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

NCT ID: NCT04460833

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-12

Study Completion Date

2021-11-26

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.

Detailed Description

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Conditions

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Cerebral Palsy Gait Disorders, Neurologic Feedback, Psychological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Feedback modalities are given through an augmented reality headset by random

Study Groups

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Test group

All children will have the 6 feedback modalities + the control given randomly

Group Type EXPERIMENTAL

Feedback modalities given through an augmented reality headset

Intervention Type DEVICE

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.

Interventions

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Feedback modalities given through an augmented reality headset

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.

Intervention Type DEVICE

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Paris-Sud

OTHER

Sponsor Role collaborator

Fondation Ellen Poidatz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric DESAILLY, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ellen Poidatz

Locations

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Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, Île-de-France Region, France

Site Status

Countries

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France

References

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Guinet AL, Bouyer G, Otmane S, Desailly E. Visual Feedback in Augmented Reality to Walk at Predefined Speed Cross-Sectional Study Including Children With Cerebral Palsy. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2322-2331. doi: 10.1109/TNSRE.2022.3198243. Epub 2022 Aug 22.

Reference Type DERIVED
PMID: 35951576 (View on PubMed)

Related Links

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https://www.fondationpoidatz.com/

Website of the EllenPoidatz Foundation (See Research and Innovation)

Other Identifiers

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BestOf_ARRoW Feedback

Identifier Type: -

Identifier Source: org_study_id

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