Does Hippotherapy Have an Effect on Mobility, Gait, Balance and Perceived Health-related Quality of Life in Persons With Parkinson's Disease? (HIHA)
2026년 9월 14일 업데이트: Jens Bansi, Klinik Valens
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.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jens Bansi, PhD
- 전화번호: +41 58 511 13 02
- 이메일: jens.bansi@kliniken-valens.ch
연구 연락처 백업
- 이름: Isa Slotboom, MSc
- 전화번호: +41 58 511 13 73
- 이메일: isa.slotboom@kliniken-valens.ch
연구 장소
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Canton of St. Gallen
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Valens, Canton of St. Gallen, 스위스, 7317
- 모병
- Rehabilitation Centre Valens
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수석 연구원:
- Jens Bansi, PhD
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연락하다:
- Jens Bansi, PhD
- 전화번호: +41 58 511 13 02
- 이메일: jens.bansi@kliniken-valens.ch
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
다른 이름들:
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활성 비교기: 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.
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Physiotherapy sessions take 30 minutes and focus on core stability and exercises with large motor tasks
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional mobility.
기간: From enrollment to the end of treatment at 3 weeks
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Balance
기간: From enrollment to the end of treatment at 3 weeks
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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.
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From enrollment to the end of treatment at 3 weeks
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Health related quality of life
기간: From enrollment to the end of treatment at 3 weeks
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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.
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From enrollment to the end of treatment at 3 weeks
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Walking capacity
기간: From enrollment to the end of treatment at 3 weeks
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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.
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From enrollment to the end of treatment at 3 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence
기간: From enrollment to the end of treatment at 3 weeks
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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.
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From enrollment to the end of treatment at 3 weeks
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Recruitment rates
기간: through study completion, approximately 2 years.
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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).
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through study completion, approximately 2 years.
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Adverse effects.
기간: From enrollment to the end of treatment at 3 weeks
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Adverse effects concern the documentation of:
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From enrollment to the end of treatment at 3 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 1월 1일
기본 완료 (추정된)
2027년 1월 1일
연구 완료 (추정된)
2027년 1월 1일
연구 등록 날짜
최초 제출
2026년 8월 31일
QC 기준을 충족하는 최초 제출
2026년 8월 31일
처음 게시됨 (실제)
2026년 9월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 14일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Hippo-HIHA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .