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Clinical Trials/NCT04287673
NCT04287673
Completed
Not Applicable

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

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est1 site in 1 country17 target enrollmentDecember 20, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy, Spastic
Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Enrollment
17
Locations
1
Primary Endpoint
Change of the peak of ankle negative power during the weight acceptance phase of gait
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 20, 2016
End Date
November 30, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change of the peak of ankle negative power during the weight acceptance phase of gait

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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)
  • 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)

Study Sites (1)

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