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

Primary Purpose

Foot Injury, Ankle Injury

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nutrition and Exercise Counseling

Control

About this trial

This is an interventional treatment trial for Foot Injury focused on measuring Adult, CAM boot, controlled ankle movement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age greater or equal to 18 (male or female)
Participants prescribed a CAM boot as standard of care from the study investigator's practice
Participant willing to have weight measured at the clinic site at time of enrollment and final visit
Participants willing to have blood drawn for Albumin level at beginning and end of study
Participant is able to provide voluntary, written informed consent
Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
Fluent in written and spoken English

Exclusion Criteria:

Participants less than 18 years of age
Pregnant women
Cognitive impairment
Participants with vertigo or other balance issues
Participants unable to provide informed consent
Non-English speaking individuals
Participants who will not be wearing a CAM boot for at least 6 weeks
Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines

Sites / Locations

Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Nutrition and Exercise Counseling

Control

Arm Description

CAM boot prescribed as standard of care Nutritional counseling provided Upper body exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit Patients in this arm compared with patients in control arm

CAM boot prescribed as standard of care No nutritional or exercise counseling provided Blood drawn for Albumin level at enrollment and final visit Height and weight measured at enrollment and final visit

Outcomes

Primary Outcome Measures

Weight change

Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks.

Secondary Outcome Measures

Nutritional status (Pre- and post-albumin levels)

Pre- and post-albumin levels to measure protein and provide nutritional status

Full Information

NCT ID

NCT02643524

First Posted

December 29, 2015

Last Updated

June 26, 2019

Sponsor

Nell Blake, DPM

1. Study Identification

Unique Protocol Identification Number

NCT02643524

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

Recruitment difficulties

Study Start Date

December 7, 2015 (Actual)

Primary Completion Date

April 9, 2018 (Actual)

Study Completion Date

May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nell Blake, DPM

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to determine if patients wearing a CAM walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.

Detailed Description

The study objectives are: (1) Determine if patients wearing a CAM (Controlled Ankle Movement) walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercises (gender appropriate) information at the time the CAM boot is dispensed; and (2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Injury, Ankle Injury

Keywords

Adult, CAM boot, controlled ankle movement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutrition and Exercise Counseling

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Nutrition and Exercise Counseling

Intervention Description

Patients are prescribed CAM boot and provided nutritional and upper body exercise counseling at the time the CAM boot is dispensed. Patients will be given a diary to complete their daily meal intake (optional), seated upper body physical exercise guidelines and asked to perform them three days per week and each exercise three times per session if able. They will be asked to record number of hours CAM boot is worn daily in the Patient Diary, if one is utilized. Albumin lab test will be drawn and their height and weight measured.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

Patients are prescribed CAM boot. No nutritional or exercise guidelines will be provided. Patients will be given a diary to complete their daily meal intake and physician exercise (if any) and number of hours CAM boot is worn daily. Albumin lab test will be drawn and their height and weight measured.

Primary Outcome Measure Information:

Title

Weight change

Description

Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks.

Time Frame

Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks

Secondary Outcome Measure Information:

Title

Nutritional status (Pre- and post-albumin levels)

Description

Pre- and post-albumin levels to measure protein and provide nutritional status

Time Frame

Enrollment through study completion, an average of 12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age greater or equal to 18 (male or female) Participants prescribed a CAM boot as standard of care from the study investigator's practice Participant willing to have weight measured at the clinic site at time of enrollment and final visit Participants willing to have blood drawn for Albumin level at beginning and end of study Participant is able to provide voluntary, written informed consent Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits. Fluent in written and spoken English Exclusion Criteria: Participants less than 18 years of age Pregnant women Cognitive impairment Participants with vertigo or other balance issues Participants unable to provide informed consent Non-English speaking individuals Participants who will not be wearing a CAM boot for at least 6 weeks Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nell Blake, DPM

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

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

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

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