Peripheral Nerve Stimulation and Motor Training to Enhance Hand Function After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Wolf Motor Function Test
研究概览
简要总结
Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. The investigators will non-invasively stimulate peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that peripheral nerve stimulation will enhance effects of motor training in patients in the chronic stage after stroke.
详细描述
The objective of this protocol is to determine whether a neuromodulation intervention associated with functional electrical stimulation, when combined with task-specific training over several sessions, decreases upper limb motor disability, motor impairment, overall disability and improves quality of life compared to the sham intervention and functional electrical stimulation.
The interventions will consist of three sessions per week, over six weeks, of outpatient functional electrical stimulation of the paretic wrist and task-specific training. In each session, either active peripheral nerve stimulation (PNS) or sham PNS will be applied. Before the first session, patients will be familiarized with the procedures.
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
- Triple (Participant, Care Provider, 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
- •Age, 18 years or older;
- •Ischemic or hemorrhagic stroke at least six months before, confirmed by computed tomography or magnetic resonance imaging;
- •Moderate to severe motor impairment of an upper limb, defined as a score between 7 and 50 on the Fugl-Meyer Assessment of Sensorimotor Recovery after stroke, a scale with scores for upper limb ranging from 0 (no function) to 66 (normal function);
- •Ability to provide written Informed Consent (patient or legal representative);
- •Ability to comply with the schedule of interventions and evaluations in the protocol.
排除标准
- •Lack of ability to voluntarily activate any active range of wrist extension;
- •Anesthesia of the paretic hand;
- •Severe spasticity at the paretic elbow, wrist, or fingers, defined as a score of >3 on the Modified Ashworth Spasticity Scale;
- •Active joint deformity;
- •Uncontrolled medical problems such as end-stage cancer or renal disease;
- •Pregnancy;
- •Seizures, if current use of drugs that may decrease seizure threshold such as tryciclic antidepressants;
- •Pacemakers;
- •Other neurological disorders such as Parkinson's disease;
- •Psychiatric illness including severe depression;
- •Aphasia or serious cognitive deficits that preclude comprehension of the experimental protocol or ability to provide consent;
- •Treatment of upper limb spasticity with botulinum toxin within the past three months.
- •Lesions that affect the cerebellum or cerebelar/vestibular pathways in the brainstem
结局指标
主要结局
Wolf Motor Function Test
时间窗: 6 weeks
The primary outcome will be evaluated before the intervention and 6 weeks after the beginning of the intervention.
次要结局
- Modified Ashworth Scale(18 weeks)
- Minimal Clinically Important Difference - Wolf Motor Function Test - time(18 weeks)
- Motor Activity Log(18 weeks)
- Active range of motion of wrist extension in the paretic side(18 weeks)
- Grip force in the paretic side(18 weeks)
- Barthel Index(18 weeks)
- Stroke Impact Scale(18 weeks)
- Minimal Clinically Important Difference - Wolf Motor Function Test - Functional Ability Scale(18 weeks)
- Active range of motion of wrist flexion in the paretic side(18 weeks)
- Grasp force in the paretic side(18 weeks)
- Fugl-Meyer Assessment of Sensorimotor Recovery(18 weeks)
- Beck Depression Inventory-short Form(18 weeks)
- Wolf Motor Function Test(18 weeks)
研究者
Adriana Bastos Conforto
Professor
University of Sao Paulo General Hospital