Trials / Terminated
TerminatedNCT02643524
Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Nell Blake, DPM · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2015-12-07
- Primary completion
- 2018-04-09
- Completion
- 2019-05-23
- First posted
- 2015-12-31
- Last updated
- 2019-06-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02643524. Inclusion in this directory is not an endorsement.