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

Primary Purpose

Cerebral Palsy, Gait Disorders, Neurologic, Feedback, Psychological

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Feedback modalities given through an augmented reality headset
Sponsored by
Fondation Ellen Poidatz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cerebral Palsy focused on measuring Serious Game, Rehabilitation

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Ellen Poidatz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Test group

Arm Description

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

Outcomes

Primary Outcome Measures

walking speed
Walking speed recorded with the augmented reality headset in real-time
step length
step length recorded with the augmented reality headset in real-time

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2020
Last Updated
June 22, 2022
Sponsor
Fondation Ellen Poidatz
Collaborators
Université Paris-Sud
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1. Study Identification

Unique Protocol Identification Number
NCT04460833
Brief Title
Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy
Acronym
BestOf_ARRoW
Official Title
Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
July 7, 2020 (Actual)
Study Completion Date
November 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ellen Poidatz
Collaborators
Université Paris-Sud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Gait Disorders, Neurologic, Feedback, Psychological
Keywords
Serious Game, Rehabilitation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Feedback modalities are given through an augmented reality headset by random
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
All children will have the 6 feedback modalities + the control given randomly
Intervention Type
Device
Intervention Name(s)
Feedback modalities given through an augmented reality headset
Intervention Description
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.
Primary Outcome Measure Information:
Title
walking speed
Description
Walking speed recorded with the augmented reality headset in real-time
Time Frame
1 year
Title
step length
Description
step length recorded with the augmented reality headset in real-time
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Moizer Questionary
Description
User experience survey; 25 items scored 1 for "I perfectly agree" to 5 "I completly disagree" this item; max score = 25; min score = 125
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric DESAILLY, PhD
Organizational Affiliation
Fondation Ellen Poidatz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Ellen Poidatz
City
Saint-Fargeau-Ponthierry
State/Province
ILE DE France
ZIP/Postal Code
77310
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35951576
Citation
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.
Results Reference
derived
Links:
URL
https://www.fondationpoidatz.com/
Description
Website of the EllenPoidatz Foundation (See Research and Innovation)

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

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