Cerebrovascular AccidentHippoPostCVANCT04759326
Neurorehabilitation Through Hippotherapy of a Brain Stroke
A study testing Hippotherapy and Conventional Neurorehabilitation in people with Cerebrovascular Accident and Neurorehabilitation, run by Alliance Equiphoria at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Neurorehabilitation, Neuroplasticity
- What is being tested?
- Hippotherapy and Conventional Neurorehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2022to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 (30)
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Didier Smadja, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
Institut Equiphoria
La Canourgue, 48500
Manuel Gaviria, MD, PhD, manuel.gaviria@equiphoria.com
Hélène Viruega, ESMHL, helene.viruega@equiphoria.com
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Cerebrovascular Accident, Neurorehabilitation, Neuroplasticity, Hippotherapy, Silent Neurofunctional Barriers, Functional Deficit
- Being tested
- Hippotherapy, Conventional Neurorehabilitation
- Keywords
- NeuroRehabilitation through hippotherapy, Brain plasticity, Functional recovery
- Medical subject headings
- Stroke, Cognition Disorders, Psychological Trauma, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HippotherapyOther
Hippotherapy 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 NeurorehabilitationOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Hippotherapy treated group | Active comparator | The hippotherapy protocol will comprise three cycles. The first one consists of one session per day for 2 weeks allowing (i) to evaluate the patient and his neuro-functional skills, and (ii) to determine and carry out the treatment taking into account the silent barriers that may exist (PSTD, fatigue, pain, fear...) and strongly interfere with functional outcome (developing ways to overcome them). After a 9-week 'wash out' period (during which the patient consolidates the new patterns, translates them into daily activities and identifies new needs) where the patient continues his or her outpatient neurorehabilitation care, a further intermediate 1-week daily capacity building hippotherapy cycle follows. Then, after a second 9-week 'wash out' period (where the patient once again consolidates the new patterns, translates them into daily activities and identifies new needs), a final 1-week daily capacity building hippotherapy cycle will be carried out. Protocol will last 22 weeks. Receives: Other: Hippotherapy |
| Conventional neurorehabilitation treated group | Placebo comparator | Patients in the control group will receive standard outpatient rehabilitation treatment consisting of a program of physiotherapy (motor training, functional training), occupational therapy, language therapy, psychological and social support per week corresponding to the four weeks in which the treated group will be in hippotherapy. For the remaining 18 weeks, the treatment options for each patient, regardless of the group, will also include physiotherapy (motor training, functional training), occupational therapy, language therapy, psychological and social support. Receives: Other: Conventional Neurorehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to week 22; change from week 22 to week 48
Secondary outcomes (8)
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).
Measured: Change from baseline to week 22; change from week 22 to week 48
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.
Measured: Change from baseline to week 22
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.
Measured: Change from baseline to week 22
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.
Measured: Change from baseline to week 22
For the patient: Change in Walking distance in two minutes (2-MWT)
2-MWT is a functional walking test in which the distance that a client can walk within two minutes is evaluated. This test has been used to assess individuals with stroke. It is a valid measure of self-selected walking speed and the most time efficient walking test (compared to 6-MWT and 12-MWT). Distance walked, and the number and duration of rests during the 2 minutes should be measured. Scores range from 0 meters or feet for patients who are non-ambulatory to the maximum biological limits for normal healthy individuals.
Measured: Change from baseline to week 22
For the patient: Changes in the Short Form Health Survey (SF-36) for quality
SF-36 is a 36-item questionnaire which measures Quality of Life (QoL) across eight domains. The eight domains that the SF36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. The recommended scoring system for the SF-36 is a weighted Likert system for each item. Items within subscales are totalled to provide a summed score for each subscale or dimension. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale.
Measured: Change from baseline to week 22; change from week 22 to week 48
For the caregiver: Change in Zarit Burden Inventory (ZBI)
ZBI is one of the most commonly used instruments to assess caregiving burden in clinical and research settings. The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). The higher the score, the more extensive the burden. It can be self-administered or administered by a third party without training.
