Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

NCT ID: NCT04070131

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2022-06-01

Brief Summary

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Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.

Detailed Description

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Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.

Conditions

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Cancer Child, Only Child Behavior Neurologic Gait Disorder Neurologic Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

Regular follow ups.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks.

Group Type EXPERIMENTAL

Horse-Assisted Rehabilitation

Intervention Type OTHER

One hour weelky session of hippotherapy.

Interventions

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Horse-Assisted Rehabilitation

One hour weelky session of hippotherapy.

Intervention Type OTHER

Other Intervention Names

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Equine-Assisted Rehabilitation Hippotherapy

Eligibility Criteria

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Inclusion Criteria

* Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System
* With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability
* More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy)

Exclusion Criteria

* Immunodepression
* Hypotonia with severe pelvic instability that does not allow seating on the horse safely
* Weight greater than 80Kg.
* Phobia to horses
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Hospital Sant Joan de Deu

OTHER

Sponsor Role collaborator

Escoles Universitaries Gimbernat

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordi Esquirol Caussa, PhD, MD

Role: STUDY_DIRECTOR

Escoles Universitàries Gimbernat

Teresa Xipell Prunés, PT

Role: PRINCIPAL_INVESTIGATOR

Escoles Universitàries Gimbernat

Locations

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Hospital Universitari de Sant Joan de Déu

Esplugues de Llobregat, Barcelona, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Other Identifiers

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HARHB

Identifier Type: -

Identifier Source: org_study_id

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