Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Cionic, Inc.
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline
研究概览
简要总结
The purpose of this research is to investigate if a 12-week program of stimulation assisted activities can combat disuse atrophy for individuals diagnosed with knee osteoarthritis (KOA). This study will use a home-based medical device to administer electrical stimulation and measure its effect on outcomes that include quadriceps strength, perceived functional capacity, pain, and walking performance. It was hypothesized that stimulation assisted activities will show larger muscle mass and strength improvements; improved gait kinematics, pain and perceived function; and a high compliance to the assigned program compared to no stimulation.
详细描述
The study aims to evaluate the Cionic Neural Sleeve for subjects diagnosed with KOA. All participants will be assigned a Cionic Neural Sleeve to wear on the most impacted leg and be prescribed a home-based exercise and walking program. Participants will be randomly assigned into three groups: (a) control; (b) neuromuscular electrical stimulation (NMES); (c) NMES and functional electrical stimulation (FES). The control group will not receive stimulation for the exercise and walking program, whereas participants in the NMES group will receive stimulation during exercises, and participants in the NMES and FES group will receive stimulation during exercises and walking. The primary outcome measures include quadriceps strength and perceived pain. Exploratory outcome measures include adherence to the program, thigh muscle volume, functional ability of the lower limb, walking performance, perceived functional capacity, and perceived quality of life.
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
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with knee osteoarthritis between the ages of 22 and 75
- •Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week
- •Able to tolerate the device for up to 1 hour per lab session
- •No recent change in medication or exacerbation of symptoms over the last 60 days
- •Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available
- •No hyaluronic acid or cortisone injection into knees in previous 12 months
排除标准
- •Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
- •Absent sensation in the impacted or more impacted leg
- •Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation
- •Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
- •Use of FES devices in the past year
- •Demand-type cardiac pacemaker or defibrillator
- •Malignant tumor in the impacted or more impacted leg
- •Existing thrombosis in the impacted or more impacted leg
- •Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
- •History of knee replacement surgery
- •History of other types of arthritis
- •History of neurological disease
- •History of seizures or diagnosed with epilepsy/seizures
- •Current pregnancy
结局指标
主要结局
Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline
时间窗: Baseline, 6 weeks, 12 weeks
Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons. Subjects performed 3 repetitions of maximal effort, separated by two minutes of rest between each. The average of the 3 repetitions was recorded as the subjects' 1 repetition maximum. A positive change indicates increased quadriceps strength.
Change in Perceived Pain Scores From Baseline
时间窗: Baseline, 6 weeks, 12 weeks
Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire to measure perceived pain, measured by score. Scores on the WOMAC pain subscale range from 0 to 20, with high scores indicative of worse pain. A positive change indicates improvement.
次要结局
未报告次要终点
研究者
Rebecca Webster
Director of Clinical Operations and Research
Cionic, Inc.