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).

NCT06713538 | Completed

• 1 other identifier: 2019-A02966-51
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)

Secondary Outcomes (7)

• Evaluation of balance

  Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)

• Evaluation of Self-Esteem - Rosenberg

  Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)

• Evaluation of Anxiety and depression

  Pre-test (before intervention), Post-test (immediately after intervention) and Post-test2 (3months after intervention)

• Evaluation of gait

  Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)

• Evaluation of functional independence

  Pre-test (before intervention), Post-test (immediately after intervention) and Post-test 2 (3months after intervention)

Study Arms (2)

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.).

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.

Other: Physical activity

Interventions

Equine assisted therapy OTHER

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:

Experimental group

Physical activity OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hopital La Musse: lead
• Institut Français du Cheval et de l'Equitation IFCE: collaborator

Study Sites (1)

Hôpital La Musse

Saint-Sébastien-de-Morsent, 27180, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction

Interventions

Equine-Assisted Therapy; Exercise

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive 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; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: April 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

FR (1)