Weight Change With Controlled Ankle Movement (CAM) Boot Use

Nell Blake, DPM

Status: Terminated

Conditions: Body Weight Changes; Foot Injuries and Disorders; Ankle Injuries

Treatments: Behavioral: Nutrition and Exercise Instruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05692401

STUDY 00021093

Details and patient eligibility

About

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.

Full 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

Enrollment: 5 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Nutrition and Exercise Instruction