- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07497035
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
60
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
-
-
Madrid
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: EQUINE THERAPY
EQUINE THERAPY AND HORSE CARE
|
EQUINE THERAPY AND HORSE CARE
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Collaborators
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 10, 2025
Primary Completion (Estimated)
May 25, 2026
Study Completion (Estimated)
July 6, 2026
Study Registration Dates
First Submitted
December 10, 2025
First Submitted That Met QC Criteria
March 25, 2026
First Posted (Actual)
March 27, 2026
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 25, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Intellectual Disability
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Animal Assisted Therapy
- Equine-Assisted Therapy
Other Study ID 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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