Home-based Gait and Balance Training in Patients With Movement Disorders
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Gait and balance training.
- Кому может быть актуально
- Состояния в реестре: Ataxia, Parkinson Disease. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Two Home-based Gait and Balance Trainings With Different Training Frequencies in Patients With Parkinson's Disease and Ataxia
Обзор
The research project is an experimental study with three study visits at the study site at the University Hospital Düsseldorf (UKD) / Heinrich Heine University Düsseldorf (HHU) and a three-week training phase in a parallel design. Patients with movement disorders (ataxia or Parkinson\'s disease) can take part. The training phase includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. Two different training protocols are carried out in parallel for three weeks each: One with 20 minutes of training per day, four days per week; and one with a training duration of 40 minutes per day, only two days per week. All patients initially take part in a one-week familiarization phase without training and are then randomly assigned to one of the two training protocols or the control group without additional training. In both training phases, the total amount of weekly training time is the same, but the frequency and duration of training sessions per week differs. The patients who were assigned to the control group without additional training can complete the training after their third study visit.
Подробное описание
It will be investigated separately for the two patient groups (ataxia, Parkinsons disease), whether the video-based training can lead to an improvement in gait and balance and whether the training protocols differ with regard to the desired improvement. The gait and balance variables recorded using the two standard methods (force plate, motion capturing system) will serve as the basis for assessing the training effect. Furthermore, the investigators want to analyze how the individual variables differ between the healthy subjects (from our previous study) and patients with movement disorders.
Patients can also voluntarily record movement data using their own smartphone. This has the advantage that data can also be collected at home, which is more likely to reflect the everyday life of the participants. In particular, the aim is to check whether the data collected with the smartphone can also be read and analyzed in patients, despite the increased movement variability, and whether typical movement patterns and training-related changes can be recorded.
Only adults will take part in the study. The aim is to assess 21 patients with cerebellar ataxia or idiopathic Parkinsons disease per group. This number is based on a power calculation with the software G\*Power 3.1.9.7 (Test family t tests, Means: Difference between two independent means (two groups)), with one-sided significance with α = 0.05, 1-β = 0.8 and a calculated effect size of 0.8. Participants in the study will be fully informed in advance about the study procedure. Participation in the study is voluntary. Participants can withdraw from the study at any time without giving reasons and without any disadvantages. A clinical diagnosis of cerebellar ataxia or idiopathic Parkinsons disease is a prerequisite for participation in the study. Participants must also be able to walk independently for 2 minutes. Exclusion criteria are other diseases with an impact on motor skills or serious primary psychiatric illnesses, current drug or alcohol dependency, consumptive illnesses or a poor general condition. There must be no increased risk of falling. Parkinsons patients should carry out the measurements on site and at home during the on-phase of the medication, approx. 2 hours after taking the medication. Patients are recruited via the special outpatient clinic for movement disorders at the Institute for Movement Disorders and Neuromodulation at the UKD / HHU Düsseldorf.
The study is discontinued for the individual study participant if an increased risk of falls becomes apparent. The study as a whole will be discontinued if it becomes apparent that the risks of the study outweigh the benefits or if unforeseen complications arise during the training phase.
Вмешательства
- Другое Gait and balance training
The training includes individually adapted, targeted, video-based coordination and balance training, which should lead to an improvement in gait and balance. It includes strength, coordination and flexibility exercises.
Первичные конечные точки
- gait velocity [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
Вторичные конечные точки (12)
- stride time [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- step width [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- cadence [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- Lat Step Dev [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- Toe Out Angle [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- Double Support Time [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- Toe Off Angle [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- sway area [Срок оценки: rom enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- sway velocity [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- sway path [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- arm-pelvis distance [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
- foot elevation [Срок оценки: From enrollment to the end of intervention at 4 weeks (training groups) / at 7 weeks (control groups)]
Критерии участия
Критерии включения
- clinical diagnosis of cerebellar ataxia or idiopathic Parkinson's syndrome
- opportunity to walk a distance of four meters unhindered at home
Критерии исключения
- other diseases with an impact on motor skills
- severe primary psychiatric illnesses
- current drug or alcohol addiction
- consumptive diseases
- poor general condition
- increased risk of falling (anamnestic fall frequency of ≥ 1x per week or as assessed by the attending physician)
- incapacitated patients in official or court custody or patients unable to give consent
- for PD patients taking medication: not being able to carry out the measurement in the on-phase of the medication
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Германия · 1 центр
- Universitätsklinikum Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinisc — Düsseldorf
Публикации
- Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. PMID 17695343
- Miyai I, Ito M, Hattori N, Mihara M, Hatakenaka M, Yagura H, Sobue G, Nishizawa M; Cerebellar Ataxia Rehabilitation Trialists Collaboration. Cerebellar ataxia rehabilitation trial in degenerative cerebellar diseases. Neurorehabil Neural Repair. 2012 Jun;26(5):515-22. doi: 10.1177/1545968311425918. Epub 2011 Dec 2. PMID 22140200
Идентификаторы
NCT: NCT06617884 · 2022-1994