Weight Change With Controlled Ankle Movement (CAM) Boot Use
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 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 boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.
详细描述
The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater or equal to 18 years
- •Participants with foot or ankle injury who are prescribed a CAM boot as standard of care
- •Participants willing to have height and weight measured at the time of enrollment and final visit
- •Participant is able to provide voluntary, written consent
- •Fluent in written and spoken English
- •Participant in the opinion of the Principal Investigator, is able to understand the clinical investigation
排除标准
- •Age less than 18 years
- •Pregnant women
- •Participants with vertigo or other balance issues
- •Participants unable to provide informed consent
- •Participants with foot or ankle injury who will not be wearing a CAM boot
- •Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations
研究组 & 干预措施
Standard of Care
CAM boot prescribed as standard of care. No nutritional guidelines or upper body exercises instructions provided. Height and weight recorded at enrollment and final visit.
Nutrition and Exercise Instruction
CAM prescribed as standard of care. Nutritional guidelines provided and upper body exercise instructions provided. Height and weight recorded at enrollment and final visit. Subjects in this group will undergo a follow up interview that will ultimately be used to examine and assess the helpfulness of the intervention in preventing weight for CAM boot wearing patients.
干预措施: Nutrition and Exercise Instruction (Behavioral)
结局指标
主要结局
Weight change
时间窗: 12 weeks
Height and weight recorded at enrollment and discontinuation of CAM boot
次要结局
未报告次要终点
研究者
Nell Blake, DPM
Assistant Profesor
Milton S. Hershey Medical Center