Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
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• 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)

• Ability to cooperate, understand and follow simple instructions to play.

• Patient affiliated to the French social security system

• Voluntary patient whose parents have given their consent for their child to participate in the study

• Patient who has undergone multisite surgery of the lower limbs including bone procedures at least 7 weeks before the start of the procedure

Locations
Other Locations
France
Fondation Ellen Poidatz
RECRUITING
Saint-fargeau-ponthierry
Time Frame
Start Date: 2021-04-15
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 14
Treatments
Active_comparator: Control group
Classic rehab (physio including strength rehab, fitness, motor activity...) + treadmill gait training 3\*/week/4weeks:~5 minutes of warm-up with gradual increase in treadmill speed, max 20 minutes of walking at 80% of maximum speed, 5 minutes of active recovery with gradual decrease in treadmill speed.~(protocol from Grecco et al.)
Experimental: Test group
Classic rehab - same as control group - (physio including strength rehab, fitness, motor activity...) + overground ARROW CP gait training 3\*/week/4weeks:~walking sprint session at maximal speed with gradual increase in number of repetitions over the weeks.~(protocol from Verschuren et al.)
Related Therapeutic Areas
Sponsors
Leads: Fondation Ellen Poidatz

This content was sourced from clinicaltrials.gov