Weight Change With Controlled Ankle Movement (CAM) Boot Use

NCT ID: NCT05692401

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2025-07-10

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

Conditions

Ankle Injuries; Foot Injuries and Disorders; Body Weight Changes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Nutrition and Exercise Instruction

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: collaborator

Nell Blake, DPM

OTHER

Sponsor Role: lead

Responsible Party

Nell Blake, DPM

Assistant Profesor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nell Blake, DPM

Role: PRINCIPAL_INVESTIGATOR

Penn State Health Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY 00021093

Identifier Type: -

Identifier Source: org_study_id