30 Participants Needed

Weight-Bearing Feedback for Fracture Healing

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Overseen ByJoseph Robin, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if crutch technology that sends feedback to a smartphone about weight distribution on an injured leg can improve adherence to doctor's orders. Participants are divided into two groups: one receives feedback on their phone, while the other does not. The trial suits individuals using crutches for specific leg fractures (tibial plateau, pilon, or ankle) and who have a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative technology that could enhance the recovery experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this weight-bearing feedback technology is safe for patients with fractures?

Research has shown that real-time feedback systems for weight support are well-received. One study found that people followed weight-bearing rules more effectively when they received feedback on crutch use. Specifically, 88% of participants adhered to their weight-bearing instructions correctly with the feedback system. This indicates the system is user-friendly and aids patients in following medical advice.

Additionally, a review of similar feedback systems demonstrated their safety for patients recovering from broken bones. These systems assist patients in gradually increasing weight on injured legs without causing harm. Another study confirmed that both physical therapists and patients found these systems easy to use and beneficial.

Overall, current evidence supports weight-bearing feedback technology as a safe and effective tool for aiding patient recovery.12345

Why are researchers excited about this trial?

Researchers are excited about the weight-bearing feedback system because it offers a novel way to aid fracture healing by providing real-time feedback to patients. Unlike traditional methods that rely on routine check-ups to monitor fracture healing, this system uses a tracking device attached to crutches, sending data directly to a mobile phone app. This allows patients to be actively involved in their recovery by adjusting their weight-bearing habits based on immediate feedback. The hope is that this method will empower patients to optimize their healing process, potentially leading to faster recovery times and better outcomes.

What evidence suggests that this weight-bearing feedback technology is effective for fracture healing?

This trial will compare two approaches to using a weight-bearing tracking system attached to crutches. In one arm, participants will receive weight-bearing feedback on their mobile phones, aiding them in following their doctor's advice for healing broken bones. Research has shown that feedback from crutches can help patients adhere to weight-bearing guidelines. One study found that a device attached to crutches accurately measures the weight a patient places on their injured leg. In the other arm, participants will not receive feedback about their weight-bearing status. Additionally, starting weight-bearing early with guidance is generally safe and can improve recovery after fractures. This technology could simplify adherence to recovery plans.13467

Who Is on the Research Team?

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Kenneth A. Egol, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use weight-bearing crutch technology with or without feedback for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Smart Crutch Tip
  • Weight-Bearing Feedback
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Weight-Bearing Feedback Delivered to Mobile PhoneExperimental Treatment2 Interventions
Group II: No Weight-Bearing FeedbackActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

ComeBack Mobility

Collaborator

Trials
1
Recruited
30+

Published Research Related to This Trial

Patient compliance with postoperative partial weight bearing is challenging, and there is currently no objective method to measure how much weight patients place on their affected limb.
The study aims to develop a pressure-sensitive shoe insert device to accurately assess weight bearing, which could enhance patient education and improve outcomes in postoperative fracture care.
[Controlled weight bearing after osteosynthesis].Perren, T., Matter, P.[2013]
Real-time visual biofeedback significantly improved weight bearing in individuals with lower extremity fractures, increasing loading from 50.9% to 63.2% of body weight in those instructed for full weight bearing.
The use of biofeedback also enhanced the accuracy of weight distribution in touch-down weight bearing, leading to a decrease in variance between individual steps, which suggests better therapy compliance overall.
Real-time visual biofeedback during weight bearing improves therapy compliance in patients following lower extremity fractures.Raaben, M., Holtslag, HR., Leenen, LPH., et al.[2018]
A new insole sensor system was tested on 20 young, healthy subjects to monitor compliance with partial weight bearing (PWB) during a walking task, revealing that 23.6% of steps exceeded the prescribed PWB of 15 kg, indicating potential challenges in adherence to weight-bearing protocols.
The study found a high reliability of the sensor system (interclass correlation coefficient of r = 0.945), suggesting it could be an effective tool for monitoring patients' activity and load on injured limbs during recovery, raising concerns about whether post-operative patients can follow PWB instructions effectively.
New Method for Monitoring Partial Weight Bearing (PWB) of Outpatients with an Independent Insole Sensor System.Döbele, S., Deininger, C., Sandmann, GH., et al.[2017]

Citations

Validation Testing of a New Crutch Tip Biofeedback Device...The study examines whether the ComeBack Mobility crutch tip reporting weight-bearing on the lower extremity is a reliable and valid tool in determining force.
The Impact of Real-Time Biofeedback on Partial ...The utilization of healthy participants eliminates confounding factors such as varying fracture types, quality of reduction, and osteosynthesis.
The Safety and Effectiveness of Early, Progressive Weight ...One key finding of this review was that early, progressive weight bearing appears safe for patients following traumatic fracture. This finding ...
Smart Crutch Tips for Guided Weight-Bearing in PatientsThe goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery ...
Patient experiences and desires for recovery after ankle ...This study investigates patients' experiences of commencing weight-bearing after ankle fracture surgery and their recovery priorities to inform a new ...
The Satisfaction Survey among PT's and Patients after ...Overall, the usability of the CBM crutches was found to be acceptable from the perspective of both physical therapists and patients. This study provides insight ...
Towards Instrumented Crutches for Rehabilitation and ...This paper introduces Smart Crutches, an instrumented crutch system capable of measuring the weight that a patient places on his/her lower extremities and ...
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