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

Cerebral Palsy Clinical Trial

— BestOf_ARRoW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460833
• Other study ID #: BestOf_ARRoW Feedback
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: June 2022
• Source: Fondation Ellen Poidatz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 26, 2021
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Feedback, Psychological
• Gait Disorders, Neurologic
• Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Fondation Ellen Poidatz	Saint-Fargeau-Ponthierry	ILE DE France

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ellen Poidatz	Université Paris-Sud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking speed	Walking speed recorded with the augmented reality headset in real-time	1 year
Primary	step length	step length recorded with the augmented reality headset in real-time	1 year
Secondary	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

External Links

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