Intellectual DisabilityNCT07497035
Equine Therapy Programme on Stress, Autonomy and Balance in School-age Children With Intellectual Disabilities
A study testing EQUINE THERAPY in people with Intellectual Disability, run by Universidad Pontificia Comillas at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- EQUINE THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2025to 6 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age under 22 years.
- IQ equal to or less than 75.
- Recognised degree of disability equal to or greater than 33%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Intellectual Disability
- Being tested
- EQUINE THERAPY
- Keywords
- Equine Therapy, intellectual disability, balance, autonomy, stress level
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUINE THERAPYOther
EQUINE THERAPY AND HORSE CARE
| Study group | Role | What they receive |
|---|---|---|
| EQUINE THERAPY | Experimental | EQUINE THERAPY AND HORSE CARE Receives: Other: EQUINE THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
STRESS LEVEL-HEART RATE
Heart rate will be measured by Embraceplus™ device. It is a smartwatch. t will be measured in beats per minute.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the start of therapy (baseline assessment) and at the end of therapy (3 months)
Secondary outcomes (1)
BALANCE
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.
Measured: Before the start of therapy (baseline assessment) and at the end of therapy (3 months) and 6 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Oct 2025
- Primary completion25 May 2026 (estimated)
- Study completion6 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación San Juan De Dios
- Responsible party
- Principal investigator, Lara Martínez, Universidad Pontificia Comillas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497035
- Sponsor's protocol ID
- 20/004-EQUINE THERAPY
- Other IDs
- P25/06
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Equine Therapy Programme on Variables Related to Stress, Autonomy and Balance in School-age Children With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT07497035
- Acronym / sponsor ID
- 20/004-EQUINE THERAPY
- Conditions
- Intellectual Disability
- Keywords
- Equine Therapy, intellectual disability, balance, autonomy, stress level
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Collaborators
- Fundación San Juan De Dios
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EQUINE THERAPY | Experimental | Other: EQUINE THERAPYEQUINE THERAPY AND HORSE CARE |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age under 22 years.
- IQ equal to or less than 75.
- Recognised degree of disability equal to or greater than 33%.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EQUINE THERAPYEQUINE THERAPY AND HORSE CARE | Other | EQUINE THERAPY |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
BALANCE
Time frame: Before the start of therapy (baseline assessment) and at the end of therapy (3 months) and 6 month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Intellectual Disability
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
Not yet recruitingPhase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Aggressive Behavior in Fragile X Syndome
Not yet recruitingObservational study
Hematological Profile in Children With Numerical Chromosomal Disorders
Down Syndrome, Turner Syndrome
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
RecruitingObservational study
Defining the Brain Phenotype of Children With Williams Syndrome
Williams Syndrome, Duplication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQUINE THERAPY in people with Intellectual Disability, run by Universidad Pontificia Comillas at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.