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

Not Applicable

Completed

• Conditions: Feedback, Psychological; Gait Disorders, Neurologic; Cerebral Palsy
• Interventions: Device: Feedback modalities given through an augmented reality headset

• Registration Number: NCT04460833
• Lead Sponsor: Fondation Ellen Poidatz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study Start: 2020-06-12
• Study First Submitted QC: 2020-07-02
• Primary Completion: 2020-07-07
• Study First Posted: 2020-07-08
• Study Completion: 2021-11-26
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	Feedback modalities given through an augmented reality headset	All children will have the 6 feedback modalities + the control given randomly

Primary Outcome Measures

Name	Time	Method
step length	1 year	step length recorded with the augmented reality headset in real-time
walking speed	1 year	Walking speed recorded with the augmented reality headset in real-time

Secondary Outcome Measures

Name	Time	Method
Moizer Questionary	1 year	User experience survey; 25 items scored 1 for "I perfectly agree" to 5 "I completly disagree" this item; max score = 25; min score = 125

Trial Locations

Locations (1)

Fondation Ellen Poidatz; 🇫🇷 Saint-Fargeau-Ponthierry, ILE DE France, France