Weight Change With Controlled Ankle Movement (CAM) Boot Use

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05692401

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Injuries Foot Injuries and Disorders Body Weight Changes	Behavioral: Nutrition and Exercise Instruction	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Weight Change With Controlled Ankle Movement (CAM) Boot Use

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Weight change [12 weeks]
Height and weight recorded at enrollment and discontinuation of CAM boot

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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