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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Feedback, Psychological
• Intervention / Treatment: Device: Feedback modalities given through an augmented reality headset

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • ILE DE France
    • Saint-Fargeau-Ponthierry, ILE DE France, France, 77310
      • Fondation Ellen Poidatz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Test group; All children will have the 6 feedback modalities + the control given randomly

Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ellen Poidatz
• Collaborators: Université Paris-Sud
• Investigators: Principal Investigator: Eric Desailly, PhD, Fondation Ellen Poidatz

Publications and helpful links

General Publications

• 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.

Helpful Links

• Website of the EllenPoidatz Foundation (See Research and Innovation)

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): November 26, 2021

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Serious Game
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: BestOf_ARRoW Feedback

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No