- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07802509
Does Hippotherapy Have an Effect on Mobility, Gait, Balance and Perceived Health-related Quality of Life in Persons With Parkinson's Disease? (HIHA)
The goal of this pilot randomized controlled trial is to investigate the effects of hippotherapy (horse assisted therapy) (intervention group) compared to usual care (control group) on mobility, gait, balance and perceived health-related quality of life in persons with Parkinson's disease. The main objectives of this study are:
- The primary objective is to investigate the effects of hippotherapy on mobility of pwPD, walking speed and the ability to perform daily movements.
- The secondary objective is to investigate the effects of hippotherapy on (a) balance, (b) self-perceived physical and mental health and (c) specific gait parameters.
- Furthermore this study, aims to gather critical information that will inform about the design and implementation of a larger, more definitive randomized controlled trial.
In addition to the three-week, multidisciplinary rehabilitation program the intervention group will receive hippotherapy (20 minutes) three times a week (7 sessions in total) and the control group will receive additional physiotherapy sessions (30 minutes) two times a week.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jens Bansi, PhD
- Phone Number: +41 58 511 13 02
- Email: jens.bansi@kliniken-valens.ch
Study Contact Backup
- Name: Isa Slotboom, MSc
- Phone Number: +41 58 511 13 73
- Email: isa.slotboom@kliniken-valens.ch
Study Locations
-
-
Canton of St. Gallen
-
Valens, Canton of St. Gallen, Switzerland, 7317
- Recruiting
- Rehabilitation Centre Valens
-
Principal Investigator:
- Jens Bansi, PhD
-
Contact:
- Jens Bansi, PhD
- Phone Number: +41 58 511 13 02
- Email: jens.bansi@kliniken-valens.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed diagnosis of Parkinson's diagnosis
- Age > 18 Years;
- Hoehn & Yahr stage ≤ 4;
- Category 3 in the Functional Ambulation Categories
- Climbing stairs is possible (with support).
Exclusion Criteria:
- Severe cognitive impairment, defined by a score below 26 on the Montreal Cognitive Assessment (MoCa)
- Body weight > 90kg;
- Horse hair allergy;
- Other acute and subacute cardiovascular, respiratory, musculoskeletal or neurological disorders that constitute a contraindication to hippotherapy (i.e. a recent fracture);
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hippotherapy
In addition to the three-week, multidisciplinary rehabilitation program the intervention group will receive hippotherapy three times a week (7 sessions in total).
The hippotherapy sessions last 20 minutes each and aim at trunk rotation (in the transverse and frontal plane), rhythm and trunk stability.
They will receive this in addition to the usual three-week rehabilitation program.
This program includes 30 minutes of physical therapy daily plus two additional physiotherapy sessions of 30 minutes, 30 minutes of occupational therapy 3x/week, strength training 3x/week, 45 minutes of balance training 2x/week and, as required, other therapies such as nutritional advice, speech therapy and/or creative therapy to meet the individual needs of people with Parkinson's.
|
Hippotherapy is a form of physical therapy that utilizes the natural gait and movement of a horse to provide motor and sensory input.
The hippotherapy sessions last 20 minutes each and aim at trunk rotation (in the transverse and frontal plane), rhythm and trunk stability.
Other Names:
|
|
Active Comparator: Usual care
The comparison group will perform the three-week rehabilitation program, without hippotherapy.
This program includes 30 minutes of physical therapy daily plus two additional physiotherapy sessions of 30 minutes, 30 minutes of occupational therapy 3x/week, strength training 3x/week, 45 minutes of balance training 2x/week and, as required, other therapies such as nutritional advice, speech therapy and/or creative therapy to meet the individual needs of people with Parkinson's.
|
Physiotherapy sessions take 30 minutes and focus on core stability and exercises with large motor tasks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional mobility.
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Functional mobility will be measured with the expanded Timed Up and Go test. The eTUG is a modification of the traditional Timed Up and Go test, whereby the distance is increased from 6 to 10m. This has enabled a more accurate gait assessment in pwPD. Multiple time points are assessed:
The more time someone takes to perform the test, the more the mobility is impaired. |
From enrollment to the end of treatment at 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Balance will be assessed with the Mini Balance Evaluation Systems Test (Mini-BESTest).
The Mini-BESTest is shorter, more clinically applicable version of the original Balance Evaluation Systems Test (BESTest).
This test focuses on subcomponents of balance control, such as anticipatory postural adjustments, postural responses, sensory orientation, and dynamic gait.
It has proven to be effective in detecting balance impairments in persons with Parkinsons disease.
The scale ranges from 0-28 points, with higher scores indicating better balance capacity.
|
From enrollment to the end of treatment at 3 weeks
|
|
Health related quality of life
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Health related quality of life will be assessed with the Patient-Reported Outcomes Measurement Information System Global Health Short Form v1.2 (PROMIS-GH-10).
The PROMIS-GH-10 is a ten-item questionnaire that assesses generic health related quality of life compared with normal values for the general population.
It measures five domains: physical function, fatigue, pain, emotional distress, and social health on a five-point response matrix.
Both physical and mental scores range from 0-20, with higher scores indicating a better perceived health related quality of life.
|
From enrollment to the end of treatment at 3 weeks
|
|
Walking capacity
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Walking capacity will be tested using the 6 minutes walking test (6-MWT).
With the 6-MWT, the total distance in meters covered within six minutes is assessed.
The 6-MWT is performed on a 20-meter hallway, on which participants are asked to walk back and forth at maximal speed for the duration of six minutes without permission of rest.
The instruction is standardized as "to walk at the fastest speed, and to cover as much distance as possible".
Participants are allowed to use a walking aid, if necessary to ensure safe ambulation.
The use of walking aids will be documented in the CRF, and participants are asked to use the same walking aid during the re-test at T1.
During the tests, the research assistant blinded to group allocation is instructed, to not encourage the participant.
The greater the distance walked during the test, the greater the walking endurance.
|
From enrollment to the end of treatment at 3 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Adherence rates will be obtained to help design and implement a larger scaled randomized controlled trial.
The therapist that is performing the hippotherapy or additional physiotherapy sessions with the participant will document the training in the CRF.
This includes reasons for not coming to the session (i.e.
no motivation, falling sick, etc), reasons for early termination of the training session (i.e.
fear, difficulty climbing on the horse) and a free space to write any other relevant information.
|
From enrollment to the end of treatment at 3 weeks
|
|
Recruitment rates
Time Frame: through study completion, approximately 2 years.
|
Recruitment rates will be obtained to gather information that will help to design and implement a larger scaled randomized controlled trial.
The research assistant that is responsible for recruitment will keep a list that keeps track of the date of recruitment / exclusion and reason of exclusion (i.e.
does not want to participate, does not meet the inclusion criteria).
|
through study completion, approximately 2 years.
|
|
Adverse effects.
Time Frame: From enrollment to the end of treatment at 3 weeks
|
Adverse effects concern the documentation of:
|
From enrollment to the end of treatment at 3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Parkinson Disease
- Therapeutics
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Animal Assisted Therapy
- Exercise Therapy
- Physical Therapy Modalities
- Equine-Assisted Therapy
Other Study ID Numbers
- Hippo-HIHA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.