure to virtual realityexposure to virtual reality | Other | exposure to a previous vacuum, museum exposure |
Primary outcome
Balance
Time frame: Day 1
Average velocity variance of the center of pressure (cm/s) measured by a stabilometric measurement platform before, immediately after, then post-24h exposure to VR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Psychomotor Disadaptation Syndrome
Recruiting
The Benefits of Virtual Reality in the Care of Elderly People With Psychomotor Disadaptation Syndrome
Psychomotor Disadaptation Syndrome
Not yet recruiting
Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome in Elderly Persons
Psychomotor Disadaptation Syndrome, Post-fall Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exposure to virtual reality in people with Psychomotor Disadaptation Syndrome, run by Hopital Nord Franche-Comte 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Balance (time frame: Day 1). 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 25 Feb 2026.