Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
The purpose of the study is to determine if patients wearing a CAM walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.
详细描述
The study objectives are: (1) Determine if patients wearing a CAM (Controlled Ankle Movement) walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercises (gender appropriate) information at the time the CAM boot is dispensed; and (2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater or equal to 18 (male or female)
- •Participants prescribed a CAM boot as standard of care from the study investigator's practice
- •Participant willing to have weight measured at the clinic site at time of enrollment and final visit
- •Participants willing to have blood drawn for Albumin level at beginning and end of study
- •Participant is able to provide voluntary, written informed consent
- •Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
- •Fluent in written and spoken English
排除标准
- •Participants less than 18 years of age
- •Pregnant women
- •Cognitive impairment
- •Participants with vertigo or other balance issues
- •Participants unable to provide informed consent
- •Non-English speaking individuals
- •Participants who will not be wearing a CAM boot for at least 6 weeks
- •Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines
研究组 & 干预措施
Nutrition and Exercise Counseling
CAM boot prescribed as standard of care Nutritional counseling provided Upper body exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit Patients in this arm compared with patients in control arm
干预措施: Nutrition and Exercise Counseling (Behavioral)
Control
CAM boot prescribed as standard of care No nutritional or exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit
干预措施: Control (Behavioral)
结局指标
主要结局
Weight change
时间窗: Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks
Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks.
次要结局
- Nutritional status (Pre- and post-albumin levels)(Enrollment through study completion, an average of 12 weeks.)
研究者
Nell Blake, DPM
Assistant Professor, Department of Orthopaedics
Milton S. Hershey Medical Center