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

Nell Blake, DPM

Status: Terminated

Conditions: Ankle Injury; Foot Injury

Treatments: Behavioral: Nutrition and Exercise Counseling; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02643524

IRB - 2324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Nutrition and Exercise Counseling

Active Comparator group

Description:

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

Treatment:

Behavioral: Nutrition and Exercise Counseling

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Control