Effect of Treatment Dairy on Botulinum Toxin Treatment for Muscle Overactivity (Spasticity). A Randomised Cross-over Study.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Patient becomes more satisfied with their treatment using the treatment diary
研究概览
简要总结
- Assessing whether the treatment diary can help optimize the overall treatment of patients.
- To assess whether the patient finds the treatment diary useful and worth spending time on. Also if the patient finds it easier to evaluate the treatment and, if necessary, set new goals.
- To assess whether the patient's quality of life is increased by the use of the treatment diary.
详细描述
Hypothesis
A treatment diary will increase the patient's awareness of which spasticity symptoms are significant and can enable the patients to evaluate the treatment more easily.
This will result in more relevant treatment goals. At the same time the treatment can be better addressed to the individual patient at routine controls. In addition, the treatment diary will result in closer cooperation between the physiotherapists and occupational therapists and the physician who administers the botulinum toxin. This collaboration is expected to lead to better common goals and optimization of treatment.
Finally, it is expected that the above will help to increase the patient's quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have received at least two previous treatments before inclusion, ie. with approx. 3 months apart, and it is assessed that the patients have good effect of the treatments in relation to the agreed treatment goals.
排除标准
- •Patients where changes are planned regarding their treatment for muscle overactivity during the study period.
- •Patients where the disease is not stable and where it may have a major influence on the treatment effect of botulinum toxin treatment during the study period and where it can be difficult to set SMART (Specific, Measurable, Accepted, Realistic, Timed) goals.
- •Patients who have previously been treated and have used a treatment diary in connection with the botulinum toxin treatment.
- •Patients who can not collaborate on completing goals and evaluating treatment effect due to language or cognitive problems.
- •Patients who at the same time are being treated with botulinum toxin in the bladder.
- •If significant changes occur in the patient's health, which may involve new cancer, stroke, multiple sclerosis attack, etc. during the study period, the participant will be withdrawn from the study.
结局指标
主要结局
Patient becomes more satisfied with their treatment using the treatment diary
时间窗: October 2019
To assess if the patient becomes more satisfied with their treatment using the treatment diary. This is assessed by a change in the score on the treatment assessment questionnaire (Questionnaire 1).
次要结局
- The patients' assessment of the treatment diary will be described (Questionnaire 3).(October 2019)
- To assess if the patient's quality of life is improved using the treatment diary.(October 2019)
研究者
Bo Biering-Soerensen
Doctor, Head of Clinic for spasticity
Rigshospitalet, Denmark