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OpenTrials
Completed

NCT Number: NCT04287673

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

Secondary outcomes

  1. Change of the Dimensionless walking speed

    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

    Walking speed normalized to the length of the lower limb

  2. Change of the dimensionless step width

    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

    Step width during walking normalized to the width of the pelvis

  3. Change of the center of pressure velicoty during quiet standing

    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

  4. Change of the center of pressure sway area during quiet standing

    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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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