Traumatic Brain Injury (TBI) PatientsEPONANCT06713538
Impact of a Standardized Equine Mediation Program on the Evolution of the Psycho-behavioral Profile of Adults With Traumatic Brain Injuries Experiencing Impaired Quality of Life (EPONA).
A study testing Equine assisted therapy and Physical activity in people with Traumatic Brain Injury (TBI) Patients and Equine-assisted Therapy, run by Hopital La Musse at 1 site in France.
Trial summary
In France, 155,000 traumatic brain injuries (TBIs) are treated annually, representing a major public health challenge. The sequelae vary depending on the lesions and include a range of motor disorders as well as complex cognitive and psycho-behavioral impairments that significantly affect autonomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Equine-assisted Therapy, Cognitive Disorders
- What is being tested?
- Equine assisted therapy and Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years.
- Presenting a traumatic brain injury with a non-progressive lesion that occurred at least three months ago (identified using the Neurobehavioural Rating Scale Revised (NRS-R))
- Patients with mild to severe psycho-behavioral disorders
- Subjects must be autonomous for mobility (with or without technical assistance)
- Must not be allergic to horses.
- Able to remain in a seated and standing position (with or without technical assistance).
- Have at least one functional upper limb (to interact with the horse).
- A cognitive level equivalent to primary school (CM1/CM2) enabling the completion of questionnaires.
Who cannot join
- Pregnant or breastfeeding women
- Individuals in emergency situations
- Individuals participating simultaneously in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Standardized Equine Mediation Program on the Evolution of the Psycho-behavioral Profile of Adults With Traumatic Brain Injuries Experiencing Impaired Quality of Life.
In France, 155,000 traumatic brain injuries (TBIs) are treated annually, representing a major public health challenge. The sequelae vary depending on the lesions and include a range of motor disorders as well as complex cognitive and psycho-behavioral impairments that significantly affect autonomy. Psycho-behavioral disorders are present in 75% of cases and hinder the process of social reintegration. The relationships between quality of life, social functioning, and psycho-behavioral profiles raise significant questions within the scientific and medical communities, emphasizing the need for the development of specific care programs for this population.
While non-pharmacological interventions are recommended as a first-line approach at all stages of care, existing therapeutic programs have not demonstrated sufficient effectiveness. As maintaining TBI patients within their communities becomes a priority, aligned with ministerial and HAS (French National Health Authority) recommendations, equine mediation appears to hold significant potential, particularly for addressing psycho-behavioral disorders. These therapeutic techniques have gained considerable traction in recent years, with literature reviews indicating effectiveness across diverse populations (e.g., Autism, Mental Health). However, to our knowledge, no studies have evaluated the potential benefits of equine mediation for TBI patients.
Read more
In light of these observations, the EPONA study aims to assess the impact of a standardized horse-assisted therapeutic program on the evolution of the psycho-behavioral profile of TBI patients. The secondary objectives of the study are to measure the impact of this program on the evolution of motor and cognitive profiles, psychological pain, the level of autonomy, social participation, and quality of life.
The primary judgment criterion evaluates the psycho-behavioral profile Brief-A Behavioral Regulation Index Roth 2005 The secondary judgment criteria evaluate impairments activity limitations and participation restrictions For impairments we analyze the cognitive profile with the questionnaire Brief-A Roth 2005 the balance via the Timed Up and Go test the psychological pain with the Rosenberg Self-Esteem Scale Rosenberg 1965 and anxiety via the Hospital Anxiety and Depression Scale Zigmond 1983 For activity limitations we evaluate walking with the Six-Minute Walk Test Guyatt 1985 as well as the level of functional independence Calmels 2009 For participation restrictions we evaluate social participation with the MHAVIE scale Fougeyrollas 2003 as well as quality of life using the QoLIBRI Von Steinbüchel 2005 and CSQ-8 Larsen 1979 scales.
For this single-blind randomized study, 50 traumatic brain injury subjects will be recruited at the Hôpital de la Musse Saint Sébastien de Morsent. Depending on the randomization, patients will be assigned either to the experimental group or the control group. For the experimental group, patients will undergo 12 sessions of equine mediation, with 2 sessions of 90 minutes per week for 6 weeks. For the control group, patients will undergo 12 sessions of physical activity, with 2 sessions of 90 minutes per week for 6 weeks.
