Pedal Pump Clinical Trial on Edema V2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group
研究概览
简要总结
Previous research on the osteopathic manual technique entitled "Pedal Pump" has shown health benefits, specifically increasing lymphatic flow, decreasing lower extremity edema, and decreasing serum lactic acid after maximal exercise. However, due to the limitation of human practitioners, research has been limited.
The Pedal Pump is now a device which facilitates consistency in treatment and allows for increased sample size in research. This clinical trial studies the effects of 10 minutes of Pedal Pump treatment for hospitalized patients with lower extremity edema, almost the same as Pedal Pump Clinical Trial on Edema V1 that is underway; however, this study focuses primarily on the objective data gathered by trained Occupational Therapists who regularly measure lower extremities.
Key Question for this second study: Is the Pedal Pump a feasible treatment for hospitalized patients? Secondary question: Does the Pedal Pump decrease lower extremity edema?
This is a novel idea in its early stage of development, so Investigators anticipate product advancements, further testing with larger population sizes, and future publications.
详细描述
The Pedal Pump is a device which engages the feet of patients while they are in bed. The device is placed between the foot board and the patient's feet. It provides gentle, on-and-off pressure to the feet, which, in turn, mobilizes the whole body in a rhythmic, calming manner.
The proposed hypotheses of the Pedal Pump are primarily based on the health benefits provided by normal walking. They include, but are not limited to…
Physiological Benefits:
- Increase lymphatic flow within the body
- Increase blood flow back to the heart and into the tissues
- Increase intestinal peristalsis
- Increase kidney filtration
- Increase myofascial and musculoskeletal movement
Proposed Patient-Centered Benefits:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral lower extremity edema of at least mild severity judged by the treating clinician to be due to CHF, chronic venous insufficiency, kidney disease, lymphedema, or other etiologies of fluid overload conditions.
- •Medically stable
- •Able to remain in Fowler position for 10 minutes
- •Patients in the ER, observation, or admitted to the hospital for any period of time; outpatients (specifically CHF clinic patients)
- •Patients must give informed consent to participate. The patient must be able to read the consent form (in English or Spanish) or give consent after the form is translated for the patient.
排除标准
- •Lipedema (fat distribution) as the only cause for edema
- •Pressure ulcers
- •Active DVT (i.e. Patients who have signs of acute unilateral swelling must have a documented negative lower extremity venous duplex ultrasound within the current admission before they will be included in the trial.)
- •Symptomatic peripheral vascular disease
- •Wounds or infections in the feet, legs, buttocks, or back deemed unfit for treatment per the trained Operator.
- •Leg or back surgery in previous 30 days
- •Known pregnancy
- •Severe osteoporosis/fracture risk
研究组 & 干预措施
Treatment Group
The Treatment group will experience the Pedal Pump intervention by...
- Being assisted to sit up in their beds at a 45-60 degree Fowler's position. Their thighs, calves, and ankles being marked with a surgical marker at the locations and measured.
- The heel protector pillows being attached to their feet and the Pedal Pump being placed at the foot of the bed.
- Provided the treatment is tolerated by the patient, the Pedal Pump treatment being applied to both feet for 10 minutes continuously mobilizing their whole body in sufficient manner to see the nose move.
- The Operator turning off the device and removing it from the bed.
干预措施: Pedal Pump (Device)
Sham (Control) Group
The Sham Group will have the same experience as Treatment Group with the exact same device generating identical operational sounds and visible movement, but the patient's body will not be close enough to the device to produce sufficient displacement to transmit mechanical forces beyond the feet. The Pedal Pump will only contact the heel protector pillows enough to make the toes move but will not contact them enough to mobilize the legs or the entire body.
干预措施: Pedal Pump Sham (Device)
结局指标
主要结局
Treatment Tolerability in at least 19 of the 20 patients in the Pedal Pump treatment group
时间窗: 10 minutes
≥95% of the subjects receiving the Pedal Pump treatment finished the 10 minutes of treatment without stopping it because of adverse effects (\<5% "aborted" treatments).
次要结局
- Change in Lower Extremity Edema in the Pedal Pump treatment group(10 minutes)