Comparison of Embedded and Added Motor Imagery Training to Improve a Motor Skill in Patients After Stroke: a Pilot Randomised Controlled Trial Using a Mixed Methods Approach
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
研究概览
简要总结
The purpose of the study is to examine if patients in the embedded motor imagery (MI) training group (EG1) need less time to perform the motor task than patients in the added MI training group (EG2).
详细描述
The purpose of the study is to examine if patients in the embedded MI training into physiotherapy (EG1) need less time to perform the motor task than patients in the added MI training to physiotherapy (EG2).
A third groups serves a control group (CG) to investigate the effect of the intervention versus a group with a control intervention.
Additionally, semi-structured interviews before and after the intervention will give an insight in the patient's experience with motor imagery (MI), their expectations regarding the intervention and their opinions about MI after the intervention.
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
- Single (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
- •Patients after a first-ever ischemic or hemorrhagic stroke
- •Outpatients or leaving inpatients 3 months after stroke
- •Ability to stand with or without a cane for at least 30 sec on a normal hard floor
- •Ability to walk for 20 metres with or without a cane or an orthosis
- •MMSE with at least 20 points
- •Age older than 18 years
- •Signed written informed consent
排除标准
- •Joint replacements (knee, hip, shoulder)
- •Limiting pain in the upper or lower body
- •Limiting range of motion (ROM) in the hip, knee, ankle joint or toes
- •Body weight more than 90 kilograms
- •Compromised mental capacity to give written informed consent
研究组 & 干预措施
EG1: embedded MI
Experimental group 1:
Participants receive motor imagery (MI) training included in 45min physiotherapy, 3 times per week for 2 weeks.
干预措施: Motor imagery (MI) training (Other)
EG2: added MI
Experimental group 2:
Participants receive a 15 minutes motor imagery (MI) training added to a 30 min physiotherapy session, 3 times a week for two weeks.
干预措施: Motor imagery (MI) training (Other)
CG
Control group:
Participants receive a 15 min control intervention added to their 30 min physiotherapy session, 3 times a week for two weeks.
干预措施: Control intervention (Other)
结局指标
主要结局
Time in seconds to perform a motor task: "Going down, laying on the floor and getting up again."
时间窗: 2 weeks
次要结局
- Motor imagery ability measured with the kinesthetic and visual motor imagery questionnaire (KVIQ) and the 'Imaprax 1.1' software.(2 weeks)
- Further outcome measures: - Help needed to perform the task, scored on a 7-item scale (1 total help, 7 completely independent) - Stage of motor task (one out of 13 possible stages)(2 weeks)
- Balance measured with the Berg Balance Scale (BBS).(2 weeks)
- Motor impairment and independence measured with the extended Barthel index (EBI).(2 weeks)
- Fear of falling (FOF) is measured with the Activities-Specific Balance Confidence Scale (ABC-scale).(2 weeks)