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

The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.

Study Overview

• Status: Terminated
• Conditions: Body Weight Changes; Ankle Injuries; Foot Injuries and Disorders
• Intervention / Treatment: Behavioral: Nutrition and Exercise Instruction

Detailed Description

The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used

• Study Type: Interventional
• Enrollment (Actual): 5
• 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 to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age greater or equal to 18 years
• Participants with foot or ankle injury who are prescribed a CAM boot as standard of care
• Participants willing to have height and weight measured at the time of enrollment and final visit
• Participant is able to provide voluntary, written consent
• Fluent in written and spoken English
• Participant in the opinion of the Principal Investigator, is able to understand the clinical investigation

Exclusion Criteria:

• Age less than 18 years
• Pregnant women
• Participants with vertigo or other balance issues
• Participants unable to provide informed consent
• Participants with foot or ankle injury who will not be wearing a CAM boot
• Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations

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
No Intervention: Standard of Care; CAM boot prescribed as standard of care. No nutritional guidelines or upper body exercises instructions provided. Height and weight recorded at enrollment and final visit.
Active Comparator: Nutrition and Exercise Instruction; CAM prescribed as standard of care. Nutritional guidelines provided and upper body exercise instructions provided. Height and weight recorded at enrollment and final visit. Subjects in this group will undergo a follow up interview that will ultimately be used to examine and assess the helpfulness of the intervention in preventing weight for CAM boot wearing patients.	Behavioral: Nutrition and Exercise Instruction; Eating and exercise patterns. Educational handouts and instructions will be provided, which are intended as a guide for subjects in intervention group. Subjects will also be given a Patient Diary to complete their daily meal intake and physical exercises. Use of and return of the diary is optional but encouraged. It has been found that use of a patient diary to record food intake keeps one from eating more than they planned and can be a useful tool in weight control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Height and weight recorded at enrollment and discontinuation of CAM boot	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CAM boot; controlled ankle movement
• Additional Relevant MeSH Terms: Leg Injuries; Ankle Injuries; Body Weight; Wounds and Injuries; Body Weight Changes; Foot Injuries
• Other Study ID Numbers: STUDY 00021093

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
• product manufactured in and exported from the U.S.: No