Идёт набор NCT04611009

Video-supervised Motor and Awareness Training in Writer's Cramp

Фаза II С лечением Writer's Cramp

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: motor training, mindfulness exercises.
Кому может быть актуально: Состояния в реестре: Writer's Cramp. Базовые параметры: 18 лет — 80 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

Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp

Обзор

Writer's cramp is the most common task-specific dystonia. It is characterized by involuntary co-contraction of antagonistic muscles during writing. This disabling condition may force patients to give up their occupation. In this study the efficacy of a twelve months long-term training in patients with writer's cramp will be investigated. Two different programs will be offered: The first one will consist of a sensorimotor, the second one of an awareness training. All patients will benefit from video-based supervision with the aim to establish a practice-oriented therapeutic approach that will be available to all patients independently of their home location. The treatment effect will be measured primary with the patient-centered Canadian Occupational Performance Measure (COPM) and secondary with clinical scales to assess the clinical efficacy and everyday constraints. Writing will be assessed with a computer-based kinematic writing analysis. To evaluate the influence on the brain network, several functional magnetic resonance imaging (fMRI) evaluations will be performed. This project is of minimal risk without negative side effects from the training. The risks for the MRI experiment are equal to a non-contrast standard MRI investigation.

Вмешательства

Поведенческое motor training
In the sensorimotor training program task-specific and non-task specific aspects will be combined. It will start with assignments to improve general finger and wrist movements. After four weeks more specific writing exercises will be added.
Поведенческое mindfulness exercises
The awareness training will contain mindfulness exercises. The goal is to consciously experience the here and now in sensual perception of oneself and the environment.

Первичные конечные точки

Canadian Occupational Performance Measure [Срок оценки: Change from baseline to month 4, 8, 12]

Вторичные конечные точки (6)

kinematic writing analysis [Срок оценки: Change from baseline to month 4, 8, 12]
Writer's Cramp Rating Scale [Срок оценки: Change from baseline to month 4, 8, 12]
writing during functional magnetic resonance imaging (fMRI) [Срок оценки: Change from baseline to month 4, 8, 12]
qualitative interviews [Срок оценки: Change from baseline to month 4, 12]
Arm Dystonia Disability Scale [Срок оценки: Change from baseline to month 4, 8, 12]
Serial Reaction Time Task during functional magnetic resonance imaging (fMRI) [Срок оценки: Change from baseline to month 4, 8, 12]

Критерии участия

Критерии включения

Right handed idiopathic WC according to standardized criteria (simple and complex WC, any dystonic posture (including flexion, extension, pronation, supination))
able to participate in video-calls

Критерии исключения

Additional neurological or psychiatric diseases
left-handed patients
last botulinum toxin treatment <3 months, remaining weakness from the last injection
concomitant use of anticholinergics or sedating medication

Exclusion criteria for MRI: