Neural Operant Conditioning to Improve Walking After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Surface electromyographic recording of leg muscles
研究概览
简要总结
The goal of this clinical trial is to learn if operant conditioning can reduce spasticity in order to improve walking in stroke patient. The main questions it aims to answer are:
- Can participants self-regulate reflex excitability
- Can participants self-regulate reflex, reduce spasticity and improve walking Participants will undergo surface stimulation to evoke spinal reflexes and will be asked to control these reflexes therefore reducing spasticity.
Researchers will compare result to able bodied participants to see if [insert effects]
详细描述
The study purpose is to investigate the possibility and later effect of spinal reflex self-regulation in post-stroke stiff-knee gait. The intervention will consist of direct current surface stimulation of the peripheral nerves using electrical stimulation. Stimulation will evoke a motor response that will be collected through surface EMG electrodes and processed to depict a measure of the response as feedback to the participant to complete the loop of operant conditioning. The participant will attempt to modulate their responses over multiple sessions to cause this depiction to either increase or decrease its value depending on an established target.
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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
- 是
入选标准
- •Sign and date consent form
- •At least 3 months since stroke event
- •Over 18 years of age at time of eligibility
- •Ability to stand upright and walk for at least 5 minutes
- •Premorbidly independent
- •Mild to moderate gait impairment
- •Reduced knee flexion during walking relative to the unimpaired side
- •Unilateral hemiparesis of the lower limbs
- •Ability to evoke muscle responses through peripheral nerve stimulation, spinal cord stimulation, and transcranial magnetic stimulation
- •Medically stable
- •Skin intact on hemiparetic leg, abdomen, and scalp
- •Ability to evoke muscle responses and/or reflex responses through peripheral nerve stimulation, spinal cord stimulation, and/or transcranial magnetic stimulation
排除标准
- •Co-existing neurological condition other than prior stroke involving the hemiparetic lower limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
- •History of lower limb musculoskeletal injury
- •Functionally relevant osteoarthritis and weight bearing restriction
- •Functionally relevant polyneuropathy resulting in lack of sensation in the lower leg
- •Functionally relevant cognitive impairment
- •Functionally relevant vision impairment
- •Botox injection to the ipsilateral leg in the last 12 weeks or taking oral anti-spasticity medications
- •Taking part in physical therapy for any walking-related impairment
- •Cardiac pacemaker or other implanted electronic systems
- •Uncontrolled seizure disorder
- •Use of seizure lowering threshold medications and the discretion of the study physician
- •Deficits in communication that interfere with reasonable study participation
- •Severely impaired cognition and communication
- •Severe lower limb pain
结局指标
主要结局
Surface electromyographic recording of leg muscles
时间窗: baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment
Recording electrical activity of leg muscles during walking in response to peripheral nerve stimulation
次要结局
- 10 meter walk test(baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment)
- quadriceps pendulum test(baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment)
- Five Times Sit to Stand Test(baseline, week 6 -mid-treatment, week 12 - end of treatment, 4-week post treatment, 12 weeks post treatment, 24 weeks post treatment)
- Transcranial Magnetic Stimulation (TMS)(Baseline, Week 12 - end of treatment)
研究者
James Sulzer
James Sulzer, PhD
MetroHealth Medical Center