The Benefit of Hippotherapy in Stroke Patients
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hippotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CNRFRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hippotherapy
Control
Arm Description
The experimental group will receive 30 minutes of hippotherapy once a week for 12 weeks.
The control group will receive its rehabilitation care
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Rosenberg self-esteem scale
A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. A higher score corresponds to a higher self-esteem.
Timed up & go
At the signal from the assessor ("Go ahead"), the person should stand up and walk away.
a comfortable and safe speed up to a line drawn on the floor (3 m further), turn, then come back and sit down. A first attempt should be made to familiarize the person with the test. The test therefore comprises an exercise and subsequently an "official" test. Results: the investigator starts the timing at "Go ahead" and stops it when the person has returned to a seated position.
The time of the course (in seconds) is retained as the final score. The test will be judged positive (mobility disorders, risk of falling) if the score exceeds 12 to 14 seconds.
The Tinetti test
The Tinetti test was published by Mary Tinetti (Yale University) to assess the gait and balance in older adults and to assess perception of balance and stability during activities of daily living and fear of falling. It is also called Performance-Oriented Mobility Assessment (POMA). It also is a very good indicator of the fall risk of an individual. It has better test-retest, discriminative and predictive validities concerning fall risk than other tests including Timed Up and Go test (TUG), one-leg stand and functional reach test. The total score is 28. A total score below 26 indicates a problem. the lower the score, the bigger the problem. A score below 19 means that the risk of falling is multiplied by five.
Timed chair stand test
The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions.
Strength platform
Strength platform/Force plates are used to measure the efforts of activities such as walking or running. They deliver precise and reliable results for gait analysis, very useful in many fields such as research, rehabilitation, occupational therapy and fitting of prostheses.
The Activities-Specific Balance Confidence Scale (ABC Scale)
The ABC Scale is an 16 point self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Each item is ranked on a four-point Likert scale. A higher score corresponds to a higher level of confidence.
Well-being and fatigue
Well-being and fatigue will also be assessed using numerical scales ranging from 0 to 10, before and after each hippotherapy session. Higher scores indicate a lower level of well-being and a higher level of fatigue.
Full Information
NCT ID
NCT05345886
First Posted
April 6, 2022
Last Updated
July 27, 2022
Sponsor
Centre Hospitalier Universitaire de Liege
1. Study Identification
Unique Protocol Identification Number
NCT05345886
Brief Title
The Benefit of Hippotherapy in Stroke Patients
Official Title
The Benefit of Hippotherapy in the Therapeutic Management of Stroke Patients in Sequel Phase
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hippotherapy
Arm Type
Experimental
Arm Description
The experimental group will receive 30 minutes of hippotherapy once a week for 12 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive its rehabilitation care
Intervention Type
Behavioral
Intervention Name(s)
Hippotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The stroke specific quality of life (SS-QOL)
Description
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
Time Frame
12 weeks
Title
36-Item Short Form Survey Instrument (SF-36)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Rosenberg self-esteem scale
Description
A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. A higher score corresponds to a higher self-esteem.
Time Frame
12 weeks
Title
Timed up & go
Description
At the signal from the assessor ("Go ahead"), the person should stand up and walk away.
a comfortable and safe speed up to a line drawn on the floor (3 m further), turn, then come back and sit down. A first attempt should be made to familiarize the person with the test. The test therefore comprises an exercise and subsequently an "official" test. Results: the investigator starts the timing at "Go ahead" and stops it when the person has returned to a seated position.
The time of the course (in seconds) is retained as the final score. The test will be judged positive (mobility disorders, risk of falling) if the score exceeds 12 to 14 seconds.
Time Frame
12 weeks
Title
The Tinetti test
Description
The Tinetti test was published by Mary Tinetti (Yale University) to assess the gait and balance in older adults and to assess perception of balance and stability during activities of daily living and fear of falling. It is also called Performance-Oriented Mobility Assessment (POMA). It also is a very good indicator of the fall risk of an individual. It has better test-retest, discriminative and predictive validities concerning fall risk than other tests including Timed Up and Go test (TUG), one-leg stand and functional reach test. The total score is 28. A total score below 26 indicates a problem. the lower the score, the bigger the problem. A score below 19 means that the risk of falling is multiplied by five.
Time Frame
12 weeks
Title
Timed chair stand test
Description
The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions.
Time Frame
12 weeks
Title
Strength platform
Description
Strength platform/Force plates are used to measure the efforts of activities such as walking or running. They deliver precise and reliable results for gait analysis, very useful in many fields such as research, rehabilitation, occupational therapy and fitting of prostheses.
Time Frame
12 weeks
Title
The Activities-Specific Balance Confidence Scale (ABC Scale)
Description
The ABC Scale is an 16 point self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Each item is ranked on a four-point Likert scale. A higher score corresponds to a higher level of confidence.
Time Frame
12 weeks
Title
Well-being and fatigue
Description
Well-being and fatigue will also be assessed using numerical scales ranging from 0 to 10, before and after each hippotherapy session. Higher scores indicate a lower level of well-being and a higher level of fatigue.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Cassol, PhD
Phone
085519238
Ext
+32
Email
hcassol@chuliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Vanderthommen, MS
Phone
085519238
Ext
+32
Email
Marie.Vanderthommen@chuliege.be
Facility Information:
Facility Name
CNRF
City
Tinlot
State/Province
Liège
ZIP/Postal Code
4557
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Cassol, PhD
Phone
0475474128
Ext
+32
Email
hcassol@chuliege.be
First Name & Middle Initial & Last Name & Degree
Marie Vanderthommen, MS
Phone
085 51 91 11
Ext
+32
Email
marie.vanderthommen@chuliege.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Benefit of Hippotherapy in Stroke Patients
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