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



Status:Enrolling by invitation
Conditions:Hospital, Orthopedic, Podiatry
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:7/22/2018
Start Date:December 7, 2015
End Date:December 31, 2020

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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.

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.

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
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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mi
from
Hershey, PA
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