Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04837105
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2021-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy
Sponsor:
Fondation Ellen Poidatz
Organization:
Study Overview
Official Title:
Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: