Weight Change With Controlled Ankle Movement (CAM) Boot Use

NCT05692401 | Terminated

• 1 other identifier: STUDY 00021093
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Injuries; Foot Injuries and Disorders; Body Weight Changes

Keywords

controlled ankle movement; CAM boot

Outcome Measures

Primary Outcomes (1)

• Weight change

  Height and weight recorded at enrollment and discontinuation of CAM boot

  12 weeks

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Nutrition and Exercise Instruction

ACTIVE COMPARATOR

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

Interventions

Nutrition and Exercise Instruction 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.

Nutrition and Exercise Instruction

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nell Blake, DPM: lead
• Milton S. Hershey Medical Center: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Foot Injuries; Disease; Body Weight Changes

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Nell Blake, DPM

  Penn State Health Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Profesor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: June 7, 2023
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)