NCT07026890

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jul 2025Sep 2027

First Submitted

Initial submission to the registry

June 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

July 16, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

June 10, 2025

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in 'Timed Up and Go' time between initial and final assessment

    5 weeks

Study Arms (2)

Experimental: conventional rehabilitation + 3 virtual reality sessions

EXPERIMENTAL
Other: Evaluation visitsOther: Rehabilitation sessionsOther: Virtual reality sessions

Control: conventional rehabilitation + 3 additional rehabilitation sessions

ACTIVE COMPARATOR
Other: Evaluation visitsOther: Rehabilitation sessionsOther: Additional rehabilitation sessions

Interventions

3 assessment visits (initial (V1), intermediate (V2) and final (V3). A series of motor assessments carried out by the physiotherapist: * Timed Up and Go Test (TUG) * 10 m walk test (TM10) * Functional Reach Test (FRT) * Minimum Motor Test (TMM) * 10 m walk test combined with a verbal task such as naming different animals

Control: conventional rehabilitation + 3 additional rehabilitation sessionsExperimental: conventional rehabilitation + 3 virtual reality sessions

Usual treatment: 4 to 5 rehabilitation sessions per week, each lasting 45 minutes.

Control: conventional rehabilitation + 3 additional rehabilitation sessionsExperimental: conventional rehabilitation + 3 virtual reality sessions

3 virtual reality sessions per week, each lasting 30 minutes.

Experimental: conventional rehabilitation + 3 virtual reality sessions

3 additional rehabilitation sessions per week. These sessions correspond to standard rehabilitation sessions.

Control: conventional rehabilitation + 3 additional rehabilitation sessions

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 18, 2025

Study Start

July 16, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations