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

NCT04070131 | Unknown DMC

• 1 other identifier: HARHB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer; Child, Only; Child Behavior; Neurologic Gait Disorder; Neurologic Complication

Keywords

Child Behavior; Neurologic Gait Disorder; Cancer; Physical Therapy Modalities; Physical Therapy Specialty; Physical and Rehabilitation Medicine; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Self-Reported Quality Of Life Changes

  Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).

  Baseline and 25th week

Secondary Outcomes (15)

• Parent-Proxys Reported Quality Of Life Changes

  Baseline and 25th week

• General Health Status Changes

  Baseline and 25th week

• Anxiety Changes

  Baseline and 25th week

• Depression Changes

  Baseline and 25th week

• Behavior Changes

  Baseline and 25th week

Study Arms (2)

Control Group

NO INTERVENTION

Regular follow ups.

Intervention Group

EXPERIMENTAL

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

Other: Horse-Assisted Rehabilitation

Interventions

Horse-Assisted Rehabilitation OTHER

One hour weelky session of hippotherapy.

Also known as: Equine-Assisted Rehabilitation, Hippotherapy

Intervention Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Escoles Universitaries Gimbernat: lead
• Hospital Vall d'Hebron: collaborator
• Hospital Sant Joan de Deu: collaborator

Study Sites (2)

Hospital Universitari de Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

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MeSH Terms

Conditions

Neoplasms; Child Behavior; Gait Disorders, Neurologic

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jordi Esquirol Caussa, PhD, MD

  Escoles Universitàries Gimbernat

  STUDY DIRECTOR

• Teresa Xipell Prunés, PT

  Escoles Universitàries Gimbernat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 28, 2019
• Study Start: October 15, 2019
• Primary Completion: February 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)