NCT07063810

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Slb Pharma · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Conventional motor rehabilitation techniques applied to postural stability, locomotion or the upper limbs suffer from certain limitations. Studies in this field have highlighted the length and repetitiveness of these programs, which can lead to patient fatigue and pain. Combined with the lack of recreation and ecology in conventional therapies, which are often decontextualized and highly simplified, all these factors contribute to the lack of transposition of the improvements obtained into daily life activities (DLAs). For several years now, the use of virtual reality (VR) and mixed reality (MR) have emerged as one of the most interesting solutions for overcoming these limitations. These technologies enable patients to take part in rehabilitation protocols under more controlled, progressive and attractive conditions, encouraging better patient adherence. These aspects guarantee effective rehabilitation and generalization of benefits to DLAs. In addition, they involve visuomotor coordination (skills involving the coordination of movements of different body segments with visual information previously perceived during execution), which is a cognitive ability widely transposable to DLAs. Although some previous studies have investigated the effects of VR for motor rehabilitation, this technology also presents practical limitations related to the discomfort induced by the head-mounted displays (cybersickness, and physical discomforts caused by the weight of the display). Moreover, the use of VR tends to isolate the patient from their environment and therefore limits interaction with practitioners. Nevertheless, findings have shown the benefits of a VR protocol applied to motor rehabilitation in children and teenagers with cerebral palsy. The accuracy precision and fluidity of upper limb movements was improved, and the adherence to the protocol was strong. In the line of these findings, the present protocol has several objectives: (1) to use MR, which seems to offer more possibilities while avoiding the disadvantages associated with VR, (2) to extend the applications of the proposed virtual rehabilitation tasks to other major motor functions - postural stability and locomotion as additional targets - and (3) to deploy these new rehabilitation methods to other patients likely to benefit from them (i.e. those with a functional disorder of neurological origin affecting their motor skills). This study will include 120 patients with motor deficiencies of neurological origin, who will be randomly divided into two groups: one group receiving three weekly mixed reality rehabilitation sessions for four weeks, and a control group only following its usual care in the same period. Participants will be randomly matched for pathology, postural stability scores, age and sex. The effectiveness of the rehabilitation protocol will be evaluated through several clinical indicators of postural stability, locomotion and limb mobility as well as psychometrical measurements of fatigue, pain, motivation and quality of life.

Conditions

• Neurological Conditions
• Brain Diseases
• Cerebral Palsy
• Parkinson Disease (PD)
• Multiple Sclerosis
• Head Trauma
• Ischemic Stroke
• Cerebral Anoxia

Interventions

Type	Name	Description
DEVICE	Mixed Reality Rehabilitation	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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2025-07-14
• Last updated: 2025-07-14

Locations

5 sites across 1 country: France