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.
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)
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
Parallel
Hippotherapy
Other interventionHippotherapy is an emerging specialized rehabilitation approach, performed on a specially trained horse via its movement at a walk by accredited health professionals (e.g., physicians, psychologists, physical therapists, occupational therapists, psychomotor therapists, chiropractors ...). The horse is an excellent support for temporary or consolidated disabilities, providing key elements of recovery for impairment, activity limitation, and participation restriction. It is a dynamic activity where the amplitude of movement of the patient's body transmitted by the horse is similar to the human walking (micro-movements of postural muscles). Moreover, through multimodal inputs (sensory, exteroceptive, proprioceptive, interoceptive), hippotherapy has a direct action on the individual's motor capacities and cognitive abilities. The degree of change relying on neuroplasticity is linked both to the relevance of the activity and to the intensity and frequency of the elements that constitute it.
Conventional Neurorehabilitation
Other interventionThe neurorehabilitation therapy is an intervention from two or more disciplines (physiotherapy, occupational therapy, social work, psychology and other related disciplines, nursing) prescribed by a medical specialist (neurologist, neurosurgeon, oncologist, physiatrist). It is designed to be patient-centered, time-limited and functionally oriented, and aims to maximize activity and participation (social inclusion) using a biopsychosocial model.
For the patient: Change in Functional Independence Measure (FIM)
FIM is an 18-item of physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. Tasks that are evaluated using the FIM include bowel and bladder control, transfers, locomotion, communication, social cognition as well as the following six self-care activities: Feeding, Grooming, Bathing, Upper Body Dressing, Lower Body Dressing, Toileting. Each item on the FIM is scored on a 7-point Likert scale, and the score indicates the amount of assistance required to perform each item (1 = total assistance in all areas, 7 = total independence in all areas). A final summed score is created and ranges from 18 - 126, where 18 represents complete dependence/total assistance and 126 represents complete independence.
For the patient: Change in Modified Rankin Scale (MRS)
MRS is a standardized measure that describes the extent of disability after a stroke. The MRS is a single item scale. It ranges from 0 (no symptoms) to 6 (death due to stroke).
For the patient: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
FMA is a stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain. Assessment items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 = cannot accomplish; 1 = partially accomplished; and 2 = completely accomplished (0-35 = Very severe; 36-55 = Severe; 56-79 = Moderate; \> 79 = Light). The total possible result for the evaluation is 226 points.
For the patient: Change in Berg Balance Scale (BBS)
BBS was developed for use with community-dwelling elderly individuals. It can also be used in patients with stroke. It is a 14-item scale where patients must maintain positions and complete moving tasks of varying difficulty. In most items, patients must maintain a given position for a specified time. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item.
For the patient: Change in Displacement of the Centre of Pressure (COP) while sitting through a force pad
Assessment of the displacement of COP during dynamic sitting on the horse simulator (TESS©) equipped with saddle pressure sensors. This measurement allows to assess the postural balance improvement. A trained observer records the sequence.
Click on the lead sponsor to view all of their trials.
Alliance Equiphoria
Lead sponsor
Boehringer Ingelheim
Collaborator
Centre Hospitalier Sud Francilien
Collaborator
Centre Hospitalier de Béziers
Collaborator
University Hospital, Grenoble
Collaborator
