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

Foot Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02643524
• Other study ID #: IRB - 2324
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2015
• Est. completion date: May 23, 2019

Study information

• Verified date: June 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 23, 2019
• Est. primary completion date: April 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injury
• Body Weight Changes
• Foot Injuries
• Foot Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nell Blake, DPM

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nutritional status (Pre- and post-albumin levels)	Pre- and post-albumin levels to measure protein and provide nutritional status	Enrollment through study completion, an average of 12 weeks.