NCT06713538: EPONA

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).

Completed NA Last updated 11 May 2025

What this trial tests

NA trial testing Equine assisted therapy in Traumatic Brain Injury (TBI) Patients in 15 participants. Completed in 31 December 2024.

Timeline

18 April 2022

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Hopital La Musse
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	15
Start date	18 April 2022
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across France

Drugs / interventions tested

• Equine assisted therapy
• Physical activity

Conditions studied

• Traumatic Brain Injury (TBI) Patients — all drugs for Traumatic Brain Injury (TBI) Patients →
• Equine-assisted Therapy — all drugs for Equine-assisted Therapy →
• Cognitive Disorders — all drugs for Cognitive Disorders →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Hopital La Musse

Who can join

Adults 18 to 65, any sex, with Traumatic Brain Injury (TBI) Patients or Equine-assisted Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.