Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
NCT ID: NCT02643524
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
20 participants
INTERVENTIONAL
2015-12-07
2019-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Nell Blake, DPM
OTHER
Responsible Party
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Nell Blake, DPM
Assistant Professor, Department of Orthopaedics
Principal Investigators
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Nell Blake, DPM
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB - 2324
Identifier Type: -
Identifier Source: org_study_id
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