Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
The overall objective of the study is to test whether the use of small electrical currents to stimulate proprioceptors of the upper limb has potential for improving robot-assisted upper-limb rehabilitation in stroke survivors.
详细描述
Study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with unloading of the stroke-affected arm thus facilitating the performance of upper-limb movements. The system will be used to track the movements of the stroke-affected arm. Simultaneously, a custom-designed system (a prototype developed by the investigators) will be used to deliver small electrical currents to the arm. We hypothesize that the currents delivered to the arm will improve the accuracy of the movements performed by study participants.
To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. Because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.
It is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. Data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •unilateral and cortical, subcortical, or cerebellar stroke
- •6 months post-stroke
- •Upper extremity impairments but able to move upper extremity against gravity 25% of the range
- •Ability to understand directions and follow simple instructions
- •Medically stable
- •Upper Extremity Fugl-Meyer between 28 and 55
- •At least four (4) months since last botox treatment
- •Mini-Mental State Examination (MMSE) ≥ 23
排除标准
- •Participation in other forms of therapy/ intervention for upper extremity motor recovery
- •Upper extremity or trunk fractures
- •Severe fixed contractures affecting the upper limbs
- •Severe perceptual deficits or visual field impairments
- •Severe cognitive deficits
- •Pregnant women
- •Presence of an implanted electrically operated medical device
- •Evidence of more than one clinical stroke
- •Serious medical or neurological illness
- •History of head trauma or cerebral infectious disease
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: Changes in Fugl-Meyer Assessment score with vs without stimulation
Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)
次要结局
- Modified Ashworth Scale(Change in Modified Ashworth Scale score with vs without stimulation)
- Box and Block test(Change in Box and Block test score with vs without stimulation)
- Grip strength(Change in grip strength with vs without stimulation)
- Jebsen-Taylor Hand Function Test(Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation)
- Motor Activity Log(Change in Motor Activity Log score with vs without stimulation)
研究者
Yong-Tae Lee
Physiatrist
Spaulding Rehabilitation Hospital