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OpenTrials
Completed

NCT Number: NCT04460833

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ellen Poidatz

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. walking speed

    Time frame: 1 year

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

  2. step length

    Time frame: 1 year

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

Secondary outcomes

  1. Moizer Questionary

    Time frame: 1 year

    User experience survey; 25 items scored 1 for "I perfectly agree" to 5 "I completly disagree" this item; max score = 25; min score = 125

Sponsors and collaborators

Lead sponsor

Fondation Ellen Poidatz

Other

Collaborators

  • Université Paris-Sud

Registry information

Official study title

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

Acronym: BestOf_ARRoW

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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