NEO-REEDUC - Mixed Reality for Motor Rehabilitation: a Prospective, Multicenter, Controlled, Randomized, Open Study.

Sponsor
Slb Pharma
Study ID
NCT07063810
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mixed Reality Rehabilitation — DEVICE
    The mixed reality protocol will be based on 5 perceptual-motor activities (i.e., games specifically developed for the purposes of this study). The activities consist in walking to collect objects, avoid obstacles, or move the upper limbs to catch virtual balls or fit in narrow shapes. Three games will be performed per session, for a duration of 15 minutes each over 1h sessions with rest times. The level of the activities will be adapted to the performance of the participants during the course of the protocol, by manipulating game settings: necessary speed, accuracy and movement frequency.

Study Details

This study aims to assess the effectiveness of a motor rehabilitation protocol that includes mixed reality activities, compared to conventional rehabilitation, on postural stability in children and adult patients with neurological impairments.

Key Dates

First listed
Jul 14, 2025
Start date
Jul 10, 2025
Status verified
Jun 2025
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mixed Reality Group
    Patients will receive a mixed reality rehabilitation protocol for 4 weeks, on the basis of 3 sessions per week. These sessions will replace up to 3 usual motor rehabilitation sessions in order to limit any major increase in motor solicitations during this period.
  • No Intervention: Control Group
    Patients who will be assigned to the control group will follow their usual care for 4 weeks (usual motor activity, including rehabilitation and sports or physical activities). The rehabilitation protocol will be proposed after the second post-test phase.

Primary Outcome Measure

Change in postural stability measured by the Mini-BesTest (or Kids Mini-BesTest) for children. [ Time Frame: Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14). ]

Central Contacts

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