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Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma (EQUI-HIPPO)

Primary Purpose

Neuroblastoma

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

horse therapy

About this trial

This is an interventional supportive care trial for Neuroblastoma focused on measuring hippotherapy, equitherapy

Eligibility Criteria

10 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years major under juridical protection

Sites / Locations

CHU de ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

horse therapy

Arm Description

Outcomes

Primary Outcome Measures

number of sessions performed

number of sessions equitherapy and hippotherapy performed

Secondary Outcome Measures

Full Information

NCT ID

NCT05755295

First Posted

February 22, 2023

Last Updated

July 11, 2023

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT05755295

Brief Title

Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma

Acronym

EQUI-HIPPO

Official Title

Pilot Study Evaluating Feasibility and Acceptability of Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma and Describing the Evolution of Their Physical and Psychological Characteristics

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 3, 2023 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroblastoma

Keywords

hippotherapy, equitherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

horse therapy

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

horse therapy

Intervention Description

equitherapy and hippotherapy once a week during 16 weeks

Primary Outcome Measure Information:

Title

number of sessions performed

Description

number of sessions equitherapy and hippotherapy performed

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anne-Isabelle BERTOZZI, MD

Phone

05 34 55 86 83

Ext

bertozzi.ai@chu-toulouse.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Françoise AURIOL, MD

auriol.f@chu-toulouse.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne-Isabelle BERTOZZI, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne-Isabelle BERTOZZI, MD

Phone

0561772233

bertozzi.ai@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma

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