Weight-Bearing Feedback for Fracture Healing

Overseen By Joseph Robin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: TBI, Polytrauma, Pathologic fractures, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Smart Crutch Tip, Weight-Bearing Feedback for fracture healing?

Research shows that using real-time visual biofeedback during weight-bearing can improve therapy compliance in patients with lower extremity fractures, suggesting that feedback systems like the Smart Crutch Tip could help patients follow weight-bearing instructions more accurately, potentially aiding in fracture healing. ^{1 2 3 4 5}

Is the Weight-Bearing Feedback treatment generally safe for humans?

The studies suggest that the Weight-Bearing Feedback treatment, including devices like Smart Crutch Tip, is generally well accepted by patients and shows promise in helping them follow weight-bearing instructions. However, some technical difficulties were noted, and the devices need to be more reliable for routine clinical use. ^{1 3 6 7 8}

How does the Weight-Bearing Feedback treatment differ from other treatments for fracture healing?

The Weight-Bearing Feedback treatment is unique because it uses sensor technology to provide real-time feedback on how much weight a patient is putting on their healing fracture. This helps ensure patients follow their weight-bearing instructions accurately, which can improve healing outcomes compared to traditional methods that lack objective monitoring. ^{1 3 5 9 10}

Research Team

Kenneth A. Egol, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Weight-Bearing Feedback Delivered to Mobile Phone Experimental Treatment 2 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 Feedback Active Control 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

ComeBack Mobility

Collaborator

Trials

1

Recruited

30+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A new ambulatory monitoring system effectively measures weight-bearing on fractured legs, providing continuous data over time, which is crucial for assessing recovery.

In a small patient group with tibial fractures, the system showed that weight-bearing increased as healing progressed, and more rigid fixation methods allowed patients to bear full weight sooner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable monitoring system for measuring weight-bearing during tibial fracture healing. Aranzulla, PJ., Muckle, DS., Cunningham, JL.[2022]

A novel in-situ strain sensor has been developed to objectively measure fracture healing in lower extremity fractures, demonstrating over 2.25 mm of reproducible displacement with just 100 N of axial load in testing on a human cadaver model.

The sensor's ability to measure changes in pin position correlates with the stiffness of the fracture callus, indicating it could serve as an effective clinical tool for assessing bone healing and determining when patients can safely return to weight bearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable strain sensor to monitor fracture healing with standard radiography. Pelham, H., Benza, D., Millhouse, PW., et al.[2018]

A study showed that traditional methods of partial weight bearing after lower limb surgery often lead to significant overloading, with 40.8% of steps exceeding safe limits in the usual mobilization group.

Using an acoustic feedback device in the insole significantly reduced overloading to only 12.7% of steps, indicating that such systems could improve adherence to weight-bearing guidelines and enhance patient safety during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feedback-controlled weight bearing following osteosynthesis of the lower extremity]. Perren, T., Matter, P.[2006]

Partial weight-bearing instructions are crucial for orthopedic patients during recovery, but patient compliance with these instructions is often unclear and varies widely across different training methods.

Recent advancements in biofeedback devices have shown promise in improving patient adherence to partial weight-bearing guidelines, suggesting a potential shift in how patients are trained post-injury or surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current advances in training orthopaedic patients to comply with partial weight-bearing instructions. Hustedt, JW., Blizzard, DJ., Baumgaertner, MR., et al.[2022]

The usability of the OpenGo-Science biofeedback device was rated positively by both patients and physical therapists, with mean System Usability Scale (SUS) scores of 79 and 81, indicating it is a suitable option for providing feedback during rehabilitation after lower-limb trauma or surgery.

In contrast, the SmartStep device received mixed reviews, with a mean SUS score of 70 from patients and only 53 from physical therapists, suggesting it may not be as effective or acceptable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback in Partial Weight Bearing: Usability of Two Different Devices from a Patient's and Physical Therapist's Perspective. van Lieshout, R., Pisters, MF., Vanwanseele, B., et al.[2022]

A novel load sensor was developed to measure the load on an injured limb over a two-week period, providing valuable data to improve partial weight bearing prescriptions for tibial fractures.

Preliminary testing showed that the load sensor is effective in capturing load profiles, indicating its potential for enhancing clinical trials and ultimately improving recovery outcomes for tibial fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An insole sensor for recording weight bearing behavior during tibial fracture rehabilitation. North, K., Maass, SD., Hitchcock, RW.[2020]

A new feedback and analysis system using sensor insoles and a smartphone app has been developed to help patients with lower extremity injuries monitor their weight-bearing compliance during rehabilitation.

This system provides real-time feedback on pressure and roll-over behavior, which could lead to faster recovery and reduced complications after surgeries like osteotomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback and Analysis System to Improve Partial Weight Bearing and Bone Healing Following Fractures and Osteotomies of the Lower Limb: Technical Note. Stoller, I., Babanin, A., Baumgartner, H., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Controlled weight bearing after osteosynthesis]. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Real-time visual biofeedback during weight bearing improves therapy compliance in patients following lower extremity fractures. [2018]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

New Method for Monitoring Partial Weight Bearing (PWB) of Outpatients with an Independent Insole Sensor System. [2017]

4. England pubmed.ncbi.nlm.nih.gov

A portable monitoring system for measuring weight-bearing during tibial fracture healing. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Implantable strain sensor to monitor fracture healing with standard radiography. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Feedback-controlled weight bearing following osteosynthesis of the lower extremity]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Current advances in training orthopaedic patients to comply with partial weight-bearing instructions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Biofeedback in Partial Weight Bearing: Usability of Two Different Devices from a Patient's and Physical Therapist's Perspective. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

An insole sensor for recording weight bearing behavior during tibial fracture rehabilitation. [2020]

10. Czech Republic pubmed.ncbi.nlm.nih.gov

Feedback and Analysis System to Improve Partial Weight Bearing and Bone Healing Following Fractures and Osteotomies of the Lower Limb: Technical Note. [2021]