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

CompletedNot a drug-phase studyMS (type not specified)NCT07063810

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Mixed Reality Rehabilitation

What it measured

Main measures

  • 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).

Other measures (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).

    Walking and mobility
  • 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).

    Walking and mobility
  • 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).

    Walking and mobilityArm and hand function
  • 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).

    Quality of life (reported by participants)
  • 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).

    FatiguePain
  • 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).

    Arm and hand function
  • 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).

  • 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).

Who could take part

MS (type not specified) · 6 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jun 2025

    2. Main results due

      Apr 2026

    3. Finished

      Apr 2026

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