Clinical trial NCT06713538: 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).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hopital La Musse
Sponsor class: OTHER
Collaborators: name: Institut Français du Cheval et de l'Equitation IFCE
First posted: 2024-12-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Individuals in emergency situations
* Individuals participating simultaneously in another study.

Primary outcomes:
measure: Evaluation of psycho-behavioral profile
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Secondary outcomes:
measure: Evaluation of balance
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
measure: Evaluation of Self-Esteem - Rosenberg
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
measure: Evaluation of Anxiety and depression
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test2 (3months after intervention)
measure: Evaluation of gait
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
measure: Evaluation of functional independence
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
measure: Evaluation of social participation
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
measure: Evaluation of quality of life
timeFrame: Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)
Other outcomes:
Locations:
city: Saint Sébastien de Morsent
country: France
facility: Hôpital La Musse
Study officials:
References: