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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Institut Equiphoria
RECRUITING
La Canourgue
Contact Information
Primary
Manuel Gaviria, MD, PhD
manuel.gaviria@equiphoria.com
+33466321046
Backup
Didier Smadja, MD, PhD
didier.smadja@chsf.fr
Time Frame
Start Date: 2022-04-27
Estimated Completion Date: 2026-03
Participants
Target number of participants: 52
Treatments
Active_comparator: Hippotherapy treated group
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.
Placebo_comparator: Conventional neurorehabilitation treated group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Boehringer Ingelheim, Centre Hospitalier de Béziers, Centre Hospitalier Sud Francilien, University Hospital, Grenoble
Leads: Alliance Equiphoria

This content was sourced from clinicaltrials.gov