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NCT Number: NCT04280458

Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on 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.

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Key information

Conditions

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

As secondary objectives, the study aims to:

  • 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.
  • evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.
  • study the concordance between the Vineland scale and the Brunet-Lézine scale.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Intentive rehabilitation

Behavioral

Intervention included:

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

during 12 months.

Routine Care

Behavioral

Intervention included:

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

Primary outcomes

  1. Evolution of adaptative behaviour

    Time frame: At 12 months

    Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.

Secondary outcomes

  1. Evolution of adaptative behaviour

    Time frame: At 6 months

    Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.

  2. Evolution of development

    Time frame: At 12 months

    Brunet-Lézine Scale will be used to evaluate the evolution of development.

  3. 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.

  4. 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.

  5. 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.

  6. Quality of family's life surveys

    Time frame: At baseline and 12 months

    WHOQOL-Bref questionnaire will be used.

  7. 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.

  8. 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.

  9. Clinical Global Impressions by caregivers

    Time frame: At baseline and 12 months

    Clinical Global Impressions (CGI) Scale will be used by caregivers.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Christine ROUSSEAU, MD

CONTACT

[email protected]

+33 (4) 94 38 08 17

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: REEDUC-PLH

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2020
Registry last updated
Mar 19, 2025

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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