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

NCT07497035 | Active Not Recruiting

• 2 other identifiers: 20/004-EQUINE THERAPYP25/06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intellectual Disability

Keywords

Equine Therapy; intellectual disability; balance; autonomy; stress level

Outcome Measures

Primary Outcomes (6)

• STRESS LEVEL-HEART RATE

  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

  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)

  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

  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)

  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

  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 Outcomes (1)

• BALANCE

  Before the start of therapy (baseline assessment) and at the end of therapy (3 months) and 6 month.

Other Outcomes (4)

• VITAL SIGNS - BLOOD PRESSURE (BP)

  Basal measurement before/after each session. Measurements every 15 days until the final of the Equine Therapy (3 months)

• AGE

  Before the sessions

• SEX

  Before the sessions

Study Arms (1)

EQUINE THERAPY

EXPERIMENTAL

EQUINE THERAPY AND HORSE CARE

Other: EQUINE THERAPY

Interventions

EQUINE THERAPY OTHER

EQUINE THERAPY AND HORSE CARE

EQUINE THERAPY

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia Comillas: lead
• Fundación San Juan de Dios: collaborator

Study Sites (1)

Paseo de La Habana 70 Bis

Madrid, Madrid, 28036, Spain

Location

MeSH Terms

Conditions

Intellectual Disability

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: March 27, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): July 6, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)