Evaluation of Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal Transcutaneous Electrical Stimulation, Through a Garment With built-in Electrodes in Combination With Training.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Goal attainment scaling (GAS)
研究概览
简要总结
Spasticity is a common consequence of injury to the central nervous system and can be a major problem in motor function and everyday activities. A method for treating spasticity that applies low-amplitude electrical stimulation through a garment with built-in electrodes, Mollii® (Elektrodress), has been developed. The garment is to be used in combination with individualized training and the stimulation is mainly given to antagonists of spastic muscles.
The general objective of this study is to evaluate the efficacy of and costs associated with the Mollii® treatment of spasticity due to stroke or cerebral palsy.
Primary objectives are;
- to study whether treatment with the Mollii® improves function and activity
- to evaluate the cost-effectiveness of the treatment, from both a health-care perspective and a societal perspective.
Secondary objectives are;
- to study whether there are differences in treatment effect between the stroke and the Cerebral Palsy groups in a subgroup-analysis
- to assess compliance with treatment
- to report any adverse effects.
详细描述
This study is designed as a double-blinded, randomized, cross-over trial (RCT). This part of the study takes 12 weeks (6 weeks of active treatment and 6 weeks of non-active treatment) and is followed by a wash-out period of 6 weeks. An uncontrolled,open phase starts after week 18, where patients are followed one year after inclusion.
30 participants with spasticity due to Stroke and Cerebral Palsy will be included.
Two centers are recruiting participants and are collecting data.
Outcome measures are chosen to reflect the different dimensions in the International Classification of Functioning, Disability and Health (ICF) and patient reported outcome measures (PROM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spasticity due to stroke or Cerebral Palsy
- •Have some preserved walking ability, with or without walking aids
- •Be able to understand the treatment and instruments/interviews used
- •For stroke participants, two years should have elapsed since their injury/insult
排除标准
- •Electronic devices
- •Ventriculoperitoneal shunt
- •Arrhythmia
- •Hearth infarction or unstable angina pectoris
- •Symptomatic hyper- or hypotonia
- •Cancer under treatment
- •Unstable psychiatric disease
- •Lung disease, affecting daily life
- •Unstable epileptic disease
- •Orthopedic surgery last year
- •Obesity with BMI > 35
- •Infectious disease with longstanding treatment
- •Pregnancy
结局指标
主要结局
Goal attainment scaling (GAS)
时间窗: 12 weeks
1 to 3 goals are defined and evaluated using the original GAS scale by Kiresuk
Arm-hand ability (ARAT + WMFT tasks 1&2)
时间窗: 12 weeks
Action Research Arm Test (ARAT)measuring grasp, grip, pinch and gross movement and this is complemented by Wolf Motor Function Test (WMFT) tasks 1 and 2 measuring active shoulder abduction
Mobility
时间窗: 12 weeks
10 meter walking test, divided into comfortable gait test (CGT) and fast gait test (FGT). Outcome is velocity, cadence and stride length. Timed Up \& Go (TUG)
次要结局
- Health related Quality of Life/QALY(Baseline, week 6, 12, 18, 52)
- Goal Attainment Scaling (GAS)(52 weeks)
- Self reported pain and spasticity(Baseline, week 6, 12, 18, 52)
- Muscle hypertonicity (Spasticity)(Baseline, week 6, 12, 18, 52)
- Range of Motion(Baseline, week 6, 12, 18, 52)
- Mobility(52 weeks)
- Costs(Baseline, week 6, 12, 18, 52)
- Arm-hand ability (ARAT + WMFT tasks 1&2)(52 weeks)
研究者
Per Ertzgaard
M.D.
Linkoeping University