Measured: Change from baseline to week 22
For the caregiver: Changes in the Short Form Health Survey (SF-36) for quality of life
SF-36 is a 36-item questionnaire which measures Quality of Life (QoL) across eight
Measured: Change from baseline to week 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start27 Apr 2022
- Primary completionNov 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance Equiphoria
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Centre Hospitalier Sud Francilien, Centre Hospitalier de Béziers, University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Manuel Gaviria, MD, PhD, Study director, Alliance EquiphoriaHélène Viruega, ESMHL, Study chair, Alliance Equiphoria - Institut Equiphoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759326
- Sponsor's protocol ID
- 2020-A03172-37
- Acronym
- HippoPostCVA
- Status last verified
- Jul 2024
- First submitted
- 15 Feb 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dissemination of study results will be done through a classic strategy for publications (reports, scientific publications) and communications (congresses, meetings). The coordinator will be in charge of the dissemination strategy. Controlled access to the final trial dataset will be given when a reasonable request has a precise and valid scientific aim. Thus, we will protect the rights of patients and the intellectual property of the scientists who designed the trial and collected the data.
Publications
Hankey GJ. Stroke. Lancet. 2017 Feb 11;389(10069):641-654. doi: 10.1016/S0140-6736(16)30962-X. Epub 2016 Sep 13.
PubMed 27637676Luengo-Fernandez R, Paul NL, Gray AM, Pendlebury ST, Bull LM, Welch SJ, Cuthbertson FC, Rothwell PM; Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke. 2013 Oct;44(10):2854-61. doi: 10.1161/STROKEAHA.113.001584. Epub 2013 Aug 6.
PubMed 23920019Rice D, Janzen S, McIntyre A, Vermeer J, Britt E, Teasell R. Comprehensive Outpatient Rehabilitation Program: Hospital-Based Stroke Outpatient Rehabilitation. J Stroke Cerebrovasc Dis. 2016 May;25(5):1158-1164. doi: 10.1016/j.jstrokecerebrovasdis.2016.02.007. Epub 2016 Feb 28.
PubMed 26935115Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297.
PubMed 15562409Dobkin BH. Neurobiology of rehabilitation. Ann N Y Acad Sci. 2004 Dec;1038:148-70. doi: 10.1196/annals.1315.024.
PubMed 15838110Raineteau O, Schwab ME. Plasticity of motor systems after incomplete spinal cord injury. Nat Rev Neurosci. 2001 Apr;2(4):263-73. doi: 10.1038/35067570.
PubMed 11283749Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
PubMed 20400552Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036.
PubMed 21621674Combs SA, Dugan EL, Passmore M, Riesner C, Whipker D, Yingling E, Curtis AB. Balance, balance confidence, and health-related quality of life in persons with chronic stroke after body weight-supported treadmill training. Arch Phys Med Rehabil. 2010 Dec;91(12):1914-9. doi: 10.1016/j.apmr.2010.08.025.
PubMed 21112434Viruega H, Gaillard I, Briatte L, Gaviria M. Inter-Day Reliability and Changes of Surface Electromyography on Two Postural Muscles Throughout 12 Weeks of Hippotherapy on Patients with Cerebral Palsy: A Pilot Study. Brain Sci. 2020 May 6;10(5):281. doi: 10.3390/brainsci10050281.
PubMed 32384678Viruega H, Gaillard I, Carr J, Greenwood B, Gaviria M. Short- and Mid-Term Improvement of Postural Balance after a Neurorehabilitation Program via Hippotherapy in Patients with Sensorimotor Impairment after Cerebral Palsy: A Preliminary Kinetic Approach. Brain Sci. 2019 Sep 29;9(10):261. doi: 10.3390/brainsci9100261.
PubMed 31569505Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.
PubMed 7678184Rannikmae K, Woodfield R, Anderson CS, Charidimou A, Chiewvit P, Greenberg SM, Jeng JS, Meretoja A, Palm F, Putaala J, Rinkel GJ, Rosand J, Rost NS, Strbian D, Tatlisumak T, Tsai CF, Wermer MJ, Werring D, Yeh SJ, Al-Shahi Salman R, Sudlow CL. Reliability of intracerebral hemorrhage classification systems: A systematic review. Int J Stroke. 2016 Aug;11(6):626-36. doi: 10.1177/1747493016641962. Epub 2016 Apr 18.
