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Weight Change With Controlled Ankle Movement (CAM) Boot Use (CAM)

Primary Purpose

Ankle Injuries, Foot Injuries and Disorders, Body Weight Changes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutrition and Exercise Instruction
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring controlled ankle movement, CAM boot

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

Nutrition and Exercise Instruction

Arm 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.

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.

Outcomes

Primary Outcome Measures

Weight change
Height and weight recorded at enrollment and discontinuation of CAM boot

Secondary Outcome Measures

Full Information

First Posted
January 11, 2023
Last Updated
June 7, 2023
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05692401
Brief Title
Weight Change With Controlled Ankle Movement (CAM) Boot Use
Acronym
CAM
Official Title
Weight Change With Controlled Ankle Movement (CAM) Boot Use
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries, Foot Injuries and Disorders, Body Weight Changes
Keywords
controlled ankle movement, CAM boot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm 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.
Arm Title
Nutrition and Exercise Instruction
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition and Exercise Instruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change
Description
Height and weight recorded at enrollment and discontinuation of CAM boot
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Weight Change With Controlled Ankle Movement (CAM) Boot Use

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