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

NCT04287673 | Completed

• 1 other identifier: IRR-2015-1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy, Spastic

Keywords

Trunk control; Postural Control; Cerebral Palsy; Rehabilitation; Axial segments

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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 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

• 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

Study Arms (3)

RIST-UR

EXPERIMENTAL

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

UR-RIST

EXPERIMENTAL

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

Typically Developing children

NO INTERVENTION

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)

Interventions

Rehabilitation involving strongly the trunk OTHER

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.

RIST-UR; UR-RIST

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est: lead

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christian Beyaert, PU-PH

  University of Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 27, 2020
• Study Start: December 20, 2016
• Primary Completion: February 14, 2019
• Study Completion: November 30, 2019
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

FR (1)