Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Canadian Occupational Performance Measure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded towards their participation in the two arms Clinical scales, kinematic writing anlysis and functional MRI will be analyzed by persons, who are blinded to the type of training group allocation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •Cardiac pacemaker, electronic or metal implants
- •pregnancy or suspected pregnancy
- •severe ametropia, anxiety in small rooms
研究组 & 干预措施
motor training
intervention: motor training
干预措施: motor training (Behavioral)
awareness training
intervention: mindfulness exercises
干预措施: mindfulness exercises (Behavioral)
结局指标
主要结局
Canadian Occupational Performance Measure
时间窗: Change from baseline to month 4, 8, 12
The Canadian Occupational Performance Measure will serve as the primary outcome measure. Patients grade their self-perceived performance and satisfaction of writing related occupations in daily life in respect to the goals they had identified and prioritized. The COPM ist patient centered end reflects the real life of the participants.
次要结局
- Arm Dystonia Disability Scale(Change from baseline to month 4, 8, 12)
- Writer's Cramp Rating Scale(Change from baseline to month 4, 8, 12)
- kinematic writing analysis(Change from baseline to month 4, 8, 12)
- writing during functional magnetic resonance imaging (fMRI)(Change from baseline to month 4, 8, 12)
- qualitative interviews(Change from baseline to month 4, 12)
- Serial Reaction Time Task during functional magnetic resonance imaging (fMRI)(Change from baseline to month 4, 8, 12)