Robotic Pedaling Therapy for Targeted Neural Plasticity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Six Minute Walk Test (6MWT) Distance
研究概览
简要总结
The aim of this Pilot study is to determine whether robotically targeted lower-limb pedaling therapy can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Forty (40) adult stroke patients and 80 healthy controls will be enrolled in this study. Of the 40 patients, half will be randomly assigned to the robotically-targeted training ("robotic") group and will receive training on the targeted training task. The other half of the patients will perform a duration-matched aerobic pedaling exercise ("control" group). All stroke patients will be scanned before and after their training program while performing or imagining simple motor tasks. Behavioral assessments of motor and cognitive capacities will be collected at each timepoint. Healthy control subjects enrolled for device testing (20) will receive up to 5 training sessions in a modified robotic paradigm and 1 fMRI scan, in order to investigate motor learning and brain activity in a novel motor control task. Additional healthy pilot subjects (up to 60) will test training protocols and assessments during preparatory design phases of the project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •Subjects will be stroke patients with persistent moderate unilateral lower extremity deficits, age 50-85 years at time of enrollment.
- •Time since stroke will be greater than 6 months ("chronic" stroke survivors).
- •Persistent moderate unilateral lower-limb impairment (defined as NIH Stroke Scale - Motor Leg section score of 1-2, to be discussed with the patient verbally during phone screening and assessed by the investigator during the initial enrollment visit).
- •Fluent in spoken and written English
排除标准
- •Allergy to electrode gel, surgical tape and metals.
- •Subjects under treatment for infectious diseases will be excluded from the study.
- •Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
- •Contraindications for MRI
- •Age over 85 years at time of enrollment.
- •Healthy Controls:
- •Inclusion criteria:
- •Ages 18-85 years
- •Non-Stroke Group 1 ("Matched Controls"): 50-85 years old at time of enrollment, to match the population of stroke patients to be studied
- •Non-Stroke Group 2 ("Pilot Controls"): 18-50 years old at time of enrollment (Pilot subjects to be initially enrolled early in the design phase of the study, and with enrollment ongoing throughout the study to continue development.)
- •No known neurologic, psychiatric or developmental disability.
- •Fluent in spoken and written English
- •Exclusion criteria:
- •Allergy to electrode gel, surgical tape, and metals.
- •Subjects under treatment for infectious diseases will be excluded from the study.
- •Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
- •Contraindications for MRI
- •Age over 85 years at time of enrollment.
研究组 & 干预措施
Non-Stroke Pilot Group
Robotic therapy. Aerobic therapy. Subjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.
干预措施: Aerobic therapy (Device)
Non-Stroke Pilot Group
Robotic therapy. Aerobic therapy. Subjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.
干预措施: Robotic therapy (Device)
Non-Stroke Comparison Group
Robotic therapy. Healthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.
干预措施: Robotic therapy (Device)
Robotic Training Group
Robotic therapy. Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.
干预措施: Robotic therapy (Device)
Aerobic Training Group
Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
干预措施: Aerobic therapy (Device)
结局指标
主要结局
Change in Six Minute Walk Test (6MWT) Distance
时间窗: Baseline and at 5 weeks
A simple series of laps along a 30 m straight path in a level hallway.
次要结局
- Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)(Baseline and at 5 weeks)
- Change in Self-Selected Walking Speed (SSWS)(Baseline and at 5 weeks)
- Change in Timed Up-and-Go Test (TUG)(Baseline and at 5 weeks)
- Change in Fastest Comfortable Walking Speed (FCWS)(Baseline and at 5 weeks)
- Change in Center of Pressure (COP) Characteristics(Baseline and at 5 weeks)