Ankle Injuries, Body Weight Changes, Foot Injuries and Disorders
Conditions
Keywords
controlled ankle movement, CAM boot
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
Interventions
BEHAVIORALNutrition and Exercise Instruction
Eating and exercise patterns. Educational handouts and instructions will be provided, which are intended as a guide for subjects in intervention group. Subjects will also be given a Patient Diary to complete their daily meal intake and physical exercises. Use of and return of the diary is optional but encouraged. It has been found that use of a patient diary to record food intake keeps one from eating more than they planned and can be a useful tool in weight control.
Sponsors
Milton S. Hershey Medical Center
Nell Blake, DPM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | 12 weeks | Height and weight recorded at enrollment and discontinuation of CAM boot |
Countries
United States
Outcome results
None listed