- Conditions
- Traumatic Brain Injury (TBI) Patients, Equine-assisted Therapy, Cognitive Disorders, Quality of Life
- Being tested
- Equine assisted therapy, Physical activity
- Keywords
- Traumatic Brain Injury, Equine Mediation, Cognitive profile, Quality of life
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine assisted therapyOther
The intervention will last for 12 sessions, with two 1.5-hour sessions per week. The program is offered to patients in addition to their usual daily schedule. These 12 sessions will be organized as follows:
Physical activityOther
The subjects will independently carry out 12 sessions (2 sessions of 90 minutes per week for 6 weeks) of moderate-intensity physical activity. The endurance activity should be performed according to the patient's capabilities and fatigue levels.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental setup corresponds to a standardized and progressive program of 12 sessions (2 sessions of 90 minutes per week for 6 weeks) of ground work with the horse. These sessions will be protocolized and themed, addressing psycho-behavioral issues commonly found in traumatic brain injury patients (emotion management, strategy development, problem-solving, analysis and interpretation of others' behavior, etc.). Receives: Other: Equine assisted therapy |
| Control group | Active comparator | The control setup is based on global recommendations for physical activity for health (WHO), which advise 150 to 300 minutes of moderate endurance activity per week for a positive impact on physical, cognitive, and psychological health for the 18-65 age group.
Following these recommendations, the subjects will independently carry out 12 sessions (2 sessions of 90 minutes per week for 6 weeks) of moderate-intensity physical activity. The endurance activity should be performed according to the patient's capabilities and fatigue levels. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of psycho-behavioral profile
The psycho-behavioral profile of the patient will be assessed using the Behavior Rating Inventory of Executive Function-Adult Version (Brief-A).
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Secondary outcomes (7)
Evaluation of balance
Evaluation of balance using the Timed Up and Go (TUG) test, which assesses the static and dynamic balance of patients and helps predict their risk of falling.
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of Self-Esteem - Rosenberg
Evaluation of Self-Esteem is carried out using the Rosenberg Scale. The score on this scale ranges from 10 to 40. The lower the score, the lower the self-esteem.
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of Anxiety and depression
Evaluation of Anxiety and depression is carried out using the Hospital Anxiety and Depression Scale (HADS). Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21). The higher the scores, the more anxious and depressed the patient.
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test2 (3months after intervention)
Evaluation of gait
The patients' walking ability is evaluated using the 6-Minute Walk Test.
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of functional independence
Evaluation of functional independence is assessed using the Functional Independence Measure (FIM).
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of social participation
Evaluation of social participation is typically assessed using the measuring lifestyle habits (MHAVIE) scale. Each item is scored from 0 to 9, with a score of zero indicating total disability or interruption of participation, and a score of nine indicating optimal participation. The total LIFE-HM score is obtained by adding up the scores for each item, then dividing by the number of items (calculating an average). The higher the score, the greater the patient's optimal level of participation.
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of quality of life
Evaluation of quality of life is typically assessed using the Quality of Life in Brain Injury (QoLIBRI) scale, which is designed specifically for individuals with brain injuries. The QOLIBRI questionnaire comprises 37 items rated from 1 to 5. The total score is divided by the number of items to calculate the average. The higher the average, the worse the patient's quality of life.
Measured: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start18 Apr 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital La Musse
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Français du Cheval et de l'Equitation IFCE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713538
- Sponsor's protocol ID
- 2019-A02966-51
- Acronym
- EPONA
- Status last verified
- May 2025
- First submitted
- 25 Nov 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Standardized Equine Mediation Program on the Evolution of the Psycho-behavioral Profile of Adults With Traumatic Brain Injuries Experiencing Impaired Quality of Life.
- ClinicalTrials.gov ID
- NCT06713538
- Acronym / sponsor ID
- EPONA / 2019-A02966-51
- Conditions
- Traumatic Brain Injury (TBI) Patients, Equine-assisted Therapy, Cognitive Disorders, Quality of Life
- Keywords
- Traumatic Brain Injury, Equine Mediation, Cognitive profile, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hopital La MusseUniversity, hospital or other
- Collaborators
- Institut Français du Cheval et de l'Equitation IFCE
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Dec 2024 (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.
In France, 155,000 traumatic brain injuries (TBIs) are treated annually, representing a major public health challenge. The sequelae vary depending on the lesions and include a range of motor disorders as well as complex cognitive and psycho-behavioral impairments that significantly affect autonomy. Psycho-behavioral disorders are present in 75% of cases and hinder the process of social reintegration. The relationships between quality of life, social functioning, and psycho-behavioral profiles raise significant questions within the scientific and medical communities, emphasizing the need for the development of specific care programs for this population.
