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

NCT ID: NCT07063810

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mixed Reality Rehabilitation

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patient (18 years old or older) with motor disorders related to a deficit in postural stability (mini-BESTest ≤ 25) which may be associated with a deficit in the use of upper limbs and locomotion, consecutive to : 1) either acquired neurological impairments (ischemic or hemorrhagic stroke in sub-acute or chronic phase, head trauma, benign tumor operated on with complete removal, cerebral anoxia) , or 2) a neurodegenerative affection (Parkinson's disease, Multiple Sclerosis).

OR

• Child or teenager patient (6 to 17 years old) with motor disorders related to a deficit in postural stability (mini-BESTest ≤ 25) which may be associated with a deficit in the use of upper limbs and locomotion, consecutive to 1) either spastic, dyskinetic or ataxic cerebral palsy, or 2) a similar impairment without diagnosis or of another etiology.
• Patient able to walk with or without technical aids and to perform voluntary upper limb movements.
• Patient able to understand and follow instructions or adapted communication.
• Patient having given written informed consent concerning his/her participation in the protocol OR (for children) whose parents have given their written informed consent.
• Patient covered by social security.

Exclusion Criteria

• Patient with a severe intellectual disability.
• Patient with a severe attention deficit disorder.
• Patient whose epilepsy is not stable.
• Patient with pain preventing participation in the intended tasks of the protocol.
• Patient with an illness, medical condition or treatment incompatible with participation in the protocol.
• Patient with multiple sclerosis with relapse less than 3 months old.
• Simultaneous participation in other interventional research (1) that may exclude participation in the present study or (2) for which the exclusion period has not ended and whose nature may possibly impact the results of the present research.

In addition, the vulnerable persons mentioned in Articles L. 1121-5, L.1121-6 and L.1121-8 of the French Public Health Code are excluded from the study:

• Pregnant, nursing or parturient women.
• Persons deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
• Adults under legal protection or unable to express their consent.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Caen Normandie

OTHER

Sponsor Role: collaborator

NeoXpériences, Carpiquet, France

UNKNOWN

Sponsor Role: collaborator

Slb Pharma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Continuing care and rehabilitation center (SSR) Les Monts d'Aunay

Aunay-sur-Odon, Normandy, France

Institute of Motor Education (IEM) François Xavier Falala

Hérouville-Saint-Clair, Normandy, France

Physical Medicine and Rehabilitation Center (CMPR) for Children and Adolescents La Clairière

Hérouville-Saint-Clair, Normandy, France

Physical Medicine and Rehabilitation Institute (IMPR) du bois de Lébisey

Hérouville-Saint-Clair, Normandy, France

La Musse Hospital

Saint-Sébastien-de-Morsent, Normandy, France

Countries

France

Central Contacts

Nicolas Benguigui, Professor

Role: CONTACT

nicolas.benguigui@unicaen.fr

+33(0)6.82.28.62.21

Rémi Laillier, Doctor

Role: CONTACT

remi.laillier@unicaen.fr

+33(0)6.62.39.51.14

Facility Contacts

Alexis Ruet, M.D

Role: primary

a.ruet@ch-ab.fr

+33(0)2.31.71.76.51

Anne Fouetillou, M.D

Role: primary

anne.fouetillou-legrigeois@afp.asso.fr

+33(0)2.31.47.36.81

Lionel Billard, M.D

Role: primary

l.billard@normandie-generations.fr

+33(0)2.31.58.32.30

Géraldine Piel, M.D

Role: primary

g.piel@impr-herouville.com

+33(0)2.31.46.36.30

Héloïse Baillet, Ph.D

Role: primary

h.baillet@hlrs-lamusse.net

+33 (0)6.72.91.63.58

Other Identifiers

NEO-REEDUC

Identifier Type: -

Identifier Source: org_study_id