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NCT Number: NCT07802509

DOES HIPPOTHERAPY HAVE AN EFFECT ON MOBILITY, GAIT, BALANCE AND PERCEIVED HEALTH-RELATED QUALITY OF LIFE IN PERSONS WITH PARKINSON'S DISEASE?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Centre Valens

Valens, Canton of St. Gallen, 7317, Switzerland

Location status: Recruiting

Location contact

Jens Bansi, PhD

CONTACT

[email protected]

+41 58 511 13 02

Jens Bansi, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hippotherapy

Other

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: Equine assisted therapy

Physiotherapy

Other

Physiotherapy sessions take 30 minutes and focus on core stability and exercises with large motor tasks

Other names: Exercise therapy, Physical therapy

Primary outcomes

  1. 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 time the person takes to get from a sitting to standing position.
    • The time the person takes to walk the first two meters (gait initiation)
    • The time the person takes to walk the remaining (gait 1)
    • The time the person takes to turn (turning)
    • The time the person takes to (gait 2)
    • The time the person takes to slow down, turn and sit down again

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Recruitment rates

    Time frame: Recruitment - Enrollement

    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).

  2. 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.

  3. Safety

    Time frame: From enrollment to the end of treatment at 3 weeks

    Safety outcomes concern the documentation of:

    • reasons for study withdrawal (drop-out),
    • reasons for incomplete session attendance (< 7 session)
    • reasons for session abortion
    • reasons for deviations from exercise prescription
    • sudden severe disease progression or falling sick (e.g., bacterial or viral infections) during the study (discontinuation criterion)

Study contacts

Contact information is provided by the study sponsor or research team.

Isa Slotboom, MSc

CONTACT

[email protected]

+41 58 511 13 73

Jens Bansi, PhD

CONTACT

[email protected]

+41 58 511 13 02

Sponsors and collaborators

Lead sponsor

Klinik Valens

Other

Collaborators

  • Schweizer Gruppe für Hippotherapie-K

Registry information

Acronym: HIHA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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