PubMed 27091144Leys D, Ringelstein EB, Kaste M, Hacke W; Executive Committee of the European Stroke Initiative. Facilities available in European hospitals treating stroke patients. Stroke. 2007 Nov;38(11):2985-91. doi: 10.1161/STROKEAHA.107.487967. Epub 2007 Sep 27.
PubMed 17901388Wissel J, Olver J, Sunnerhagen KS. Navigating the poststroke continuum of care. J Stroke Cerebrovasc Dis. 2013 Jan;22(1):1-8. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.021. Epub 2011 Jul 5.
PubMed 21733720
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04759326
- Acronym / sponsor ID
- HippoPostCVA / 2020-A03172-37
- Conditions
- Cerebrovascular Accident, Neurorehabilitation, Neuroplasticity, Hippotherapy, Silent Neurofunctional Barriers, Functional Deficit
- Keywords
- NeuroRehabilitation through hippotherapy, Brain plasticity, Functional recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Alliance EquiphoriaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Centre Hospitalier Sud Francilien, Centre Hospitalier de Béziers, University Hospital, Grenoble
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy treated group | Active comparator | Other: HippotherapyThe hippotherapy protocol will comprise three cycles. The first one consists of one session per day for 2 weeks allowing (i) to evaluate the patient and his neuro-functional skills, and (ii) to determine and carry out the treatment taking into account the silent barriers that may exist (PSTD, fatigue, pain, fear...) and strongly interfere with functional outcome (developing ways to overcome them). After a 9-week 'wash out' period (during which the patient consolidates the new patterns, translates them into daily activities and identifies new needs) where the patient continues his or her outpatient neurorehabilitation care, a further intermediate 1-week daily capacity building hippotherapy cycle follows. Then, after a second 9-week 'wash out' period (where the patient once again consolidates the new patterns, translates them into daily activities and identifies new needs), a final 1-week daily capacity building hippotherapy cycle will be carried out. Protocol will last 22 weeks. |
| Conventional neurorehabilitation treated group | Placebo comparator | Other: Conventional NeurorehabilitationPatients in the control group will receive standard outpatient rehabilitation treatment consisting of a program of physiotherapy (motor training, functional training), occupational therapy, language therapy, psychological and social support per week corresponding to the four weeks in which the treated group will be in hippotherapy. For the remaining 18 weeks, the treatment options for each patient, regardless of the group, will also include physiotherapy (motor training, functional training), occupational therapy, language therapy, psychological and social support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 (30)
- Deficit still existing (Rankin score ≥ 3 and ≤ 4 at inclusion)
- Existing declaration of informed consent
- Affiliation of the patient to a social security scheme
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HippotherapyHippotherapy 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. | Other | Hippotherapy treated group |
| Conventional NeurorehabilitationThe 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. | Other | Conventional neurorehabilitation treated group |
Primary outcome
For the patient: Change in Functional Independence Measure (FIM)
Time frame: Change from baseline to week 22; change from week 22 to week 48
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.
8 secondary outcomes
For the patient: Change in Modified Rankin Scale (MRS)
Time frame: Change from baseline to week 22; change from week 22 to week 48
For the patient: Change in Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
Time frame: Change from baseline to week 22
For the patient: Change in Berg Balance Scale (BBS)
Time frame: Change from baseline to week 22
For the patient: Change in Displacement of the Centre of Pressure (COP) while sitting through a force pad
Time frame: Change from baseline to week 22
For the patient: Change in Walking distance in two minutes (2-MWT)
Time frame: Change from baseline to week 22
For the patient: Changes in the Short Form Health Survey (SF-36) for quality
Time frame: Change from baseline to week 22; change from week 22 to week 48
For the caregiver: Change in Zarit Burden Inventory (ZBI)
Time frame: Change from baseline to week 22
For the caregiver: Changes in the Short Form Health Survey (SF-36) for quality of life
Time frame: Change from baseline to week 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 27637676Hankey GJ. Stroke. Lancet. 2017 Feb 11;389(10069):641-654. doi: 10.1016/S0140-6736(16)30962-X. Epub 2016 Sep 13.
