Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Core strength and endurance bridge
研究概览
简要总结
The purpose of this study is to determine the impact of rehabilitative training of the abdominal wall with direct current neuromuscular electrical stimulation (the NEUBIE device) on recovery time from abdominoplasty (tummy tuck).
详细描述
Participants will undergo abdominoplasty surgery and begin rehabilitation training within the first week post-operation. Standardized measurements of recovery progress will be taken starting prior to operation, and at 2, 4, 6, 8 and 12 weeks post-operation. Participants will undergo either the traditional standard of care of rest, with minimal activity for at least 6 weeks (control group) or a 5 week training course with the NEUBIE (experimental group), starting with passive electrical stimulation in the first week post-operation, and moving towards more advanced abdominal movements accompanied with stimulation in the subsequent four weeks.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes will be assessed at Piazza Surgical Center. Assessors will be blinded to which intervention participant has received.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Rectus Diastasis
- •Previous pregnancy
- •Excess localized adiposity in the lower abdomen
- •Excess atrophic skin of the abdomen
- •Physician clearance to participate
- •Scheduled for full abdominoplasty (no mini-abdominoplasty included)
排除标准
- •Currently pregnant
- •Cardiac Pacemaker
- •Active or recent cancer in the abdominal area
- •Active or recent blood clots in the abdominal area
- •History of epilepsy
结局指标
主要结局
Core strength and endurance bridge
时间窗: 12 weeks
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Bio-impedance analysis trunk fat
时间窗: 12 weeks
Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat.
Bio-impedance analysis trunk mass
时间窗: 8 weeks
Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass.
Range of Motion
时间窗: 12 weeks
Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs.
Core strength and endurance plank
时间窗: 12 weeks
Core strength and endurance will be measured by duration of ability to hold a plank.
Lower abdominal strength
时间窗: 12 weeks
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Sit up Test
时间窗: 12 weeks
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Bio-impedance analysis muscle mass
时间窗: 12 weeks
Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass.
次要结局
未报告次要终点