NCT05755295

Brief Summary

On average, each year in the former region, 60 new patients under the age of 18 are treated for a brain tumor, with an active post-treatment follow-up file of 350 patients. Because of the significant sequelae induced by the disease or the treatments, these patients will very often require rehabilitative care. The interest of involving the horse in the population of patients cured of a medulloblastoma but with important physical and psychological after-effects is to be able to combine a therapy using animal mediation (equitherapy) and a rehabilitation therapy based on the three-dimensional movement of the horse (hippotherapy).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

February 22, 2023

Last Update Submit

July 11, 2023

Conditions

Neuroblastoma

Keywords

hippotherapyequitherapy

Outcome Measures

Primary Outcomes (1)

  • number of sessions performed

    number of sessions equitherapy and hippotherapy performed

    16 weeks

Study Arms (1)

horse therapy

EXPERIMENTAL
Other: horse therapy

Interventions

horse therapyOTHER

equitherapy and hippotherapy once a week during 16 weeks

horse therapy

Eligibility Criteria

Age10 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • complete remission of medulloblastoma and after 5 years of the end of treatment
  • living within 30 km away the riding center and/or less than 1 hour of transport
  • informed consent

You may not qualify if:

  • Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years
  • major under juridical protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Neuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Anne-Isabelle BERTOZZI, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Isabelle BERTOZZI, MD

CONTACT

05 34 55 86 83bertozzi.ai@chu-toulouse.fr

Françoise AURIOL, MD

CONTACT

auriol.f@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 6, 2023

Study Start

April 3, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)