Clinical trial NCT04759326: Neurorehabilitation Through Hippotherapy of a Brain Stroke
Official title: Neurorehabilitation Through Hippotherapy on Neurofunctional Sequels of Brain Stroke: (i) Effect on Patient's Functional Independence, Sensorimotor and Cognitive Capacities and Quality of Life (ii) Effect on Caregivers' Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Accident
Neurorehabilitation
Neuroplasticity
Hippotherapy
Silent Neurofunctional Barriers
Functional Deficit
Cognitive Deficit
Psychological Trauma
Autonomy
Quality of Life
Caregiver Burnout
Keywords: NeuroRehabilitation through hippotherapy
Brain plasticity
Functional recovery
Lead sponsor: Alliance Equiphoria
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Centre Hospitalier Sud Francilien
name: Centre Hospitalier de Béziers
name: University Hospital, Grenoble
First posted: 2021-02-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will use a randomized single-blinded prospective two-arms controlled clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone. To ensure that patients in the two arms of the trial are as homogeneous as possible in all respects except for the planned intervention, randomization will be stratified by age (18-59 years, 60-74 years, and ≥ 75 years), stroke type (ischemic versus hemorrhagic) and degree of disability (Rankin score). Stratified sampling reduces potential confusion by selecting homogeneous subgroups. In this case, matching will ensure a similar distribution of variables that could introduce a major imbalance potentially rendering the results unusable. The study will be single-blinded in order to rule out any possible bias introduced by the experimenter. We will use a fixed randomization defined by the allocation of each treatment (hippotherapy or neurorehabilitation alone).
Primary purpose: TREATMENT

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.

Detailed description: According to the WHO (2016), almost 1.1 million of Europeans suffer a stroke each year (17 million worldwide), which adds to a pool of 33 million stroke survivors. The case fatality rates are about 15% by 1 month, 25% by 1 year, and 50% by 5 years. Over one third of survivors are left disabled (modified Rankin Scale score 3-5) 5 years after stroke due to physical, cognitive, and/or emotional deficits. These deficiencies are often addressed in the hospital's acute care and/or during inpatient rehabilitation. Much of the scientific efforts to date have focused on medical programs involving acute care and hospital-based inpatient rehabilitation. However, many patients continue to experience difficulties beyond this period of recovery and long-term disability often occurs. In such cases, dealing with impairment is frequently ineffective, and when it is beneficial, the functional bases for recovery are mainly unclear.

Stroke is a brutal event in the course of a lifetime. It is a break in reality affecting the body and the psyche, not only for the individual but also for the family. It disrupts the many foundations that a person has built over the course of his or her life. Acceptance of the disease, medical care and its effects on daily life, global impairment, limitation of activity and restriction of participation, are a set of factors that the psyche cannot integrate at once. Following this event, the person and their caregivers must take the time to accept and rebuild themselves. A new sense of temporality is an essential factor in the management of a post-stroke patient and a question that must be addressed by the caregiver.

A body of scientific evidence has gradually emerged in recent years, reflecting the benefits of hippotherapy in various disabling neurological conditions. During hippotherapy, specific execution and repetition of a task are key elements of learning/strengthening/promoting a function and a robust backbone of neurorehabilitation through neural plasticity mechanisms. Hippotherapy is therefore slowly emerging as a cutting-edge method of neurorehabilitation. The post-injury experience is a powerful modulator of functional recovery following neurological disorders. Our method of hippotherapy has powerful effects on brain plasticity and neurological outcome. Beneficial results have been observed in a wide variety of brain disorders and include sensorimotor enhancement, cognitive enhancement, mental well-being, and delayed disease progression. Such an environment most likely promotes the synthesis of different neuroactive substances (e.g., BDNF, norepinephrine, acetylcholine, dopamine, serotonin), which reflect the level of arousal, motivation, attention, affection and emotion of a subject or directly drive the action (e.g., glutamate, or GABA). These endogenous molecules are strongly involved in the induction and maintenance of synaptic plasticity, namely long-lasting stable molecular, anatomical and functional modifications.

In this randomized interventional study, the effectiveness of neurological rehabilitation by hippotherapy will be studied and its scope compared in terms of functional recovery, autonomy and quality of life. Stroke patients will be included and treated from the end of the inpatient rehabilitation phase (starting 3-6 months post-stroke). They will be compared to a control group of patients undergoing conventional outpatient rehabilitation. Both groups will undergo the same qualitative and quantitative clinical tests. We will also compare the quality of life of the respective caregivers before and after the end of the program.

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

Primary outcomes:
measure: For the patient: Change in Functional Independence Measure (FIM)
timeFrame: Change from baseline to week 22; change from week 22 to week 48
Secondary outcomes:
measure: For the patient: Change in Modified Rankin Scale (MRS)
timeFrame: Change from baseline to week 22; change from week 22 to week 48
measure: For the patient: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
timeFrame: Change from baseline to week 22
measure: For the patient: Change in Berg Balance Scale (BBS)
timeFrame: Change from baseline to week 22
measure: For the patient: Change in Displacement of the Centre of Pressure (COP) while sitting through a force pad
timeFrame: Change from baseline to week 22
measure: For the patient: Change in Walking distance in two minutes (2-MWT)
timeFrame: Change from baseline to week 22
measure: For the patient: Changes in the Short Form Health Survey (SF-36) for quality
timeFrame: Change from baseline to week 22; change from week 22 to week 48
measure: For the caregiver: Change in Zarit Burden Inventory (ZBI)
timeFrame: Change from baseline to week 22
measure: For the caregiver: Changes in the Short Form Health Survey (SF-36) for quality of life
timeFrame: Change from baseline to week 22
Other outcomes:
Locations:
city: La Canourgue
country: France
facility: Institut Equiphoria
Study officials:
affiliation: Alliance Equiphoria
name: Manuel Gaviria, MD, PhD
role: STUDY_DIRECTOR
affiliation: Alliance Equiphoria - Institut Equiphoria
name: Hélène Viruega, ESMHL
role: STUDY_CHAIR
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