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

March 22, 2022 updated by: Escoles Universitaries Gimbernat

Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Barcelona
      • Esplugues De Llobregat, Barcelona, Spain, 08950
        • Hospital Universitari de Sant Joan de Déu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control Group
Regular follow ups.
EXPERIMENTAL: Intervention Group
One weekly session (1 hour) of Horse-Assisted Rehabilitation, 24 weeks.
Other: Horse-Assisted Rehabilitation
One hour weelky session of hippotherapy.
Other Names:
  • Hippotherapy
  • Equine-Assisted Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported Quality Of Life Changes
Time Frame: Baseline and 25th week
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent-Proxys Reported Quality Of Life Changes
Time Frame: Baseline and 25th week
Pediatric Quality of Life Inventory - Parent-Proxy Report (PedsQL-PC) (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
General Health Status Changes
Time Frame: Baseline and 25th week
Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).
Baseline and 25th week
Anxiety Changes
Time Frame: Baseline and 25th week
State Trait Ansiety IInventory for children (STAI-CH) - norm-referenced scores (T scores and percentile ranks) for each one of the two subscales: Anxiety-Trait & Anxiety-State (scores 0-60 in each subscale, higher = worse).
Baseline and 25th week
Depression Changes
Time Frame: Baseline and 25th week
Childhood Depression Inventory (CDI), self report long version (28 items) to assess the presence and severity of depressive symptoms in children. Scores range from 0-56, with higher scores indicating higher levels of depression.
Baseline and 25th week
Behavior Changes
Time Frame: Baseline and 25th week
Behavior Assessment System for Children - Parent Rating Scale (BASC-PRS), second version (BASC-2) - BASC-2 is parent-reported, well-established scale for externalizing/internalizing problem of children and adolescents. Scoring manual and software is provided by the assessment developers; norm-referenced scores (T scores and percentile ranks) are available in the score reports, as are interpretations of strengths and weaknesses and target behaviors for intervention (mean of 50 and standard deviation of 10; for the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic).
Baseline and 25th week
Self-Reported Physical Function Changes
Time Frame: Baseline and 25th week
PedsQL-C (subscale Health and Activities: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Baseline and 25th week
Parents-Reported Physical Function Changes
Time Frame: Baseline and 25th week
PedsQL-PC (subscale Physical Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Baseline and 25th week
Self-Reported Emotional Function Changes
Time Frame: Baseline and 25th week
PedsQL-C (subscale Feelings: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Baseline and 25th week
Parent-Reported Emotional Function Changes
Time Frame: Baseline and 25th week
PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Baseline and 25th week
Self-Reported Sociability Function Changes
Time Frame: Baseline and 25th week
PedsQL-C (subscale Get Along with Others: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Baseline and 25th week
Parent-Reported Sociability Function Changes
Time Frame: Baseline and 25th week
PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)
Baseline and 25th week
Balance Changes
Time Frame: Baseline, 6th, 12th and 25th week
Pediatric Balance Scale (PBS: 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks; Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The highest score in PBS is 56, higher is better).
Baseline, 6th, 12th and 25th week
Position Changes
Time Frame: Baseline, 6th, 12th and 25th week
Sitting Assessment Scale (Sitting Assessment Scale (SAS) is a standardized observational instrument designed for assessment of sitting in children with cerebral palsy (CP); the scale is composed of five items evaluating head, trunk and foot control and arm and hand function, where each item is assessed with a score from 1 to 4 (1 =none; 2=poor; 3=fair; 4=good) and each score (1,2,3,4) has specific decriptors of each item of the SAS).
Baseline, 6th, 12th and 25th week
Proprioception-Coordination Changes
Time Frame: Baseline and 25th week
Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07: the DCDQ is a brief questionnaire designed to screen for coordination disorders in children, aged 5 to 15 years, and consists of 15 items grouped into three distinct factors (motor control during movement, fine motor and handwriting and general coordination; to reach scores, sum each column to compute the numbers onto the Score Sheet, and add all factor scores to compute a Total Score: 0-75, higher is better).
Baseline and 25th week
Autonomous Neurvous System activation function Changes
Time Frame: Baseline, 6th, 12th and 25th week
Heart Rate Variability (HRV, low/high frequency (LH/FH) power ratio; modulation of heart rate variability assessed through analysis of data collected by HRV wireless monitorisation and PolarH7(R) thoracic band (medical device), following the American and European Cardiological Societies).
Baseline, 6th, 12th and 25th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escoles Universitaries Gimbernat

Collaborators

Hospital Vall d'Hebron
Hospital Sant Joan de Deu

Investigators

  • Study Director: Jordi Esquirol Caussa, PhD, MD, Escoles Universitaries Gimbernat
  • Principal Investigator: Teresa Xipell Prunés, PT, Escoles Universitaries Gimbernat

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2019

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 24, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HARHB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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