Dose-Response Effects of Whole Body Vibration on Spasticity and Walking in SCI

全身振动对 SCI 痉挛和行走的剂量反应效应

• 批准号: 8628318
• 负责人: EDELLE C. FIELD-FOTE
• 金额: $ 29.43万
• 依托单位: SHEPHERD CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-02 至 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8628318
• 关键词: Address; Adverse effects; Behavior; Cerebral Palsy; Chronic; Clinical; Clinical Trials; Development; Dose; Effectiveness; Frequencies; Functional disorder; Health; Human; Impairment; Intervention; Leg; Motor; Movement; Multiple Sclerosis; Muscle Contraction; Neurologic; Neuronal Plasticity; Outcome; Outcome Measure; Pain; Pain in lower limb; Pattern; Persons; Pharmacologic Substance; Phase; Physical Function; Placebos; Plague; Population; Quality of life; Recording of previous events; Rehabilitation Research; Rehabilitation therapy; Relative (related person); Skeletal Muscle; Sleep; Smooth Muscle; Speed; Spinal; Spinal cord injury; Staging; Stroke; Therapeutic; Time; Traumatic Brain Injury; Walking; Water; Work; Youth; care burden; clinically relevant; cost; experience; improved; improved functioning; innovation; interest; motor function improvement; muscle strength; neural circuit; neuropathology; public health relevance; rehabilitation science; rehabilitation strategy; repetitive task practice; research study; response; vibration; years lived with disability

DESCRIPTION (provided by applicant): People with spinal cord injury (SCI) experience uncontrolled involuntary muscle contractions (spasticity) that disrupt mobility, sleep, and comfort. Spasticity is typically treated pharmacologically, with myriad side effects. A more obvious consequence of SCI is impaired voluntary muscle control, of which limitations of walking function are one of the most devastating consequences. Numerous clinical trials have attempted to address these issues, however, to date no studies have undertaken a systematic approach that involves identify dose-response relationships, in the manner of pharmaceutical trials, prior to the intervention. Afferent input in the form of vibration has long been known to have a powerful effect on neural circuits; whole body vibration (WBV) represents an intense and generalized form of this afferent input. Preliminary studies from our lab suggest that afferent input in the form WBV may reduce spasticity improve walking and persons with SCI. Our findings related to the influence of WBV on spasticity are supported by a long history of studies showing that local vibration activates modulatory mechanisms. Recent studies from our lab have shown that local vibration elicits involuntary step-like behavior, even in persons with motor-complete SCI. Much of the prior work of our lab has centered on the use of afferent input, often combined with repetitive task practice, to promote neuroplasticity and improved motor function in persons with SCI. However, we have never been sure that the dose of afferent input (or the dose of practice) we used was optimal. This is a common problem that plagues rehabilitation research. Questions of dose are needed before progressing to larger trials. There is a clear need for rehabilitation research studies that are developed in progressive stages in the manner of pharmaceutical trials. Accordingly, the proposed study is a 2-Phase development-of-concept trial intended to evaluate dose-response effects, identify the most suitable outcome measures, and select optimal components of the intervention. This study will provide answers related to dose effects of WBV on spasticity, walking function, pain, and muscle strength by focusing on the following Aims: Specific Aim 1. (Phase 1; Years 1 - 2) Quantify early and late within-session effects on spasticity and walking function of 5 different WBV doses (4 doses, plus placebo) delivered 1 week apart. Specific Aim 2. Quantify the cumulative and persistent dosing effects on spasticity of once daily (1xWBV) versus twice daily (2xWBV) WBV at the dose most effective for reducing spasticity. Specific Aim 3 (Phase 2; Years 3 - 5). Quantify the cumulative and persistent dosing effects on walking function of 1xWBV versus 2xWBV at the most effective dose. Specific Aim 4 (Phase 2; Years 3 - 5). Characterize the cumulative and persistent dosing effects on pain and leg strength of 1xWBV versus 2xWBV at the most effective dose.

描述（由申请人提供）：脊髓损伤（SCI）患者经历不受控制的不自主肌肉收缩（痉挛），破坏活动性，睡眠和舒适性。痉挛是典型的治疗手段，有无数的副作用。SCI的一个更明显的后果是受损的随意肌肉控制，其中步行功能的限制是最具破坏性的后果之一。许多临床试验试图解决这些问题，然而，迄今为止，没有研究进行了系统的方法，涉及确定剂量-反应关系，在药物试验的方式，在干预之前。振动形式的传入输入长期以来一直被认为对神经回路有强大的影响;全身振动（WBV）代表了这种传入输入的强烈和普遍形式。我们实验室的初步研究表明，WBV形式的传入输入可以减少痉挛，改善行走和SCI患者。我们的研究结果与WBV对痉挛的影响有关，这一发现得到了长期研究的支持，这些研究表明局部振动激活了调节机制。我们实验室最近的研究表明，即使在运动型完全性SCI患者中，局部振动也会诱发无意识的步状行为。我们实验室之前的大部分工作都集中在使用传入输入，通常与重复性任务练习相结合，以促进SCI患者的神经可塑性和改善运动功能。然而，我们从来没有确定我们所使用的传入输入的剂量（或练习的剂量）是最佳的。这是困扰康复研究的一个常见问题。在进行更大规模的试验之前，需要考虑剂量问题。显然需要以药物试验的方式逐步发展的康复研究。因此，拟定的研究是一项2期概念开发试验，旨在评价剂量-反应效应，确定最合适的结局指标，并选择最佳干预成分。本研究将通过关注以下目的，提供与WBV对痉挛、行走功能、疼痛和肌肉力量的剂量效应相关的答案：具体目的1。（第一阶段;第1 - 2年）量化间隔1周给药的5种不同WBV剂量（4种剂量，加上安慰剂）对痉挛和行走功能的早期和晚期治疗期内影响。具体目标2。量化每日一次（1xWBV）与每日两次（2xWBV）WBV在最有效减轻痉挛的剂量下对痉挛的累积和持续给药效应。具体目标3（第2阶段; 3 - 5年）。量化1xWBV与2xWBV在最有效剂量下对行走功能的累积和持续给药效应。具体目标4（第2阶段; 3 - 5年）。表征1xWBV与2xWBV在最有效剂量下对疼痛和腿部力量的累积和持续给药效应。