NCT05825079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

April 11, 2023

Last Update Submit

January 2, 2026

Conditions

Fracture Healing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Time to Recovery

    Up to Week 12

  • Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12

    Baseline, Week 12

  • 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

Study Arms (2)

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.

Behavioral: Weight-Bearing FeedbackDevice: Smart Crutch Tip

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.

Device: Smart Crutch Tip

Interventions

Weight-Bearing FeedbackBEHAVIORAL

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.

Weight-Bearing Feedback Delivered to Mobile Phone
Smart Crutch TipDEVICE

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 FeedbackWeight-Bearing Feedback Delivered to Mobile Phone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

  • Kenneth A. Egol, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

June 9, 2023

Primary Completion

July 28, 2025

Study Completion

July 28, 2025

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
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.

Locations

US(1)