Does Weightbearing Crutch Technology Impact Patient Compliance?

Not Applicable

Recruiting

• Conditions: Fracture Healing
• Interventions: Behavioral: Weight-Bearing Feedback; Device: Smart Crutch Tip

• Registration Number: NCT05825079
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Study Start: 2023-06-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Willing and able to participate in study and complete consent
• Will undergo treatment of an isolated tibial plateau, pilon, or ankle fracture and placed in a non-weightbearing status with the use of crutches at NYU.
• Have access and use of a mobile phone (exclusively iOS and/or Android devices)

Exclusion Criteria

• Patients with concomitant TBI
• Polytrauma patients
• Pathologic fractures
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight-Bearing Feedback Delivered to Mobile Phone	Weight-Bearing Feedback	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.
Weight-Bearing Feedback Delivered to Mobile Phone	Smart Crutch Tip	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.
No Weight-Bearing Feedback	Smart Crutch Tip	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.

Primary Outcome Measures

Name	Time	Method
Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12	Week 2, Week 12	Average weight put on crutch measured using the Smart Crutch Tip.

Secondary Outcome Measures

Name	Time	Method
Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12	Baseline, Week 12	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.
Time to Recovery	Up to Week 12	Measured as the duration of time from treatment (operative or non-operative) to recovery.
Percent (%) of Participants with Injury Complications	Up to Week 12
Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury	Up to Week 12	Nonunion/malunion assessed using radiographic imaging.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States