Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic
• Interventions: Other: Rehabilitation involving strongly the trunk

• Registration Number: NCT04287673
• Lead Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Brief Summary

Gait abnormalities, which occur in Cerebral Palsy (CP), are characterized usually by a toe-to-floor or a plantar-to-floor initial contact (equinus gait), followed by an early braking of the tibia's forward progression (during ankle dorsiflexion). This causes consequently a trunk deceleration. Moreover, children with CP have difficulties to stabilize the trunk and the head in the space, and that could have impact on gait. If equinus gait is often attributed to the triceps surae spasticity, recent works suggest rather that this early braking of the dorsiflexion could be a motor adaptation to axial postural control difficulties. This thesis project aims firstly to attest that locomotor disorders are related to these difficulties in the stabilization of the axial body segments in children with CP and, secondly, to show that improving the trunk and head postural control with a specific rehabilitation protocol could reduce the early braking of the dorsiflexion and, consequently, the gait abnormalities observed in CP.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-20
• Primary Completion: 2019-02-14
• Study Completion: 2019-11-30
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Gross Motor Function Classification System I or II
• no or minimal contracture of the triceps surae
• presence of soleus spasticity

Exclusion Criteria

• botulinum toxin injections or surgery in the lower limb respectively in the 6 and 12 months preceding the study
• any modification of the physical or orthopaedic therapy within the last two months
• minimal hip flexion above 20° in a clinical examination
• pain in the lower legs when standing or walking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RIST-UR	Rehabilitation involving strongly the trunk	Group having performed the rehabilitation involving strongly the trunk for the first 3 months and then having performed its usual rehabilitation for the last 3 months. Before and after each 3-months period, an evaluation of the postural control of the trunk (using the Trunk Control Measurement Scale and a dynamic posturography on an unstable sitting device) and a clinical gait analysis were performed.
UR-RIST	Rehabilitation involving strongly the trunk	Group having performed its usual rehabilitation for the first 3 months and then having performed the rehabilitation involving strongly the trunk for the last 3 months. Before and after each 3-months period, an evaluation of the postural control of the trunk (using the Trunk Control Measurement Scale and a dynamic posturography on an unstable sitting device) and a clinical gait analysis were performed.

Primary Outcome Measures

Name	Time	Method
Change of the peak of ankle negative power during the weight acceptance phase of gait	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In watts per kg.
Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In m/s²
Change of the score of the Trunk Control Measurement Scale (TCMS)	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	Score from 0 to 58. The higher the score, the better the trunk control.
Change of the center of pressure sway area during unstable sitting posturography	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In mm²
Change of the center of pressure velicoty during unstable sitting posturography	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In mm²/s
Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In m/s²

Secondary Outcome Measures

Name	Time	Method
Change of the Dimensionless walking speed	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	Walking speed normalized to the length of the lower limb
Change of the center of pressure sway area during quiet standing	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In mm²
Change of the dimensionless step width	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	Step width during walking normalized to the width of the pelvis
Change of the center of pressure velicoty during quiet standing	Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation	In mm²/s

Trial Locations

Locations (1)

Institut Régional de Médecine Physique et de Réadaptation; 🇫🇷 Nancy, France