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

Not Applicable

Terminated

• Conditions: Foot Injury; Ankle Injury
• Interventions: Behavioral: Nutrition and Exercise Counseling; Behavioral: Control

• Registration Number: NCT02643524
• Lead Sponsor: Nell Blake, DPM

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.

Study Timeline

• Study Start: 2015-12-07
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Primary Completion: 2018-04-09
• Study Completion: 2019-05-23
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition and Exercise Counseling	Nutrition and Exercise Counseling	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
Control	Control	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States