- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07026890
- Original Trial
The Benefits of Virtual Reality in the Care of Elderly People With Psychomotor Disadaptation Syndrome (VIR-AGE)
The Value of Virtual Reality in the Care of Elderly People With Psychomotor Disadaptation Syndrome: a Randomised Controlled Trial of Mixed Efficacy and Implementation vs. Conventional Rehabilitative Care
Psychomotor Disadaptation Syndrome (PMDS) is characterised by a deterioration in postural function, gait and psychomotor automatisms in the elderly. It is often associated with falls and can manifest itself as retropulsion, gait abnormalities, neurological disorders and psycho-behavioural problems. For the majority of these patients, a stay in a geriatric medical and rehabilitation centre is necessary, enabling an objective assessment of these disorders and multi-professional care, including physiotherapists, occupational therapists and adapted physical activity teachers, aimed at restoring safe movement and motor independence. However, rehabilitation relies on traditional exercises that are limited, repetitive and sometimes far removed from everyday activities. Technological innovations such as virtual reality (VR) offer opportunities to improve care by creating immersive environments that reproduce real-life situations. VR could thus help to rehabilitate the motor problems associated with MS.
The aim of the VIR-AGE project is to study the clinical benefits of VR in the rehabilitation of hospitalised elderly people suffering from PMDS in terms of functional deficits, particularly motor deficits.
The study will take place at the Centre gériatrique Champmaillot of the CHU Dijon Bourgogne. A total of 50 patients with SPDM will take part.
The total duration of your participation is 5 weeks.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul ORNETTI
- Phone Number: 0380293745
- Email: paul.ornetti@chu-dijon.fr
Study Locations
-
-
-
Dijon, France, 21000
- Recruiting
- CHU Dijon Bourgogne
-
Contact:
- Mathieu GUEUGNON
- Phone Number: 0380293571
- Email: mathieu.gueugnon@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Person who has given written consent
- Person aged ≥ 65 years;
- With a proven diagnosis of motor maladjustment syndrome;
- Hospitalised in a geriatric care unit;
- Able to understand a simple instruction and answer a closed question;
- Ability to perform the TUG within 7 days of arriving on site
Exclusion Criteria:
- Person not affiliated to or not benefiting from a social security scheme
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a judicial protection measure
- An adult who is incapable or unable to give consent
- Persons with epilepsy, kinetosis or known claustrophobia Persons unable to understand simple instructions for carrying out tests
- Anyone with a severe visual and/or hearing impairment
- Any person with a behavioural disorder (agitation, aggressiveness)
- Any person with a severe walking or balance problem that makes motor exercises unsuitable
- Anyone with a pathology, injury, wound or severe deformity to the head or cervical spine
- Any person suffering from severe vertigo, diagnosed at the discretion of the investigating doctor
- Inability to use arm for pointing
- Persons susceptible to migraines
- Non-French speakers
- Anyone with an inter-pupillary distance outside the range of possible helmet adjustments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: conventional rehabilitation + 3 virtual reality sessions
|
3 assessment visits (initial (V1), intermediate (V2) and final (V3). A series of motor assessments carried out by the physiotherapist:
Usual treatment: 4 to 5 rehabilitation sessions per week, each lasting 45 minutes.
3 virtual reality sessions per week, each lasting 30 minutes.
|
|
Active Comparator: Control: conventional rehabilitation + 3 additional rehabilitation sessions
|
3 assessment visits (initial (V1), intermediate (V2) and final (V3). A series of motor assessments carried out by the physiotherapist:
Usual treatment: 4 to 5 rehabilitation sessions per week, each lasting 45 minutes.
3 additional rehabilitation sessions per week.
These sessions correspond to standard rehabilitation sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in 'Timed Up and Go' time between initial and final assessment
Time Frame: 5 weeks
|
5 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIPANDA 2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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