Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap

Polyhandicap Clinical Trial

— REEDUC-PLH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04280458
• Other study ID #: APHP200866
• Secondary ID: 2020-A00800-39
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie-Christine ROUSSEAU, MD
• Phone: +33 (4) 94 38 08 17
• Email: marie-Christine.rousseau[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polyhandicap

Intervention

Behavioral:
• Intentive rehabilitation
Intervention included: psychomotor 5 hours/week ±30 minutes kinesitherapy 1.5 hour/week ±20 minutes during 12 months.
• Routine care
Intervention included: kinesitherapy 0.5 hour/week ±10 minutes psychomotor 30 min/week ±10 minutes during 12 months.

Locations

Country	Name	City	State
France	Hôpital San Salvadour	Hyères	Var

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of adaptative behaviour	Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.	At 12 months
Secondary	Evolution of adaptative behaviour	Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.	At 6 months
Secondary	Evolution of development	Brunet-Lézine Scale will be used to evaluate the evolution of development.	At 12 months
Secondary	Pain evaluation	Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.	At 12 months
Secondary	Durability of acquired cognitive-motor abilities	Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.	at 18 months
Secondary	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
Secondary	Quality of family's life surveys	WHOQOL-Bref questionnaire will be used.	At baseline and 12 months
Secondary	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
Secondary	Burden surveys	Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents.	At baseline and 12 months
Secondary	Clinical Global Impressions by caregivers	Clinical Global Impressions (CGI) Scale will be used by caregivers.	At baseline and 12 months
Secondary	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