NCT05692401

Weight Change With Controlled Ankle Movement (CAM) Boot Use

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Nell Blake, DPM · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-07
• Primary completion: 2025-07-10
• Completion: 2025-07-10
• First posted: 2023-01-20
• Last updated: 2025-07-18

Locations

1 site across 1 country: United States