An interventional study of Mixed Reality Rehabilitation in Neurological Conditions, Brain Diseases and Cerebral Palsy, sponsored by Slb Pharma. Completed at 5 sites in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Slb Pharma · Not applicable, Interventional, and Treatment
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.
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.
502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.
This study's enrollment of 76 is above the median of 66 across 339 interventional studies indexed under Brain Diseases.
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- 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
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).
Change in postural stability measured by the Functional Reach Test.
The test measures the maximum amplitude of a forward-reach movement before losing balance (in cm). A higher score means better performance .
Time frame: 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).
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.
Time frame: 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.
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.
Time frame: 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).
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).
Time frame: Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).
Change in pain, fatigue and motivation during the rehabilitation
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.
Time frame: 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).
Change in cinematic parameters of upper limb movements and locomotion during the virtual activities (experimental group only).
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.
Time frame: For each trial of every virtual activity during the rehabilitation phase (weeks 2 to 5).
Progression in difficulty levels of the virtual activities (experimental group only).
The mixed reality activities can be performed in levels ranging from 1 to 10.
Time frame: For each trial of every virtual activity during the rehabilitation phase (weeks 2 to 5).
User experience measures as perceived by the care providers involved in the mixed reality rehabilitation protocol, using the AttrakDiff, UEQ and meCUE questionnaires.
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.
Time frame: At one point during the rehabilitation phase (during week 4 or 5).
Plan to share: No
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