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

NCT04460833 | Completed

• 1 other identifier: BestOf_ARRoW Feedback
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Gait Disorders, Neurologic; Feedback, Psychological

Keywords

Serious Game; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Moizer Questionary

  1 year

Study Arms (1)

Test group

EXPERIMENTAL

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

Device: Feedback modalities given through an augmented reality headset

Interventions

Feedback modalities given through an augmented reality headset 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.

Test group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Medical decision for any reason
• Child or parent decision for any reason
• Inability to cooperate, to understand and to follow instructions

Sponsors & Collaborators

• Fondation Ellen Poidatz: lead
• Université Paris-Sud: collaborator

Study Sites (1)

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, Île-de-France Region, 77310, France

Location

Related Publications (1)

• 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.

  PMID: 35951576 DERIVED

Related Links

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

MeSH Terms

Conditions

Cerebral Palsy; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric DESAILLY, PhD

  Fondation Ellen Poidatz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Feedback modalities are given through an augmented reality headset by random
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: July 8, 2020
• Study Start: June 12, 2020
• Primary Completion: July 7, 2020
• Study Completion: November 26, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)