NCT05345886

Brief Summary

This study aims to explore the interest of hippotherapy in the management of patients with stroke in the sequelae phase by evaluating the psychological and physical well-being. It is a controlled and randomized prospective longitudinal study. Hippotherapy is a rehabilitation method entrusted to a paramedical or medical profession that uses the horse in its treatment program in addition to conventional medical care. Hippotherapy has benefits at the psychomotor and motor level. The method is based on the use of the horse's characteristic movements when walking to provide sensory information and to induce motor adjustment responses mainly at the level of the pelvis and the trunk of the rider in order to work on balance, postural control, muscle tone and joint mobility of the patient sitting on his back. In particular for people with paresis or plegia sequelae, it contributes to rehabilitation programs. In addition, by inducing a helical movement of the pelvis, the horse's walk reproduces in the the disabled rider a pattern of trunk reactions very similar to that of the normal human walking pattern. This pattern can be integrated as a normal sensorimotor reaction and help the patient to improve his sitting balance and his coordination. Hippotherapy is also interesting because getting out of the traditional rehabilitation framework and being in contact with an imposing animal has positive repercussions on the psyche and therefore on functional recovery. All patients will undergo an assessment that will focus on their physical and psychological well-being at the beginning and end of the study as well as during a follow-up at 2 weeks, one month and 3 months. Patients assigned to the experimental group (EG) will receive, in addition to their physical therapy, a weekly hippotherapy session of 30 minutes. The follow-up will take place during 3 months for a total of 12 sessions. The EG will also be monitored in the short term (before and after each session) for well-being and fatigue. Quality of life will be explored using the SF-36 questionnaire and the SS-QOL scale. Self-esteem will be measured using the Rosenberg scale. Patients' physical abilities will be assessed with functional tests, standing balance measurements on a strength platform and the ABC-S self-evaluation scale.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2022

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

April 6, 2022

Last Update Submit

July 27, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • The stroke specific quality of life (SS-QOL)

    The SS-QOL, which is a disease-specific quality of life measure, consists of 49 items encompassing 12 domains, which include the social role (five questions), mobility (six questions), energy (three questions), language (five questions), self-care (five questions), mood (five questions), personality (three questions), thinking (three questions), upper extremity function (five questions), family role (three questions), vision (three questions), and work/productivity (three questions). Each item is ranked on a five-point Likert scale in which level one means completely agreed while level five means completely disagree. The summary score of this scale is an un-weighted average of the 12 domains. The total score ranges from 49 to 245, with higher scores indicating a better QOL. Scale

    12 weeks

  • 36-Item Short Form Survey Instrument (SF-36)

    The Short Form 36 Health Survey Questionnaire (SF-36) is used to indicate the health status of particular populations, to help with service planning and to measure the impact of clinical and social interventions. It is composed of 8 domains assessing quality of life which enable to obtain two composite scores. Higher scores correspond to a higher quality of life.

    12 weeks

Secondary Outcomes (7)

  • Rosenberg self-esteem scale

    12 weeks

  • Timed up & go

    12 weeks

  • The Tinetti test

    12 weeks

  • Timed chair stand test

    12 weeks

  • Strength platform

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Hippotherapy

EXPERIMENTAL

The experimental group will receive 30 minutes of hippotherapy once a week for 12 weeks.

Behavioral: Hippotherapy

Control

NO INTERVENTION

The control group will receive its rehabilitation care

Interventions

HippotherapyBEHAVIORAL

Hippotherapy is a rehabilitation method entrusted to a paramedic or medical practitioner who uses the horse in his/her program treatment, in addition to conventional medical care.

Hippotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have suffered a stroke and who are in a sequelae phase (after hospitalization or discharge from the rehabilitation center)
  • patients who have sufficient trunk balance to hold on to the horse
  • patients who have the consent of their doctor
  • patients who indicated their agreement to participate in the study by signing the consent form

You may not qualify if:

  • pressure sore at the seat level
  • other lesion or neurological history
  • severe cognitive deficits affecting the understanding
  • do not understand French language
  • allergy to horses
  • weigh more than 100 kg
  • acute pain syndrome
  • epilepsy
  • patient has benefited from hippotherapy sessions during the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CNRF

Tinlot, Liège, 4557, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Helena Cassol, PhD

CONTACT

Marie Vanderthommen, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 26, 2022

Study Start

May 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2025

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations