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Does Hippotherapy Have an Effect on Mobility, Gait, Balance and Perceived Health-related Quality of Life in Persons With Parkinson's Disease? (HIHA)

2026年9月14日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • スイス
    • Canton of St. Gallen
      • Valens、Canton of St. Gallen、スイス、7317
        • 募集
        • Rehabilitation Centre Valens
        • 主任研究者：
          • Jens Bansi, PhD
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：Hippotherapy
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.
他の名前：
  • Equine assisted therapy
アクティブコンパレータ：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.
他の：Physiotherapy
Physiotherapy sessions take 30 minutes and focus on core stability and exercises with large motor tasks
他の名前：
  • 運動療法
  • 理学療法

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Functional mobility.
時間枠：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

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Balance
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Adherence
時間枠：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
時間枠：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.
時間枠：From enrollment to the end of treatment at 3 weeks

Adverse effects 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)
From enrollment to the end of treatment at 3 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Klinik Valens

協力者

Schweizer Gruppe für Hippotherapie-K

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年1月1日

一次修了 (推定)

2027年1月1日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2026年8月31日

QC基準を満たした最初の提出物

2026年8月31日

最初の投稿 (実際)

2026年9月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17日

QC基準を満たした最後の更新が送信されました

2026年9月14日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Hippo-HIHA

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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