Weight Change With Controlled Ankle Movement (CAM) Boot Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Weight change
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Weight change
Time Frame: 12 weeks
Height and weight recorded at enrollment and discontinuation of CAM boot
Secondary Outcomes
No secondary outcomes reported
Investigators
Nell Blake, DPM
Assistant Profesor
Milton S. Hershey Medical Center