Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
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|ClinicalTrials.gov Identifier: NCT02643524|
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2015
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Foot Injury Ankle Injury||Behavioral: Nutrition and Exercise Counseling Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use|
|Actual Study Start Date :||December 7, 2015|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
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
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.
- 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.
- 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
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
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Nell Blake, DPM||Milton S. Hershey Medical Center|