Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)
研究概览
简要总结
The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee range of motion are often worse than preoperative levels for as long as 6 months after surgery and in some cases may persist for many years after that. Such quadriceps strength impairments after TKA have been largely attributed to voluntary activation deficits and can lead to a decrease in functional performance such as decreased gait speed, decreased balance which can lead to falls, and decreased stair climbing & chair rise abilities.
Since therapy alone does not adequately restore or improve upon the preoperative functional capabilities in a consistent and timely manner, it has been suggested that NMES used adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag, increase walking speed, and improve QFM strength, knee range of motion, and function. However, NMES initiated one month after TKA did not lead to improved QFM strength or function beyond the standard benefits gained from exercise alone, thus suggesting that the timing of NMES application after TKA is important.
It has previously been shown that preoperative QFM strength is predictive of postoperative function [6] but the benefit of prehabilitation remains in question. To date, there has only been one pilot study assessing the benefits of NMES when initiated preoperatively. This study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to assess the benefits of NMES both preoperatively and postoperatively in order to determine how it will be most beneficial to TKA patients.
详细描述
The study duration will be until 12 weeks ± 1 week postoperatively. Data will be collected (1) 4 weeks preoperatively, (2) prior to hospital admission for TKA, and (3) at 3, 6, and 12 weeks postoperatively. The research coordinator at the site will identify, recruit, and prospectively follow the 66 patients at his/her site.
All data will be entered and maintained in REDCap, an electronic data capture tools hosted at Cleveland Clinic. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. Only members of the study team (i.e. the personnel listed on the institutional review board (IRB) application) will have access to protected health information of patients included in this study.
Pretreatment Assessments
Before treatment, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the (case report form) CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Informed consent
- Age, gender, height/weight/(body mass index) BMI
- Concomitant diseases
- Physical examination
- Baseline range of motion of affected knee
- Baseline timed up and go test (TUG test, detailed in Appendix A and as described by Podsiadlo et al.)
- Baseline Stair Climb test
- Baseline QFM strength
- Baseline Modified Knee Injury and Osteoarthritis Outcome Score (KOOS) and Veterans Rand 12(VR-12) assessments
- Baseline VAS (visual analog scale)pain score
- Current medications
- Any use of ambulation assist device
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing unilateral primary total knee arthroplasty
- •Patients who are between the ages of 18 - 85 years
- •Patient has signed informed consent
- •Patient has access to a smartphone or tablet (Android or iOS)
排除标准
- •Inflammatory arthritis
- •Patients who are expected to be in extended care facilities after surgery
- •Patients who have used an at-home NMES device in the past
- •Preoperative daily use of narcotics (i.e., high tolerance)
- •Already enrolled in another research study, including the present study for contralateral knee
- •Other lower-extremity orthopaedic conditions which could interfere with limb function, especially those with significant pain requiring daily analgesic intake
- •Patients with concurrent abdominal, inguinal or femoral hernias
- •Cutaneous lesions in areas of electrode pad placement
- •Patients with a history of epilepsy
- •Patients with a cardiac pacemaker/defibrillator
- •Allergy to adhesives
- •Inability to meet follow-up visits required for the study
- •Patients who are a risk for poor compliance or have a poor understanding of the use of the NMES device
- •Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being
结局指标
主要结局
Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)
时间窗: 6 weeks
measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative
次要结局
- Number of Patients Readmitted to Hospital(12 weeks)
- Knee Active Range of Motion (Extension, Flexion) in Degrees(12 weeks)
- KOOS Pain(12 weeks)
- KOOS - PS(12 weeks)
- Hospital Length of Stay (Days)(12 weeks)
- Visual Analogue Scale (VAS) Pain Level (0-10 Scale)(12 weeks)
- Number of Patients Discharged to Extended Care Facility(12 weeks)
- Number of Outpatient Therapy Visits (Patient Questionnaire)(12 weeks)
研究者
Carlos Higuera-Rueda
Staff Surgeon
The Cleveland Clinic