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CompletedNCT04287673Updated Jul 3, 2024

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

An interventional study of Rehabilitation involving strongly the trunk in Cerebral Palsy, Spastic, sponsored by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est. Completed at 1 site in France. Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Dec 2016, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy, Spastic

Keywords

  • Trunk control
  • Postural Control
  • Cerebral Palsy
  • Rehabilitation
  • Axial segments
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 134 are open to participants now.

This study's enrollment of 17 is below the median of 30 across 538 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • 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

  • 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

  • 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)

Interventions

  • OtherRehabilitation 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.

06

What researchers measure

Primary outcomes

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

    In watts per kg.

    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

  2. Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait

    In m/s²

    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

  3. Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait

    In m/s²

    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

  4. 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.

    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

  5. Change of the center of pressure velicoty during unstable sitting posturography

    In mm²/s

    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

  6. Change of the center of pressure sway area during unstable sitting posturography

    In mm²

    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

Secondary outcomes

  1. Change of the Dimensionless walking speed

    Walking speed normalized to the length of the lower limb

    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

  2. Change of the dimensionless step width

    Step width during walking normalized to the width of the pelvis

    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

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

    In mm²/s

    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

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

    In mm²

    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

07

Study locations

1 site
  • Institut Régional de Médecine Physique et de Réadaptation
    Nancy, 54000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04287673
Lead sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Responsible party
Sponsor
First posted
Feb 27, 2020
Start date
Dec 20, 2016
Primary completion
Feb 14, 2019
Completion
Nov 30, 2019
Last update
Jul 3, 2024

Study contacts

Christian Beyaert, PU-PH
principal investigator · University of Lorraine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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