Is There an Alternative to Immediate Home Physical Therapy Following Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- 2 Minute Walking Time
研究概览
简要总结
The purpose of this study is to evaluate how different pre-operative therapeutic approaches affect quad strength and patient satisfaction after total knee replacements. There are three treatments groups: standard physical therapy protocol, the use of CyMedica NMES garments, and a telemedical home therapy program.
详细描述
Patients undergoing total knee replacement (TKR) at Brigham and Women's Faulkner Hospital and meet all eligibility criteria will be informed about the study and asked if they would like to participate. The research assistant (RA) will screen upcoming surgeries and call all qualifying patients to inform them of the study. Those who show interest will be offered the opportunity to discuss with both the RA and Principal Investigator (PI). Upon agreement, the patient's consent will be obtained and they will be randomly assigned to one of three treatment groups using a computer-generated randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Owns a device with internet connection
- •Can download the E-vive application for the contractile garment (has sufficiently up-to-date phone or tablet, or has family member with such a device).
- •Has a rudimentary understanding of Internet technology, especially e-mail
- •Has a flexion of 90 o and flexion contracture of 5 o at the point of discharge
- •Approved by a physical therapist to participate safely in the study at the time of discharge
排除标准
- •Rheumatoid arthritis
- •History of epilepsy
- •Implanted and body-worn electronic medical device, including cardiac pacemakers, neural stimulators, insulin pumps, etc.
- •Poor understanding of the use of the brace/electrical stimulation
- •Lesions on the skin over the thigh
- •Uncontrolled diabetes
- •Uncontrolled hypertension
- •Bilateral TKA or UKA planned
- •If female, pregnant
- •Cannot use non-operated leg postoperatively to propel active motion splint, caused by neurological or muscular diseases such as complete or incomplete paralysis or other causes of weakness with an inability to bend or extend knee
- •Loss of sensation in operated or non-operated leg
- •Has below- or above-knee amputations of non-operative leg
- •Below- knee amputation of operated side
- •Chronic pain syndrome with inability to walk
- •Taking chronic narcotics and/or is taking more than 10mg codeine per day, or any Hydrocodone, or more than 200 mg of tramadol, or any other narcotics prescribed for moderate to severe pain
- •Involved in pain clinics for chronic pain, or pain that is not related to the knee
- •Has been diagnosed with knee disorder other than osteoarthritis, post-traumatic osteoarthritis, gout, pseudo gout, or any inability to walk due to disorders unrelated to the knee (e.g., hip disorders, spinal stenosis, paralysis, hemi-paralysis)
研究组 & 干预措施
Group 1, iGetBetter Group
Use only iGetBetter for the 3 months preceding surgery. After surgery, you will be given a new, Post-Op program to use for 2-3 months. For the first 3 weeks, you will only use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks.
干预措施: iGetBetter telemedicine physical therapy (Other)
Group 2, E-vive Group
You will use iGetBetter starting 3 months out from surgery. You will receive CyMedica's electrical-stimulation garment during the preoperative appointment. In addition to iGetBetter, you will wear the conductive garment two times each day for the last 3 weeks before surgery. After surgery, for the first 3 weeks you will only use the conductive garment, and will not use iGetBetter. After those 3 weeks, you will receive outpatient physical therapy in addition to wearing the brace, approximately twice per week for the next 6-8 weeks. You will not need to return the brace after this time is up, and you may keep the brace, if you so choose, at no cost.
干预措施: CyMedica e-vive™ System; CY-1000 (Device)
Group 3, Physical Therapy Group
You will receive only iGetBetter for the 3 months preceding surgery. After surgery, you will receive only home physical therapy, and will not use iGetBetter. After those three weeks, you will receive outpatient physical therapy approximately twice per week for the next 6-8 weeks.
结局指标
主要结局
2 Minute Walking Time
时间窗: Preoperative and postoperative appointments (2 months after surgery)
Change in distance walked in 2 minutes
Balancing
时间窗: Preoperative and postoperative appointments (2 months after surgery)
Change in proprioception (balance) as measured by 30-second single limb stance PT test
Quadriceps Strength
时间窗: Preoperative and postoperative appointments (2 months after surgery)
Change in quadriceps strength in lbs of force, as measured by PT dynamometer
Sit-to-stand Time
时间窗: Preoperative (varies) and postoperative appointments (2 months after surgery)
Change in sit-to-stand capabilities
Walking Speed
时间窗: Preoperative and postoperative appointments (2 months after surgery)
Change in walking speed
次要结局
- Readmission Rate(Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery))
- Visual Analogue Scale (VAS) Pain(first postoperative months (from days post-op through 2-month post-operative appointment))
- Visual Analogue Scale (VAS) Satisfaction(first postoperative months (from days post-op through 2-month post-operative appointment))
- Cost Per Treatment Regimen (iGetBetter vs. CyMedica E-vive vs. Home PT)(Completion of study (anticipate one year from start data 4/4/2019))
- Visual Analogue Scale (VAS) Nausea(first postoperative months (from days post-op through 2-month post-operative appointment))
- Infection Rate(Noted by PI at 2nd postoperative appointment (about 10 weeks after surgery))
研究者
Wolfgang Fitz, M.D.
Assistant Professor of Orthopedic Surgery, Harvard Medical School
Brigham and Women's Hospital