Ankle Injury, Foot Injury
Conditions
Keywords
Adult, CAM boot, controlled ankle movement
Brief summary
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
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.
Interventions
BEHAVIORALNutrition and Exercise Counseling
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.
BEHAVIORALControl
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.
Sponsors
Nell Blake, DPM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks | Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status (Pre- and post-albumin levels) | Enrollment through study completion, an average of 12 weeks. | Pre- and post-albumin levels to measure protein and provide nutritional status |
Countries
United States
Outcome results
None listed