Dose-Finding of Lower Limb Mirror Therapy After Stroke.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Changes in the Motricity Index
研究概览
简要总结
This study will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. The design is a 3+3 rule based, dose- finding study. Each cohort will consist of three participants. The first cohort will be assigned to do a dose of 15 minutes each day for two weeks. The second and subsequent cohorts will exercise at target dose set accordance to the nine preset rules and the modified Fibonacci sequence (mFBS).The study will continue until the stopping rule is triggered. The last dose tested will be identified as the maximum tolerable dose per day.
详细描述
Procedure:a 3+3 rule-based, dose-escalation design (Colucci et al,2017). recruitment process: the study will begin with a cohort of three participants (n=3). Each of the subsequent cohorts will also be of three participants. The start dose will be set at 15 minutes (cohort one). Participants will do ankle dorsiflexion exercise at the set dose with the mirror for two weeks. The second and subsequent cohorts will exercise at dose set in accordance to the nine preset rules and the modified Fibonacci sequence (mFBS) .
Sample size: The target sample size is not usually predefined for a dose-finding study. The final sample size will be determined by the response of consecutive cohorts to the set dose. Usually, in pharmaceutical dose-finding studies, the sample size lies between 12 and 40.
Data analysis : The data for each cohort will be analysed using descriptive statistics. No significance testing is involved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants have had a stroke for six weeks or more before recruitment to this study, and are discharged from NHS statutory stroke rehabilitation.
- •Participants will be at least 18 years of age
- •Able to produce some voluntary contraction of paretic ankle ( motricity index between 9 and 19).
- •Ability to understand and follow simple verbal instructions (one-stage commands), i.e. sufficient communication, orientation, and memory to participate in mirror therapy ankle exercise.
- •Participants will have had no lower limb injury in the last six months and were able to walk independently indoors before the index stroke.
排除标准
- •Foot or ankle contracture that prevents 50% of the passive range of motion.
- •Any condition that can be exaggerated by performing the therapy.
研究组 & 干预措施
mirror therapy
lower limb mirror therapy using ankle exercise
干预措施: rehabilitation intervention (Other)
结局指标
主要结局
Changes in the Motricity Index
时间窗: Baseline, 2 weeks.
次要结局
- Changes in the Neural excitability(Baseline, 2 weeks)
- Changes in the Symmetry(Baseline, 2 weeks)
- changes in the Transcranial magnetic stimulation (TMS)(Baseline, 2 weeks)