- Background: PubMed 23920019Luengo-Fernandez R, Paul NL, Gray AM, Pendlebury ST, Bull LM, Welch SJ, Cuthbertson FC, Rothwell PM; Oxford Vascular Study. Population-based study of disability and institutionalization after transient ischemic attack and stroke: 10-year results of the Oxford Vascular Study. Stroke. 2013 Oct;44(10):2854-61. doi: 10.1161/STROKEAHA.113.001584. Epub 2013 Aug 6.
- Background: PubMed 26935115Rice D, Janzen S, McIntyre A, Vermeer J, Britt E, Teasell R. Comprehensive Outpatient Rehabilitation Program: Hospital-Based Stroke Outpatient Rehabilitation. J Stroke Cerebrovasc Dis. 2016 May;25(5):1158-1164. doi: 10.1016/j.jstrokecerebrovasdis.2016.02.007. Epub 2016 Feb 28.
- Background: PubMed 15562409Staudt M, Gerloff C, Grodd W, Holthausen H, Niemann G, Krageloh-Mann I. Reorganization in congenital hemiparesis acquired at different gestational ages. Ann Neurol. 2004 Dec;56(6):854-63. doi: 10.1002/ana.20297.
- Background: PubMed 15838110Dobkin BH. Neurobiology of rehabilitation. Ann N Y Acad Sci. 2004 Dec;1038:148-70. doi: 10.1196/annals.1315.024.
- Background: PubMed 11283749Raineteau O, Schwab ME. Plasticity of motor systems after incomplete spinal cord injury. Nat Rev Neurosci. 2001 Apr;2(4):263-73. doi: 10.1038/35067570.
- Background: PubMed 20400552Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
- Background: PubMed 21621674Shi YX, Tian JH, Yang KH, Zhao Y. Modified constraint-induced movement therapy versus traditional rehabilitation in patients with upper-extremity dysfunction after stroke: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2011 Jun;92(6):972-82. doi: 10.1016/j.apmr.2010.12.036.
- Background: PubMed 21112434Combs SA, Dugan EL, Passmore M, Riesner C, Whipker D, Yingling E, Curtis AB. Balance, balance confidence, and health-related quality of life in persons with chronic stroke after body weight-supported treadmill training. Arch Phys Med Rehabil. 2010 Dec;91(12):1914-9. doi: 10.1016/j.apmr.2010.08.025.
- Background: PubMed 32384678Viruega H, Gaillard I, Briatte L, Gaviria M. Inter-Day Reliability and Changes of Surface Electromyography on Two Postural Muscles Throughout 12 Weeks of Hippotherapy on Patients with Cerebral Palsy: A Pilot Study. Brain Sci. 2020 May 6;10(5):281. doi: 10.3390/brainsci10050281.
- Background: PubMed 31569505Viruega H, Gaillard I, Carr J, Greenwood B, Gaviria M. Short- and Mid-Term Improvement of Postural Balance after a Neurorehabilitation Program via Hippotherapy in Patients with Sensorimotor Impairment after Cerebral Palsy: A Preliminary Kinetic Approach. Brain Sci. 2019 Sep 29;9(10):261. doi: 10.3390/brainsci9100261.
- Background: PubMed 7678184Adams HP Jr, Bendixen BH, Kappelle LJ, Biller J, Love BB, Gordon DL, Marsh EE 3rd. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993 Jan;24(1):35-41. doi: 10.1161/01.str.24.1.35.
- Individual participant dataSharing planned: No. Dissemination of study results will be done through a classic strategy for publications (reports, scientific publications) and communications (congresses, meetings). The coordinator will be in charge of the dissemination strategy. Controlled access to the final trial dataset will be given when a reasonable request has a precise and valid scientific aim. Thus, we will protect the rights of patients and the intellectual property of the scientists who designed the trial and collected the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Smadja, MD, PhD contact
Manuel Gaviria, MD, PhD study director
Alliance Equiphoria
Hélène Viruega, ESMHL study chair
Alliance Equiphoria - Institut Equiphoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hippotherapy and Conventional Neurorehabilitation in people with Cerebrovascular Accident and Neurorehabilitation, run by Alliance Equiphoria at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Gaviria, MD, PhD (+33466321046, manuel.gaviria@equiphoria.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For the patient: Change in Functional Independence Measure (FIM) (time frame: Change from baseline to week 22; change from week 22 to week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759326, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.