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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Rehabilitation involving strongly the trunk

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIST-UR; 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.	Other: Rehabilitation involving strongly the trunk; The Rehabilitation involving strongly the trunk (RIST) leaded by a physiotherapist was based on exercises in different postures performed by the child each day that strongly involve the trunk to cope with balance.
Experimental: UR-RIST; 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.	Other: Rehabilitation involving strongly the trunk; The Rehabilitation involving strongly the trunk (RIST) leaded by a physiotherapist was based on exercises in different postures performed by the child each day that strongly involve the trunk to cope with balance.
No Intervention: Typically Developing children; Typically developing children who served as a control group in the first assessment (Trunk Control Measurement Scale, dynamic posturography on an unstable sitting device, clinical gait analysis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the peak of ankle negative power during the weight acceptance phase of gait	In watts per kg.	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 peak of trunk's anterior deceleration during the weight acceptance phase of gait	In m/s²	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 peak of the center of mass downward deceleration during the weight acceptance phase of gait	In m/s²	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 score of the Trunk Control Measurement Scale (TCMS)	Score from 0 to 58. The higher the score, the better the trunk control.	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 unstable sitting posturography	In mm²/s	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 unstable sitting posturography	In mm²	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Dimensionless walking speed	Walking speed normalized to the length of the lower limb	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	Step width during walking normalized to the width of the pelvis	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	In mm²/s	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	In mm²	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

Collaborators and Investigators

• Sponsor: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Investigators: Principal Investigator: Christian Beyaert, PU-PH, University of Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2016
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Cerebral Palsy; Trunk control; Postural Control; Axial segments
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: IRR-2015-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No