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NCT05692401 Clinical Trial

Weight Change With Controlled Ankle Movement (CAM) Boot Use

Body Weight Changes Clinical Trial

— CAM  

Official title:
Weight Change With Controlled Ankle Movement (CAM) Boot Use

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05692401
Other study ID # STUDY 00021093
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 7, 2023
Est. completion date December 2026

Study information
Verified date December 2023
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date December 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight change Height and weight recorded at enrollment and discontinuation of CAM boot 12 weeks
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