Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap (REEDUC-PLH)

March 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap

Primary objective of the study is to compare and evaluate the impact of intensive care of rehabilitation of psychomotor vs. the standard care on adaptive behaviour of children with polyhandicap at 12 months after randomization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As secondary objectives, the study aims to:

  1. compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:

    • result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization;
    • result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization;
    • the pain evaluation at 12 months after randomization;
    • the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization);
    • the quality of life of the patients' family or relatives at 12 months after randomization;
    • the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization.
  2. evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.
  3. study the concordance between the Vineland scale and the Brunet-Lézine scale.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children between 4 and 13 years;

  • With polyhandicap defined by association of the 5 following criteria:

    • Causal brain injury occurred before the age of 3 years
    • Severe or deep mental deficiency as defined by IQ < 40, or no evaluable by the psychometric tests
    • Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders
    • Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V
    • Score of Functional Independence Measure < 50;
  • Hospitalization in a clinical setting participating to the study;
  • Beneficiary of a social protection;
  • Written consent signed by personnel holding parental authority or legal representative.

Exclusion Criteria:

  • Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases;
  • Planned to move in another clinical setting;
  • Foreseeable difficulty in the following up in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
patients will receive intensive care of rehabilitation of psychomotor
Behavioral: Intentive rehabilitation

Intervention included:

  • psychomotor 5 hours/week ±30 minutes
  • kinesitherapy 1.5 hour/week ±20 minutes

during 12 months.
Active Comparator: Control group
patients will receive standard care
Behavioral: Routine care

Intervention included:

  • kinesitherapy 0.5 hour/week ±10 minutes
  • psychomotor 30 min/week ±10 minutes during 12 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evolution of adaptative behaviour
Time Frame: At 12 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
At 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution of adaptative behaviour
Time Frame: At 6 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
At 6 months
Evolution of development
Time Frame: At 12 months
Brunet-Lézine Scale will be used to evaluate the evolution of development.
At 12 months
Pain evaluation
Time Frame: At 12 months
Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.
At 12 months
Durability of acquired cognitive-motor abilities
Time Frame: at 18 months
Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.
at 18 months
Durability of acquired cognitive-motor abilities
Time Frame: at 18 months
The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities.
at 18 months
Quality of family's life surveys
Time Frame: At baseline and 12 months
WHOQOL-Bref questionnaire will be used.
At baseline and 12 months
Emotional distress measurement
Time Frame: At baseline and 12 months
Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents.
At baseline and 12 months
Burden surveys
Time Frame: At baseline and 12 months
Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents.
At baseline and 12 months
Clinical Global Impressions by caregivers
Time Frame: At baseline and 12 months
Clinical Global Impressions (CGI) Scale will be used by caregivers.
At baseline and 12 months
Quality of caregivers' life
Time Frame: At baseline and 12 months
The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers.
At baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Christine ROUSSEAU, MD, Polyhandicap adultes San Salvadour, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP200866
  • 2020-A00800-39 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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