An interventional study of Feedback modalities given through an augmented reality headset in Cerebral Palsy, Gait Disorders, Neurologic and Feedback, Psychological, sponsored by Fondation Ellen Poidatz. Completed at 1 site in France. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Fondation Ellen Poidatz · Not applicable, Interventional, and Screening
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 30 is below the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Fondation Ellen Poidatz is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
walking speed
Walking speed recorded with the augmented reality headset in real-time
Time frame: 1 year
step length
step length recorded with the augmented reality headset in real-time
Time frame: 1 year
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
Time frame: 1 year
Plan to share: No
Ran from Jun 2020 to primary completion in Jul 2020, 0 months.
Of 882 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 0 months is below that.
Counting every sponsor, half of 900 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Fondation Ellen Poidatz