NCT04280458

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
2.3 years until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

3.5 years

First QC Date

February 17, 2020

Last Update Submit

March 17, 2025

Conditions

Polyhandicap

Keywords

children polyhandicaprehabilitationpsychomotorcognitive-motoradaptative skill

Outcome Measures

Primary Outcomes (1)

  • Evolution of adaptative behaviour

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

    At 12 months

Secondary Outcomes (10)

  • Evolution of adaptative behaviour

    At 6 months

  • Evolution of development

    At 12 months

  • Pain evaluation

    At 12 months

  • Durability of acquired cognitive-motor abilities

    at 18 months

  • Durability of acquired cognitive-motor abilities

    at 18 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

patients will receive intensive care of rehabilitation of psychomotor

Behavioral: Intentive rehabilitation

Control group

ACTIVE COMPARATOR

patients will receive standard care

Behavioral: Routine care

Interventions

Intentive rehabilitationBEHAVIORAL

Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.

Intervention group
Routine careBEHAVIORAL

Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.

Control group

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital San Salvadour

Hyères, Var, 83407, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 11743709BACKGROUND

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

    PMID: 20526405BACKGROUND

  • 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.

    PMID: 31392551BACKGROUND

Study Officials

  • Marie-Christine ROUSSEAU, MD

    Polyhandicap adultes San Salvadour, APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Christine ROUSSEAU, MD

CONTACT

+33 (4) 94 38 08 17marie-Christine.rousseau@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 21, 2020

Study Start

June 20, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

FR(1)