Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing fetal or infant brain. The motor disorder of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour; by epilepsy, and by secondary musculoskeletal problems. Motor activities, especially walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide feedback, during gait rehabilitation is a complementary approach to improve motor learning during the rehabilitation protocol. However, the feedback modalities are multiple and no study has compared these modalities. This study aims to test which feedback modalities could control the gait parameters (speed, cadence, step length) of the child with CP in real-time, through an augmented reality environment.

Official Title
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Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)

Conditions
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Cerebral Palsy, Gait Disorders, Neurologic, Feedback, Psychological

Intervention / Treatment
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* Device: Feedback modalities given through an augmented reality headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with Cerebral palsy (medical file) Age 12-18 Global Motor Function Classification System (GMFCS) I-III Functional Mobility Scale (FMS) minimum 2 for 50 meters Ability to cooperate, to understand and to follow instructions Patient affiliated to the French social security system Patient volunteers whose the parents given their authorization to participate Exclusion Criteria: Medical decision for any reason Child or parent decision for any reason Inability to cooperate, to understand and to follow instructions

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>All children will have the 6 feedback modalities + the control given randomly | Device: Feedback modalities given through an augmented reality headset<br>* All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walking speed | Walking speed recorded with the augmented reality headset in real-time | 1 year | 
| step length | step length recorded with the augmented reality headset in real-time | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moizer Questionary | User experience survey; 25 items scored 1 for I perfectly agree to 5 I completly disagree this item; max score = 25; min score = 125 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serious Game, Rehabilitation