Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04837105

Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
14 (estimated)
Sponsor
Fondation Ellen Poidatz · Academic / Other
Sex
All
Age
10 Years – 18 Years
Healthy volunteers
Not accepted

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.

Detailed description

This study is a randomized control trial. Participants are children with cerebral palsy having a single event multi level surgery. They are involving in a rehabilitation protocol in the same rehab center. Two groups are formed: * control group: classic rehab+children have treadmill gait protocol during 4 weeks * test group : classic rehab+children have gait training with the ARROW CP serious game. ARROW CP game is developed for augmented reality headset (Microsoft Hololens). It delivers feedback in real time and with delay on participant gait performance. This game has been developed by researchers (Fondation Ellen Poidatz, France). The aims of this study are: 1. . To determine the impact on spatiotemporal gait parameters of intensive gait rehabilitation involving the use of a serious AR game in children and adolescents with cerebral palsy. 2. To explore the effects of playing a serious game on functional abilities 3. To assess motivation, satisfaction and adherence to treatment

Conditions

Interventions

TypeNameDescription
OTHERSerious game ARROW CPARROW 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".
OTHERTreadmillParticipant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down)

Timeline

Start date
2021-04-15
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2021-04-08
Last updated
2025-08-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04837105. Inclusion in this directory is not an endorsement.