Weight Change With Controlled Ankle Movement (CAM) Boot Use

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

Official Title
-----------------
Weight Change With Controlled Ankle Movement (CAM) Boot Use

Conditions
-----------------
Ankle Injuries, Foot Injuries and Disorders, Body Weight Changes

Intervention / Treatment
-----------------
* Behavioral: Nutrition and Exercise Instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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. | |
| Active Comparator: Nutrition and Exercise Instruction<br>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. | Behavioral: Nutrition and Exercise Instruction<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Height and weight recorded at enrollment and discontinuation of CAM boot | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
controlled ankle movement, CAM boot