NCT04759326 Neurorehabilitation Through Hippotherapy of a Brain Stroke

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This trial targets 52 participants in total. It began in 2022-04-27 with a primary completion date of 2025-11.

Brief Summary

Cerebrovascular accident \[CVA\] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke. The aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers. A prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life. Program evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 18 years old * Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 (30) * Inclusion \> 3 months post-stroke * Deficit still existing (Rankin score ≥ 3 and ≤ 4 at inclusion) * Existing declaration of informed consent * Affiliation of the patient to a social security scheme * Minimal abduction of the hip of 25 degrees bilateral with no history of hip dislocation and/or dysplasia * Certificate of non-contraindication issued by the referring physician Exclusion Criteria: * Major cognitive impairment affecting comprehension (Mini Mental State Examination test \< 24 points) * Global or sensory aphasia * Neurological or psychiatric co-morbidity (other than mild-to-moderate post-stroke depression) * Evidence of an uncontrolled seizure disorder * Substance abuse * History of uncontrolled pain * History of allergic reactions to dust and/or horsehair, or severe asthma * Overweight (≥ 110 kg) * Contraindications to physical activity * Inability or medical contraindication to travel to the Equiphoria Institute by personal car or taxi * History of horse riding or hippotherapy care during the last 6 months * Pregnant or lactating women * Patients participating in other biomedical research or in a period of exclusion

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