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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02643524
First Posted: December 31, 2015
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nell Blake, DPM, Penn State Milton S. Hershey Medical Center
  Purpose
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.

Condition Intervention
Foot Injury Ankle Injury Behavioral: Nutrition and Exercise Counseling Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use

Resource links provided by NLM:


Further study details as provided by Nell Blake, DPM, Penn State Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Weight change [ Time Frame: Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks ]
    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) [ Time Frame: Enrollment through study completion, an average of 12 weeks. ]
    Pre- and post-albumin levels to measure protein and provide nutritional status


Estimated Enrollment: 50
Actual Study Start Date: December 7, 2015
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nutrition and Exercise Counseling
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
Behavioral: Nutrition and Exercise Counseling
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.
Active Comparator: Control
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
Behavioral: Control
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643524


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Nell Blake, DPM
Investigators
Principal Investigator: Nell Blake, DPM Milton S. Hershey Medical Center
  More Information

Responsible Party: Nell Blake, DPM, Assistant Professor, Department of Orthopaedics, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02643524     History of Changes
Other Study ID Numbers: IRB - 2324
First Submitted: December 29, 2015
First Posted: December 31, 2015
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nell Blake, DPM, Penn State Milton S. Hershey Medical Center:
Adult
CAM boot
controlled ankle movement

Additional relevant MeSH terms:
Wounds and Injuries
Body Weight Changes
Ankle Injuries
Foot Injuries
Body Weight
Signs and Symptoms
Leg Injuries