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

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.

Study Overview

• Status: Terminated
• Conditions: Ankle Injury; Foot Injury
• Intervention / Treatment: Behavioral: Nutrition and Exercise Counseling; Behavioral: Control

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Nutrition 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.
Active Comparator: 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	Behavioral: Control; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Nell Blake, DPM
• Investigators: Principal Investigator: Nell Blake, DPM, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): May 23, 2019

Study Registration Dates

• First Submitted: December 29, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Adult; CAM boot; controlled ankle movement
• Additional Relevant MeSH Terms: Leg Injuries; Body Weight; Wounds and Injuries; Ankle Injuries; Body Weight Changes; Foot Injuries
• Other Study ID Numbers: IRB - 2324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No