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

NCT ID: NCT04287673

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-20

Study Completion Date

2019-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy, Spastic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Rehabilitation involving strongly the trunk

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Rehabilitation involving strongly the trunk

Intervention Type 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.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Beyaert, PU-PH

Role: PRINCIPAL_INVESTIGATOR

University of Lorraine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Régional de Médecine Physique et de Réadaptation

Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRR-2015-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.