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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07063810
• Lead Sponsor: Slb Pharma

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study Start: 2025-07-10
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).	The test measures the maximum amplitude of a forward-reach movement before losing balance (in cm). A higher score means better performance .
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).	The 6MWT measures the distance covered during a 6-minute period at a normal speed (in meters). The 10MWT measures the time (in seconds) taken to walk 10 meters at a fast speed.
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).	Goniometry measures will be performed in an active rather than passive mode, in a standing position. The amplitude (in °deg) between a neutral position and the maximum movement will be measured on both shoulders, elbows, hips, knees and ankles when possible. The amplitude between a neutral station.; The Mixed reality limb mobility task consists of 4 movements for each upper limb, and 3 movements for each lower limb, covering all dimensions. Joint amplitudes in °deg and percentage of maximum amplitude will be measured. Stride lengths front, back and sideways will also be computed during this task for each leg.
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).	The MHAVIE is a standard quality of life questionnaire validated in French-speaking populations. Participants (with or without help) indicate whether they are able to perform specific actions and if so, if they need technical or human help, as well as their level of satisfaction regarding their ability In the context of this study, 5 dimensions will be considered : locomotion, physical condition and psychological well-being, home, interpersonal relationships and leisure (total : 44 items maximum).
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).	Pain will be measured using the faces pain scale -revised, which is an illustrated 10-point scale.; Fatigue will be measured by a 10-point Likert scale. Motivation will be measured using the Intrinsic motivation inventory. 12 questions will be asked, which patients will answer by rating on scales ranging from 1 to 7.
Change in cinematic parameters of upper limb movements and locomotion during the virtual activities (experimental group only).	For each trial of every virtual activity during the rehabilitation phase (weeks 2 to 5).	Cinematic parameters of movements will be computed thanks to body tracking data recorded by the mixed reality device.Movement speed of the limbs and center of mass, as well as joint amplitudes during each trial of the virtual activities will be measured. The mixed reality activities can be performed in levels ranging from 1 to 10.
Progression in difficulty levels of the virtual activities (experimental group only).	For each trial of every virtual activity during the rehabilitation phase (weeks 2 to 5).	The mixed reality activities can be performed in levels ranging from 1 to 10.
User experience measures as perceived by the care providers involved in the mixed reality rehabilitation protocol, using the AttrakDiff, UEQ and meCUE questionnaires.	At one point during the rehabilitation phase (during week 4 or 5).	The AttrakDiff is a 28-item questionnaire. The care providers will rate the mixed reality system on 7-point scales delimited by pairs of opposite words. Measured dimensions are related to the pragmatic and hedonic quality of the system.; the UEQ follows the same structure as the AttrakDiff and contains 26 items. The measured dimensions are attractiveness, perspicuity, efficiency, dependability, stimulation and novelty.; The meCUE is a 30-item questionnaire (in its French version) questioning the several dimensions regarding the perception of the system, the positive and negative emotions during its use, and its consequences for future use intentions. Each item (except 1) is a 7-point Likert scale. The last item is a general appreciation of the system, on a 11-point scale ranging from -5 to +5.

Trial Locations

Locations (5)

Continuing care and rehabilitation center (SSR) Les Monts d'Aunay; 🇫🇷 Aunay-sur-Odon, Normandie, France

Institute of Motor Education (IEM) François Xavier Falala; 🇫🇷 Hérouville-Saint-Clair, Normandie, France

Physical Medicine and Rehabilitation Center (CMPR) for Children and Adolescents La Clairière; 🇫🇷 Hérouville-Saint-Clair, Normandie, France

Physical Medicine and Rehabilitation Institute (IMPR) du bois de Lébisey; 🇫🇷 Hérouville-Saint-Clair, Normandie, France

La Musse Hospital; 🇫🇷 Saint-Sébastien-de-Morsent, Normandie, France