Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04759326

Neurorehabilitation Through Hippotherapy of a Brain Stroke

Led by Alliance Equiphoria · Updated on 2024-07-31

52

Participants Needed

1

Research Sites

200 weeks

Total Duration

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Sponsors

A

Alliance Equiphoria

Lead Sponsor

B

Boehringer Ingelheim

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neurorehabilitation Through Hippotherapy of a Brain Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 ago
  • Disability level with Rankin score between 3 and 4 at inclusion
  • Signed informed consent provided
  • Patient covered by a social security scheme
  • Ability to abduct hips at least 25 degrees bilaterally with no history of hip dislocation or dysplasia
  • Medical certificate confirming no contraindications to participate
Not Eligible

You will not qualify if you...

  • Major cognitive impairment affecting understanding (Mini Mental State Examination score below 24)
  • Global or sensory aphasia
  • Neurological or psychiatric disorders other than mild-to-moderate post-stroke depression
  • Uncontrolled seizure disorder
  • Substance abuse
  • History of uncontrolled pain
  • Allergic reactions to dust or horsehair, or severe asthma
  • Body weight 110 kg or more
  • Contraindications to physical activity
  • Unable or medically unfit to travel to the study center by personal car or taxi
  • History of horse riding or hippotherapy in the last 6 months
  • Pregnant or breastfeeding women
  • Participation in other biomedical research or under exclusion period

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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

CONTACT

D

Didier Smadja, MD, PhD

CONTACT

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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