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

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: Recruiting
• Conditions: Polyhandicap
• Intervention / Treatment: Behavioral: Intentive rehabilitation; Behavioral: Routine care

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: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Christine ROUSSEAU, MD; Phone Number: +33 (4) 94 38 08 17; Email: marie-Christine.rousseau@aphp.fr

Study Locations

• France
  • Var
    • Hyères, Var, France, 83407
      • Recruiting
      • Hôpital San Salvadour
      • Contact: Marie-Christine ROUSSEAU, MD; Phone Number: + 33 6 70 90 30 90; Email: marie-christine.rousseau@aphp.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Evolution of adaptative behaviour	Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of adaptative behaviour	Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.	At 6 months
Evolution of development	Brunet-Lézine Scale will be used to evaluate the evolution of development.	At 12 months
Pain evaluation	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	Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.	at 18 months
Durability of acquired cognitive-motor abilities	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	WHOQOL-Bref questionnaire will be used.	At baseline and 12 months
Emotional distress measurement	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	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	Clinical Global Impressions (CGI) Scale will be used by caregivers.	At baseline and 12 months
Quality of caregivers' life	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

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Marie-Christine ROUSSEAU, MD, Polyhandicap adultes San Salvadour, APHP

Publications and helpful links

General Publications

• Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
• Collignon P, Giusiano B. Validation of a pain evaluation scale for patients with severe cerebral palsy. Eur J Pain. 2001;5(4):433-42. doi: 10.1053/eujp.2001.0265.
• Laor-Maayany R, Goldzweig G, Hasson-Ohayon I, Bar-Sela G, Engler-Gross A, Braun M. Compassion fatigue among oncologists: the role of grief, sense of failure, and exposure to suffering and death. Support Care Cancer. 2020 Apr;28(4):2025-2031. doi: 10.1007/s00520-019-05009-3. Epub 2019 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; psychomotor; children polyhandicap; cognitive-motor; adaptative skill
• Other Study ID 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