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Weight-Bearing Feedback Delivered to Mobile Phone for Fracture Healing

N/A

Recruiting

Led By Joseph Robin, md

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 12

Awards & highlights

Study Summary

This trial tests whether feedback technology can help people follow their doctor's orders better. #Rehabilitation #Technology

Who is the study for?

This trial is for individuals who are set to undergo treatment for specific lower leg fractures (tibial plateau, pilon, or ankle) and will be using crutches. Participants must be willing to consent to the study, use a mobile phone with iOS or Android, and receive care at NYU.Check my eligibility

What is being tested?

The study is testing if smart crutch tips that give weight-bearing feedback can help patients follow their doctor's instructions better. It aims to see if this technology affects how well patients comply with non-weightbearing guidelines during fracture healing.See study design

What are the potential side effects?

Since this trial involves using a special crutch tip rather than medication, traditional side effects like nausea or headaches aren't expected. However, there may be discomfort from adjusting to the new technology.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12

Secondary outcome measures

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

Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury

Percent (%) of Participants with Injury Complications

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weight-Bearing Feedback Delivered to Mobile PhoneExperimental Treatment2 Interventions

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 II: No Weight-Bearing FeedbackActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,548 Total Patients Enrolled

ComeBack MobilityUNKNOWN

Joseph Robin, mdPrincipal InvestigatorNYU Langone Health

Media Library

Weight-Bearing Feedback Clinical Trial Eligibility Overview. Trial Name: NCT05825079 — N/A

Fracture Healing Research Study Groups: No Weight-Bearing Feedback, Weight-Bearing Feedback Delivered to Mobile Phone

Fracture Healing Clinical Trial 2023: Weight-Bearing Feedback Highlights & Side Effects. Trial Name: NCT05825079 — N/A

Weight-Bearing Feedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT05825079 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study seeking participants?

"Clinicaltrials.gov states that this medical study is not presently recruiting patients, despite having been initially posted on April 15th 2023 and the last update being made on April 11th 23. Fortunately, 361 other clinical trials are currently seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Does Weightbearing Crutch Technology Impact Patient Compliance?

2023. "Does Weightbearing Crutch Technology Impact Patient Compliance?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05825079.