Weight Change with Controlled Ankle Movement (CAM) Boot Use

Not Applicable

• Conditions: Foot Injuries and Disorders; Body Weight Changes; Ankle Injuries
• Interventions: Behavioral: Nutrition and Exercise Instruction

• Registration Number: NCT05692401
• Lead Sponsor: Nell Blake, DPM

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-06-07
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition and Exercise Instruction	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.

Primary Outcome Measures

Name	Time	Method
Weight change	12 weeks	Height and weight recorded at enrollment and discontinuation of CAM boot

Trial Locations

Locations (1)

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