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

NCT07063810 | Not Yet Recruiting

• 1 other identifier: NEO-REEDUC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

Mixed Reality; Neurological Conditions; Motor Rehabilitation; Postural Stability; Upper Limb; Locomotion

Outcome Measures

Primary Outcomes (1)

• Change in postural stability measured by the Mini-BesTest (or Kids Mini-BesTest) for children.

  The test measures 5 aspects of postural stability in static and dynamic configurations over 14 items. Scores range from 0 to 28. A higher score indicates an overall better postural stability.

  Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).

Secondary Outcomes (8)

• Change in postural stability measured by the Functional Reach Test.

  Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).

• Change in locomotor ability measured by the 6-minute walk test (6MWT) and the 10-meter walk test (10MWT).

  Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).

• Change in limb mobility measured by goniometry and a specific task implemented in the Mixed reality system.

  Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).

• Change in quality of life measured by the MHAVIE questionnaire (measure of life habits).

  Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).

• Change in pain, fatigue and motivation during the rehabilitation

  Once at the beginning of the rehabilitation period (week 2) and once at the end of each week until the end of this period (weeks 2 to 5).

Study Arms (2)

Mixed Reality Group

EXPERIMENTAL

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.

Device: Mixed Reality Rehabilitation

Control Group

NO INTERVENTION

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.

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.

Mixed Reality Group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Slb Pharma: lead
• Université de Caen Normandie: collaborator
• NeoXpériences, Carpiquet, France: collaborator

Study Sites (5)

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

Aunay-sur-Odon, Normandy, 14260, France

Location

Institute of Motor Education (IEM) François Xavier Falala

Hérouville-Saint-Clair, Normandy, 14200, France

Location

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

Hérouville-Saint-Clair, Normandy, 14200, France

Location

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

Hérouville-Saint-Clair, Normandy, 14200, France

Location

La Musse Hospital

Saint-Sébastien-de-Morsent, Normandy, 27180, France

Location

MeSH Terms

Conditions

Brain Diseases; Cerebral Palsy; Parkinson Disease; Multiple Sclerosis; Craniocerebral Trauma; Ischemic Stroke; Hypoxia, Brain

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Trauma, Nervous System; Wounds and Injuries; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas Benguigui, Professor

CONTACT

+33(0)6.82.28.62.21; nicolas.benguigui@unicaen.fr

Rémi Laillier, Doctor

CONTACT

+33(0)6.62.39.51.14; remi.laillier@unicaen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The care providers will perform the 4-week rehabilitation program for the experimental group. The outcome assessors will only be in charge of the pre and post-test phases, and will not be informed on which group each participant was assigned to. All participants will receive a pseudonym which provides no information on their respective group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter randomized controlled trial will be implemented across five different locations. One hundred and twenty patients will be randomly divided into an experimental group that will follow a mixed reality rehabilitation protocol with a pre-test and two post-test phases, with three weekly sessions for four weeks. A control group will only carry out the pre- and post-tests, and will perform their usual motor rehabilitation program.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 14, 2025
• Study Start: July 10, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)