Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorFondation Ellen Poidatz
About this trial
Cerebral palsy (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Motor activities, and in particular walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity. Theories of gait training guide rehabilitation management strategies. Among these, intensification, variability and specific training of walking parameters (speed, step length, cadence) have shown their effectiveness. Delivering sensory feedback during gait rehabilitation exercises is a complementary approach to improve motor learning during rehabilitation. On the other hand, motivation is a key factor in the success of rehabilitation. The addition of walking exercises performed through a serious game in augmented reality (AR) appears relevant for the rehabilitation of children with CP after surgery.
The serious game ARRoW-CP is based on the latest advances in the literature in terms of gait rehabilitation protocol but also on the results of a clinical study conducted by our team, to identify the best feedback modalities to be delivered during the serious rehabilitation game.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A clinical diagnosis of CP mentioned in the medical record
Minor child for the entire duration of the protocol, i.e. between 10 and 17 years of age (the child must be less than 18 years of age at the time of the last check-up scheduled 1 year after inclusion in the study)
Global Motor Function Classification System (GMFCS) levels I to III
Functional Mobility Scale 50 meters rating superior or equal to 2 (ability to walk on 50m using a walker or frame without help from another person)
Disqualifiers
A diagnosis of photosensitive epilepsy mentioned in the medical file AND/OR a mention in the child's medical file or by the parents or by the child of a history of epileptic seizures occurring during the practice of a video game
A visual, cognitive or auditory impairment at a level that would interfere with playing the game. The patient must have normal or corrected vision and hearing.
Trial design
Design model
Parallel
Treatments tested in this trial
Serious game ARROW CP
Other interventionARROW CP is developed for Microsoft Hololens headset. Feedback on gait performance are delivering to the participant in real time and with delay. Participants have to walk at their maximal speed during "sprint session".
Treadmill
Other interventionParticipant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down)
Treatment groups
14 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Test groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
6 minutes walking test
Aim of the measurement: To quantify changes in the parameters of walking quality (speed, cadence, step length). Procedure: The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.
Time frame
6 minutesSecondary outcomes
1
Muscle power sprint test
Aim of the measurement: To assess the anaerobic capacity of children with motor disabilities. Procedure: The patient is asked to perform six 15-metre walking sprints, with 10 seconds of rest between each sprint. The average and maximum power are calculated based on the speeds achieved during the sprints.
Time frame
10 minutes2
Shuttle run test I and II (adapted for children with CP)
In this test, the child must walk between 2 poles spaced 10 metres apart following the "beep rhythm" imposed by a pre-recorded soundtrack. The soundtrack includes an increase in walking speed of 0.25 km/h every minute. (Verschuren et al.)
Time frame
20 minutes3
Questionnaire (PACES)
To assess enjoyment for both control and test group, the 16-items of the Physical Activity Enjoyment Scale (PACES) will be used. The PACES is a valid and re- liable measure of physical activity enjoyment. It has been used in many studies assessing the effectiveness of VR therapy This questionnaire will be presented to the participant at the end of the last session.
Time frame
10 minutesSponsors and contacts
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Source ClinicalTrials.gov