Equine Therapy Programme on Stress, Autonomy and Balance in School-age Children With Intellectual Disabilities

March 25, 2026 updated by: Lara Martínez, Universidad Pontificia Comillas

Influence of an Equine Therapy Programme on Variables Related to Stress, Autonomy and Balance in School-age Children With Intellectual Disabilities

The aim of this study is to determine the impact of an equine therapy programme on the emotional state and autonomy of school-aged individuals with intellectual disabilities. Methodology: pre-post quasi-experimental study of a single group. Study subjects: individuals with intellectual disabilities enrolled at the Cambrils special education school. Variables related to stress (salivary cortisol), balance, autonomy, vital signs (blood pressure, heart rate, pulse oximetry) and clinical variables will be collected. Intervention: this will consist of 30 minutes of equine therapy and 30 minutes of activities related to horse care. All variables will be collected in an initial baseline measurement and some variables (stress, balance, autonomy and vital signs) will be monitored during and after the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Horse-assisted therapy (HAT) or equine therapy has been defined by the National Centre for Equine Facilitated Therapy as a treatment strategy that uses equine movement as part of a coordinated intervention programme to achieve physical, emotional, occupational, and cognitive goals. The objective of this study is to determine the impact of an equine therapy programme on the emotional state and autonomy of school-aged individuals with intellectual disabilities. Methodology: pre-post quasi-experimental study of a single group. The research will be carried out at the facilities of the Yabusan Equestrian Club. Study subjects: individuals with intellectual disabilities enrolled at the Cambrils special education school. Variables related to stress (salivary cortisol), balance, autonomy, vital signs (blood pressure, heart rate, pulse oximetry), and clinical variables will be collected. Intervention: This will consist of 30 minutes of horse therapy in which the subject participates according to the degree of their disability. There are three types of therapy: hippotherapy, therapeutic riding, and adapted riding. The second intervention consists of 30 minutes of activities related to horse care (feeding, grooming, physical contact). Follow-up and data collection: all variables will be collected in an initial baseline measurement, and some variables (stress, balance, autonomy, and vital signs) will be monitored during and after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Madrid
      • Madrid, Madrid, Spain, 28036
        • Paseo de La Habana 70 Bis

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age under 22 years.
  • IQ equal to or less than 75.
  • Recognised degree of disability equal to or greater than 33%.

Exclusion Criteria:

  • Subjects with adrenal gland disorders (Cushing's or Addison's disease).
  • Subjects undergoing treatment with corticosteroids.
  • Subjects with skin lesions in the area where the portable device is placed.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EQUINE THERAPY
EQUINE THERAPY AND HORSE CARE
Other: EQUINE THERAPY
EQUINE THERAPY AND HORSE CARE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
STRESS LEVEL-HEART RATE
Time Frame: Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
Heart rate will be measured by Embraceplus™ device. It is a smartwatch. t will be measured in beats per minute.
Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
STRESS LEVEL-OXYGEN SATURATION
Time Frame: Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
Oxygen saturation will be measured by Embraceplus™ device. It is a smartwatch. It will be measured as a percentage of spO2. This value indicates the proportion of haemoglobin in the blood that is bound to oxygen relative to the total haemoglobin available.
Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
STRESS LEVEL-RESPIRATORY RATE (RR)
Time Frame: Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
Respiratory rate will be measured by Embraceplus™ device. It is a smartwatch. It will be measured as breaths per minute.
Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
STRESS LEVEL-BODY TEMPERATURE
Time Frame: Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
Body temperature will be measured by Embraceplus™ device. It is a smartwatch. It will be measured in degrees Celsius.
Basal measurement before/after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device for up to 4 hours before and after the session. Measurements every 15 days until the final of the Equine Therapy (3 months)
STRESS LEVEL-ELECTRODERMAL ACTIVITY (EDA)
Time Frame: Measurement before and after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device prior to and up to 4 hours after the end of the session.
Electrodermal Activity will be measured by Embraceplus™ device. It is a smartwatch. Electrodermal Activity is the variation in the electrical conductance of the skin caused by the activity of the sweat glands, regulated by the sympathetic autonomic nervous system, and is used to measure emotional arousal, stress, or physiological responses to stimuli, using electrodes that measure changes in skin resistance. It is useful in psychology, neuromarketing, and medicine to detect anxiety, depression, or autonomic neuropathy.
Measurement before and after each session. On the day of the equine therapy sessions, subjects will wear the Embraceplus™ device prior to and up to 4 hours after the end of the session.
AUTONOMY
Time Frame: Before the start of therapy (baseline assessment) and at the end of therapy (3 months)
The level of autonomy or dependency will be assessed through adaptive behaviour using the Diagnostic Adaptive Behaviour Scale (DABS). The DABS is a tool that assesses a person's ability to function in daily life and determines whether there are significant deficits in this area, which is a fundamental criterion for the diagnosis of intellectual disability and other developmental disorders. Designed by the American Association on Intellectual and Developmental Disabilities (AAIDD), the DABS is administered to individuals aged 4 to 21 and provides scores on the conceptual, social, and practical dimensions of adaptive behaviour.
Before the start of therapy (baseline assessment) and at the end of therapy (3 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BALANCE
Time Frame: Before the start of therapy (baseline assessment) and at the end of therapy (3 months) and 6 month.
It will be evaluated by collecting kinetic variables through the PhysioSensing Vestibular pressure platform. Pressure platforms use a set of pressure sensors, in this case 4,000, to measure the distribution of pressure exerted during footfall. They enable the recording and evaluation of pressure values under the foot in static or dynamic conditions, and are used for diagnosis and evaluation of foot function and balance. Thanks to the use of pressure sensors, it is possible to obtain reliable and accurate measurement data, which is essential in clinical and research applications.
Before the start of therapy (baseline assessment) and at the end of therapy (3 months) and 6 month.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
VITAL SIGNS - BLOOD PRESSURE (BP)
Time Frame: Basal measurement before/after each session. Measurements every 15 days until the final of the Equine Therapy (3 months)
Blood pressure will be measured using a validated digital blood pressure monitor, and the measurement will be taken in mm Hg.
Basal measurement before/after each session. Measurements every 15 days until the final of the Equine Therapy (3 months)
AGE
Time Frame: Before the sessions
Age will be measure in years
Before the sessions
SEX
Time Frame: Before the sessions
Male/Female
Before the sessions
RECOGNISED DEGREE OF DISABILITY
Time Frame: Before the sessions
Collection of relevant clinical data regarding the participants' intellectual disability profile, measured by percentage (%)
Before the sessions

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Pontificia Comillas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundación San Juan de Dios

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20/004-EQUINE THERAPY
  • P25/06 (Other Grant/Funding Number: FUNDACIÓN SAN JUAN DE DIOS)

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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