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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorSlb Pharma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Mixed Reality GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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).
2

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).
3

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).
4

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).

Other outcomes

Sponsors and contacts

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Slb Pharma

Lead sponsor

Université de Caen Normandie

Collaborator

NeoXpériences, Carpiquet, France

Collaborator

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