NeuroblastomaEQUI-HIPPONCT05755295
Horse Therapy for Children, Adolescents and Young Adults in Remission From Medulloblastoma
A study testing horse therapy in people with Neuroblastoma, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 26 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- horse therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years
- major under juridical protection
Trial locations and contacts
1 site in 1 country.
Françoise AURIOL, MD contact
France1 site, 1 recruiting
- Recruiting
CHU de Toulouse
Toulouse, 31059
Anne-Isabelle BERTOZZI, MD, 0561772233, bertozzi.ai@chu-toulouse.fr
About this study
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
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).
- Conditions
- Neuroblastoma
- Being tested
- horse therapy
- Keywords
- hippotherapy, equitherapy
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
horse therapyOther
equitherapy and hippotherapy once a week during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| horse therapy | Experimental | Not described Receives: Other: horse therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sessions performed
number of sessions equitherapy and hippotherapy performed
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 Apr 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Isabelle BERTOZZI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755295
- Sponsor's protocol ID
- RC31/22/0218
- Acronym
- EQUI-HIPPO
- Status last verified
- Jul 2023
- First submitted
- 22 Feb 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05755295
- Acronym / sponsor ID
- EQUI-HIPPO / RC31/22/0218
- Conditions
- Neuroblastoma
- Keywords
- hippotherapy, equitherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| horse therapy | Experimental | Other: horse therapy |
Who may qualify
- Ages
- 10 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Landsky score below 50% for minors until 16 years old and Karnofsky score below 50% for patients over 16 years
- major under juridical protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| horse therapyequitherapy and hippotherapy once a week during 16 weeks | Other | horse therapy |
Primary outcome
number of sessions performed
Time frame: 16 weeks
number of sessions equitherapy and hippotherapy performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Neuroblastoma
RecruitingPhase 1/2
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise AURIOL, MD contact
Anne-Isabelle BERTOZZI, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing horse therapy in people with Neuroblastoma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Isabelle BERTOZZI, MD (05 34 55 86 83 ext. 33, bertozzi.ai@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of sessions performed (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.