Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438432
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-27
Brief Title:
Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
Sponsor:
Union de Gestion des Etablissements des Caisses dAssurance Maladie - Nord Est
Organization:
Union de Gestion des Etablissements des Caisses dAssurance Maladie - Nord Est
Study Overview
Official Title:
Trunk Activity Rehabilitation in Young Children With Cerebral Palsy
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ActivTronc
Brief Summary:
Children with CP exhibit trunk control issues from early childhood affecting their balance and gait These issues manifest as unstable walking increased step width and more pronounced anterior deceleration of the sternum Previous studies have shown that early action of the triceps surae compensates for the deficit in trunk postural control Rehabilitation targeting the trunk has shown significant improvements in postural control and gait
The main objective is to demonstrate that RAIT Rehabilitation by Activities Involving the Trunk significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking with an enhanced effect from prolonged RAIT duration
Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra L5 step width gait variability index and improving scores on the early clinical balance scale and the global motor function evaluation
Participants children with spastic paraparesis or spastic hemiparesis capable of walking independently are divided into two groups one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months RH-RAIT and one group following RAIT for 12 months RAIT-RAIT RH involves rehabilitation exercises for lower limb muscles while RAIT focuses on improving trunk postural control through activities involving intermediate postures
Functional motor assessments will be conducted initially then at 3 6 and 12 months These include clinical evaluations gait analysis step width gait variability index anterior foot support and an analysis of static standing displacement using an inertial sensor placed at L5
At M0 children with CP are expected to show higher values for deceleration peaks and gait variability indices and lower scores on evaluation scales compared to typically developing TD children After RAIT an improvement in judgment criteria is expected reduction in deceleration peaks cycle width gait variability index anterior foot support and an increase in scores on the ECPE and EMFG-66-SI
This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy suggesting that this approach could become a standard rehabilitation practice from early childhood
The main objective is to demonstrate that RAIT Rehabilitation by Activities Involving the Trunk significantly reduces the peak anterior deceleration of the sternum at the beginning of the stance phase during barefoot spontaneous walking with an enhanced effect from prolonged RAIT duration
Secondary objectives include reducing the downward deceleration of the fifth lumbar vertebra L5 step width gait variability index and improving scores on the early clinical balance scale and the global motor function evaluation
Participants children with spastic paraparesis or spastic hemiparesis capable of walking independently are divided into two groups one group continuing their usual rehabilitation for 3 months followed by RAIT for 9 months RH-RAIT and one group following RAIT for 12 months RAIT-RAIT RH involves rehabilitation exercises for lower limb muscles while RAIT focuses on improving trunk postural control through activities involving intermediate postures
Functional motor assessments will be conducted initially then at 3 6 and 12 months These include clinical evaluations gait analysis step width gait variability index anterior foot support and an analysis of static standing displacement using an inertial sensor placed at L5
At M0 children with CP are expected to show higher values for deceleration peaks and gait variability indices and lower scores on evaluation scales compared to typically developing TD children After RAIT an improvement in judgment criteria is expected reduction in deceleration peaks cycle width gait variability index anterior foot support and an increase in scores on the ECPE and EMFG-66-SI
This study aims to confirm that rehabilitation through trunk-involving activities is more effective than usual rehabilitation in improving postural control and gait dynamics in young children with cerebral palsy suggesting that this approach could become a standard rehabilitation practice from early childhood
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None