Stroke.
Graeme J Hankey
https://pubmed.ncbi.nlm.nih.gov/27637676Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04759326
Neurorehabilitation Through Hippotherapy on Neurofunctional Sequelae of Brain Stroke: Impact on Patient's Functional Independence, Sensorimotor and Cognitive Capacities, Quality of Life, and Caregivers' Quality of Life
Led by Alliance Equiphoria · Updated on 2024-07-31
52
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
Alliance Equiphoria
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
Stroke, also known as cerebrovascular accident (CVA), is a leading cause of disability worldwide, with many survivors left with lasting impairments. This research evaluates the effects of hippotherapy, a specialized rehabilitation using horse movement, on patients recovering from stroke, particularly those with moderate disability (Rankin score 3 or higher). The study also aims to assess how this therapy impacts the quality of life for caregivers. The trial compares hippotherapy to conventional outpatient rehabilitation during the recovery phase after hospital discharge. Participants in the study are divided into two groups. One group undergoes a hippotherapy program lasting 22 weeks, including three cycles: a 2-week initial cycle with daily one-hour sessions, followed by a 9-week rest period, then a 1-week daily session cycle, another 9-week rest, and a final 1-week daily session cycle. During rest periods, patients continue their usual outpatient neurorehabilitation. The control group receives standard outpatient rehabilitation such as physiotherapy, occupational therapy, language therapy, and psychological support throughout the program duration. Throughout the study, patients will undergo various clinical tests to measure functional independence, sensorimotor skills, cognitive abilities, stroke severity, and quality of life. Caregivers' burden and quality of life will also be evaluated. The primary outcome focuses on changes in the Functional Independence Measure from baseline to week 22 and up to week 48. Secondary outcomes include assessments like the Modified Rankin Scale, motor recovery evaluations, balance tests, walking distance, and health surveys. The study lasts 48 weeks, including follow-up periods to monitor sustained effects.
CONDITIONS
Brief Title
Neurorehabilitation Through Hippotherapy of a Brain Stroke
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ischemic or hemorrhagic stroke diagnosed according to ICD 10 I61-I69
- Stroke occurred more than 3 months before inclusion
- Moderate disability with Rankin score between 3 and 4 at inclusion
- Informed consent provided
- Affiliated with a social security scheme
- Minimal bilateral hip abduction of 25 degrees with no history of hip dislocation or dysplasia
- Medical certificate confirming no contraindications to participation
You will not qualify if you...
- Major cognitive impairment affecting understanding (Mini Mental State Examination score below 24)
- Presence of global or sensory aphasia
- Neurological or psychiatric conditions other than mild-to-moderate post-stroke depression
- Uncontrolled seizure disorders
- Substance abuse
- History of uncontrolled pain
- Allergic reactions to dust or horsehair, or severe asthma
- Body weight equal to or greater than 110 kg
- Contraindications to physical activity
- Inability or medical reasons preventing travel to the treatment center by personal car or taxi
- Participation in horse riding or hippotherapy in the past 6 months
- Pregnant or breastfeeding women
- Participation in other biomedical research studies or within exclusion periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 22 weeks
Participants receive neurorehabilitation either through hippotherapy or conventional outpatient rehabilitation to support recovery of functional independence, sensorimotor and cognitive capacities, and quality of life.
Daily sessions for 2 weeks, then daily sessions for 1 week after a 9-week break, followed by another 1-week daily session after a second 9-week break
Follow-up
Duration - 26 weeks
Participants are monitored after treatment ends to assess long-term changes in functional independence, motor recovery, and quality of life.
Visits at weeks 22 and 48
Trial Site Locations
Total: 1 location
1
Institut Equiphoria
La Canourgue, France, 48500
Actively Recruiting
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Research Team
M
Manuel Gaviria, MD, PhD
D
Didier Smadja, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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