Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Foot Injury, Ankle Injury

Intervention / Treatment
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* Behavioral: Nutrition and Exercise Counseling
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition and Exercise Counseling<br>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 | Behavioral: Nutrition and Exercise Counseling<br>* Patients are prescribed CAM boot and provided nutritional and upper body exercise counseling at the time the CAM boot is dispensed. Patients will be given a diary to complete their daily meal intake (optional), seated upper body physical exercise guidelines and asked to perform them three days per week and each exercise three times per session if able. They will be asked to record number of hours CAM boot is worn daily in the Patient Diary, if one is utilized. Albumin lab test will be drawn and their height and weight measured.<br>|
| Active Comparator: Control<br>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 | Behavioral: Control<br>* Patients are prescribed CAM boot. No nutritional or exercise guidelines will be provided. Patients will be given a diary to complete their daily meal intake and physician exercise (if any) and number of hours CAM boot is worn daily. Albumin lab test will be drawn and their height and weight measured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks. | Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status (Pre- and post-albumin levels) | Pre- and post-albumin levels to measure protein and provide nutritional status | Enrollment through study completion, an average of 12 weeks. | 

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