While non-pharmacological interventions are recommended as a first-line approach at all stages of care, existing therapeutic programs have not demonstrated sufficient effectiveness. As maintaining TBI patients within their communities becomes a priority, aligned with ministerial and HAS (French National Health Authority) recommendations, equine mediation appears to hold significant potential, particularly for addressing psycho-behavioral disorders. These therapeutic techniques have gained considerable traction in recent years, with literature reviews indicating effectiveness across diverse populations (e.g., Autism, Mental Health). However, to our knowledge, no studies have evaluated the potential benefits of equine mediation for TBI patients.
In light of these observations, the EPONA study aims to assess the impact of a standardized horse-assisted therapeutic program on the evolution of the psycho-behavioral profile of TBI patients. The secondary objectives of the study are to measure the impact of this program on the evolution of motor and cognitive profiles, psychological pain, the level of autonomy, social participation, and quality of life.
The primary judgment criterion evaluates the psycho-behavioral profile Brief-A Behavioral Regulation Index Roth 2005 The secondary judgment criteria evaluate impairments activity limitations and participation restrictions For impairments we analyze the cognitive profile with the questionnaire Brief-A Roth 2005 the balance via the Timed Up and Go test the psychological pain with the Rosenberg Self-Esteem Scale Rosenberg 1965 and anxiety via the Hospital Anxiety and Depression Scale Zigmond 1983 For activity limitations we evaluate walking with the Six-Minute Walk Test Guyatt 1985 as well as the level of functional independence Calmels 2009 For participation restrictions we evaluate social participation with the MHAVIE scale Fougeyrollas 2003 as well as quality of life using the QoLIBRI Von Steinbüchel 2005 and CSQ-8 Larsen 1979 scales.
For this single-blind randomized study, 50 traumatic brain injury subjects will be recruited at the Hôpital de la Musse Saint Sébastien de Morsent. Depending on the randomization, patients will be assigned either to the experimental group or the control group. For the experimental group, patients will undergo 12 sessions of equine mediation, with 2 sessions of 90 minutes per week for 6 weeks. For the control group, patients will undergo 12 sessions of physical activity, with 2 sessions of 90 minutes per week for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Equine assisted therapyThe experimental setup corresponds to a standardized and progressive program of 12 sessions (2 sessions of 90 minutes per week for 6 weeks) of ground work with the horse. These sessions will be protocolized and themed, addressing psycho-behavioral issues commonly found in traumatic brain injury patients (emotion management, strategy development, problem-solving, analysis and interpretation of others' behavior, etc.). |
| Control group | Active comparator | Other: Physical activityThe control setup is based on global recommendations for physical activity for health (WHO), which advise 150 to 300 minutes of moderate endurance activity per week for a positive impact on physical, cognitive, and psychological health for the 18-65 age group. Following these recommendations, the subjects will independently carry out 12 sessions (2 sessions of 90 minutes per week for 6 weeks) of moderate-intensity physical activity. The endurance activity should be performed according to the patient's capabilities and fatigue levels. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 65 years.
- Presenting a traumatic brain injury with a non-progressive lesion that occurred at least three months ago (identified using the Neurobehavioural Rating Scale Revised (NRS-R))
- Patients with mild to severe psycho-behavioral disorders
- Subjects must be autonomous for mobility (with or without technical assistance)
- Must not be allergic to horses.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women
- Individuals in emergency situations
- Individuals participating simultaneously in another study.
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 assisted therapyThe intervention will last for 12 sessions, with two 1.5-hour sessions per week. The program is offered to patients in addition to their usual daily schedule. These 12 sessions will be organized as follows: | Other | Experimental group |
| Physical activityThe subjects will independently carry out 12 sessions (2 sessions of 90 minutes per week for 6 weeks) of moderate-intensity physical activity. The endurance activity should be performed according to the patient's capabilities and fatigue levels. | Other | Control group |
Primary outcome
Evaluation of psycho-behavioral profile
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
The psycho-behavioral profile of the patient will be assessed using the Behavior Rating Inventory of Executive Function-Adult Version (Brief-A).
7 secondary outcomes
Evaluation of balance
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of Self-Esteem - Rosenberg
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of Anxiety and depression
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test2 (3months after intervention)
Evaluation of gait
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of functional independence
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of social participation
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Evaluation of quality of life
Time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
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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 assisted therapy and Physical activity in people with Traumatic Brain Injury (TBI) Patients and Equine-assisted Therapy, run by Hopital La Musse at 1 site in France.
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 8 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: finished, as of the sponsor's last update on 11 May 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of psycho-behavioral profile (time frame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)). 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 11 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.