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| Name | Class |
|---|---|
| ComeBack Mobility | UNKNOWN |
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The goal of this study is to determine if weight-bearing crutch technology that delivers active feedback to patients during their treatment will impact patient compliance with physician instructions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-Bearing Feedback Delivered to Mobile Phone | Experimental | The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. Feedback of this data can be delivered to the patient through a mobile phone application. For Arm A of the study, feedback is delivered to the patient's paired mobile phone, providing them information on how much weight they are exerting on their crutch/injured lower extremity. |
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| No Weight-Bearing Feedback | Active Comparator | The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. For Arm B, no feedback about weight-bearing status is delivered to the patient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight-Bearing Feedback | Behavioral | Feedback on how much weight patients are exerting on their crutch/injured lower extremity (measured via Smart Crutch Tip) will be delivered to their mobile phones. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12 | Average weight put on crutch measured using the Smart Crutch Tip. | Week 2, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recovery | Measured as the duration of time from treatment (operative or non-operative) to recovery. | Up to Week 12 |
| Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth A. Egol, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Kenneth.Egol@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. equests should be directed to Kenneth.Egol@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| Smart Crutch Tip | Device | The device is attached to the crutch and measures how much weight-bearing load is exerted onto its axis. The device is capable of transmitting this data into the patient and physicians' user interface. |
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Participants rate pain using a VAS ranging from 0 (no hurt) to 10 (unbearable pain). A decrease in scores indicates pain decreased during the observational period.
| Baseline, Week 12 |
| Percent (%) of Participants with Injury Complications | Up to Week 12 |
| Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury | Nonunion/malunion assessed using radiographic imaging. | Up to Week 12 |