Robot-Enhanced Stroke Therapy Optimized Rehabilitation
试验速览
- 阶段
- 不适用
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer upper extremity motor function score (FMA)
研究概览
简要总结
The purpose of this study is to investigate two aspects of robotic therapy after stroke. One goal is to determine if early robotic rehabilitation of the upper limb (beginning 5-9 days post-stroke) is more effective than later robotic rehabilitation (beginning 21-25 days post-stroke). The other goal is to determine if higher intensity robotic rehabilitation (2 hours/day) is more effective than lower intensity robotic rehabilitation (1 hour/day).
详细描述
Medically stable stroke subjects will be recruited in the first few days following their stroke. All participants will complete clinical and robotic assessments of neurologic function at 7 time points. Therapy will occur daily (Monday through Friday) for 20 days.
Study participants will be randomly assigned to 1) start robot therapy early or late after stroke and 2)receive one or two hours of robot therapy per treatment day for four weeks, or 3) control group that will receive the current standard of care.
The participant's chart will be reviewed for information about their stroke and related health effects and medical treatments. Assessment points to track progress will occur at 7, 18, 31,44,90,180, and 365 days after a stroke for all groups (give or take 2 days to account for weekends and holidays).
Standard clinical assessments of neurologic function will be done at each assessment point and include: cognition, arm strength, muscle tone, spasticity, reflexes, dexterity, visual acuity and fields, the Behavioural Inattention Test, and tests of arm movement (Fugl-Meyer Upper-Extremity, Box and Block Test, Chedoke-McMaster Stroke Assessment, and the Action Research Arm Test). These assessments can usually be done in about an hour. The assessment may be done over two sessions if needed due to fatigue or scheduling conflicts.
Robotic therapy will be conducted using the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM, Bkin Technologies, Kingston, ON). It will include several different tasks, each designed to train aspects of sensorimotor function of the proximal upper limb. Task performance will be monitored and difficulty will increase within and between sessions. The majority of the investigator's methods have been used previously to achieve equivalent or superior outcomes to standard rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Recent first stroke (ischemic or hemorrhagic)
- •Upper extremity Fugl-Meyer score 15-45
- •Modified Ashworth score of shoulder/elbow less than or equal to 2
- •Able to follow task instructions
- •Visual acuity better than 20/50 in both eyes
- •Able to give consent
- •Able to commit to follow-up
排除标准
- •Prior stroke or significant neurologic problem (e.g. Multiple Sclerosis)
- •Pre-existing musculoskeletal injury that will interfere with active therapy
- •Pre-Stroke Modified Rankin Score > 2
- •Clinical evidence of Unilateral Spatial Neglect on the Behavioural Inattention Test (BIT)
- •Enrollment in a concurrent clinical intervention trial
- •Major co-morbid or concurrent illness such that improvement is unlikely or completion of the protocol as specified is unlikely
研究组 & 干预措施
Early Robotic Rehab Low Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive one hour of treatment per day for 20 days.
干预措施: Robotic exoskeleton (Device)
Early Robotic Rehab High Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.
干预措施: Robotic exoskeleton (Device)
Late Robotic Rehab Low Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive one hour of treatment per day for 20 days.
干预措施: Robotic exoskeleton (Device)
Late Robotic Rehab High Intensity
This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.
干预措施: Robotic exoskeleton (Device)
Control Group
This group will receive usual care with robotic assessment.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer upper extremity motor function score (FMA)
时间窗: From baseline to 44 days
FMA scores upper extremity motor impairment based on 22 items and scores range from 0 (completely plegic) to 66 (normal).
次要结局
- modified Rankin Scale (mRS)(From baseline to 180 days)
- Functional Independence Measure (FIM)(From baseline to 180 days)
- Action Research Arm Test (ARAT)(From baseline to 180 days)
- Robotic Assessments(From baseline to 180 days.)
研究者
Dr. Sean Dukelow
Associate Professor of Physical Medicine and Rehabilitation
University of Calgary
