Clinical trial NCT04287673: Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
Official title: Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Keywords: Trunk control
Postural Control
Cerebral Palsy
Rehabilitation
Axial segments
Lead sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 17
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of the peak of ankle negative power during the weight acceptance phase of gait
timeFrame: 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
measure: Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait
timeFrame: 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
measure: Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait
timeFrame: 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
measure: Change of the score of the Trunk Control Measurement Scale (TCMS)
timeFrame: 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
measure: Change of the center of pressure velicoty during unstable sitting posturography
timeFrame: 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
measure: Change of the center of pressure sway area during unstable sitting posturography
timeFrame: 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
Secondary outcomes:
measure: Change of the Dimensionless walking speed
timeFrame: 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
measure: Change of the dimensionless step width
timeFrame: 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
measure: Change of the center of pressure velicoty during quiet standing
timeFrame: 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
measure: Change of the center of pressure sway area during quiet standing
timeFrame: 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
Other outcomes:
Locations:
city: Nancy
country: France
facility: Institut Régional de Médecine Physique et de Réadaptation
Study officials:
affiliation: University of Lorraine
name: Christian Beyaert, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: