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

NCT02643524 | Terminated

• 1 other identifier: IRB - 2324
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Injury; Ankle Injury

Keywords

Adult; CAM boot; controlled ankle movement

Outcome Measures

Primary Outcomes (1)

• Weight change

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

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

Secondary Outcomes (1)

• Nutritional status (Pre- and post-albumin levels)

  Enrollment through study completion, an average of 12 weeks.

Study Arms (2)

Nutrition and Exercise Counseling

ACTIVE COMPARATOR

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

Control

ACTIVE COMPARATOR

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

Interventions

Nutrition and Exercise Counseling BEHAVIORAL

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.

Nutrition and Exercise Counseling

Control BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nell Blake, DPM: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Foot Injuries; Ankle Injuries

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Nell Blake, DPM

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Orthopaedics

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: December 31, 2015
• Study Start: December 7, 2015
• Primary Completion: April 9, 2018
• Study Completion: May 23, 2019
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)