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NCT Number: NCT07497035

Equine Therapy Programme on 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paseo de La Habana 70 Bis

Madrid, 28036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EQUINE THERAPY

Other

EQUINE THERAPY AND HORSE CARE

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. AGE

    Time frame: Before the sessions

    Age will be measure in years

  3. SEX

    Time frame: Before the sessions

    Male/Female

  4. RECOGNISED DEGREE OF DISABILITY

    Time frame: Before the sessions

    Collection of relevant clinical data regarding the participants' intellectual disability profile, measured by percentage (%)

Sponsors and collaborators

Lead sponsor

Universidad Pontificia Comillas

Other

Collaborators

  • Fundación San Juan de Dios

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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