Cyclical Muscle Vibration in MS to Improve Walking
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- 10MWT
研究概览
简要总结
The primary goal of this pilot study is to explore the feasibility of cyclic vibration (CV) of the lower extremity muscles to improve walking in individuals with gait deficits from multiple sclerosis (MS).
详细描述
This pilot study is designed to test the efficacy and safety of vibration at correcting the typical gait deficits that involve strength and coordination of multiple joints (hip, knee and ankle) in pre- and early swing phases of the gait cycle.
Aim 1: Develop a real-time control algorithm, timed by sensor detected gait events, to provide vibration emulating electromyographic (EMG) activity of target muscles during normal gait and verify its functionality in an able-body volunteer. Further, recruit 12 subjects (6 for CV and 6 controls) with gait deficits at the hip, knee and ankle from MS. Impose vibration during the gait cycle so that it emulates muscle activity pattern of normal gait. Perform baseline quantitative gait analyses to determine the spatio-temporal parameters, foot-to-floor clearance, kinematics, kinetics and patterns of EMG activity during walking with and without vibration in treatment group and without vibration in control group.
Aim 2: Implement 12 sessions (3/week for a month) of gait training with cyclic vibration emulating normal muscle activity of lower extremities in treatment group and gait training without vibration in control group and repeat baseline gait assessment to test the following hypotheses.
Hypothesis 1. Vibration of hip, knee and ankle muscles improves walking speed and foot-to-floor clearance through increased hip and knee pre-swing flexion and improved hip-knee coordination.
Hypothesis 2. Gait training with cyclic muscle vibration induces carryover effects that maintain improved walking after vibration is discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS diagnosis reviewed and confirmed by neurologist per the revised McDonald criteria [ ]
- •Age 18-70
- •Fixed gait deficiency defined as being present for at least 3 months without improvement
- •Hip, knee and ankle muscle weakness or increased extensor tone with difficulty to initiate a step
- •Ability to ambulate at least 10ft with contact guard.
- •Muscle vibration without untoward sensation.
- •Sufficient upper extremity function to use walking aids (walkers, crutches, canes).
- •Poor hip-knee-ankle coordination during swing
- •Hip, knee and ankle joint range within normal limits.
- •Ability to clearly understand written and oral direction in English to provide consent.
- •BMI < 30
- •Absence of psychological and cognitive problems or chemical dependency
- •No acute orthopedic or medical complications
排除标准
- •Presence of demand pacemakers.
- •Edema of the affected limb/s.
- •Uncontrolled seizures/epilepsy.
- •Severe depression.
- •Botulin toxin treatment within 12 months.
- •Peripheral neuropathy.
- •Respiratory disease.
- •Chronic pain.
- •Rapidly progressive course suggestive of Marburg variant, Hurst encephalomyelitis or PPMS with three or more system involvement.
- •Concurrent treatment with Tysabri.
- •Cardiac arrhythmias with associated hemodynamic instability.
- •Lower extremity injuries that limit range of motion or function
- •Joint problems (hip or leg) that limit range of motion or cause pain with movement
- •Women during pregnancy
- •Patients with a relapse in the 3 months prior to presentation for study evaluation
- •Patients with more than two relapses within the past 12 months
结局指标
主要结局
10MWT
时间窗: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Outcome measures were tested both with and without muscle vibration and repeated measures were collected and averaged.
speed (m/s)
Toe Clearance
时间窗: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Toe clearance between foot and the ground during swing
Kinematics
时间窗: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Peak hip, knee and ankle flexion during swing
Walking Distance
时间窗: baseline and after twelve 1 hour sessions in four weeks of gait training with muscle vibration. Repeated measures were collected and averaged
Volitional walking distance at baseline and after gait training with vibration
次要结局
未报告次要终点