Does Weightbearing Crutch Technology Impact Patient Compliance?

NCT ID: NCT05825079

Last Updated: 2026-01-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-09

Study Completion Date

2025-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Fracture Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Weight-Bearing Feedback Delivered to Mobile Phone

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.

Group Type EXPERIMENTAL

Weight-Bearing Feedback

Intervention Type 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.

Smart Crutch Tip

Intervention Type 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.

No 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. For Arm B, no feedback about weight-bearing status is delivered to the patient.

Group Type ACTIVE_COMPARATOR

Smart Crutch Tip

Intervention Type 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.

Interventions

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Weight-Bearing Feedback

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.

Intervention Type BEHAVIORAL

Smart Crutch Tip

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ComeBack Mobility

UNKNOWN

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth A. Egol, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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22-01427

Identifier Type: -

Identifier Source: org_study_id

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