RecruitingNot ApplicableNCT07092579

Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures

Study of Individual Weight-bearing and Iterative Walking Using "ComeBack Mobility" Smart Crutch Tips for Mechanical Stimulation of Tibial Shaft Fracture Healing.


Sponsor

Comeback Mobility Inc

Enrollment

30 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for tibial shaft fractures. The study will also assess how safe and practical this approach is in daily outpatient use. Can a personalized weight-bearing program based on CT and finite element analysis help the fracture heal faster? Can it help patients return to full weight-bearing sooner? Can it reduce the fear of movement during recovery? Does iterative walking in the early postoperative period support faster or better bone healing? Researchers will compare standard rehabilitation to different types of personalized weight-bearing programs to see which leads to faster healing, earlier mobility, and better outcomes. Participants will: Use Smart Crutch Tips™ during walking for up to 24 weeks; Follow a personalized weight-bearing prescription based on CT scans and biomechanical modeling; Follow a specific walking plan with real-time audio and visual feedback; Attend six follow-up visits over 36 weeks for clinical exams, x-rays, and CT scans; Complete online questionnaires about pain, activity, and fear of movement.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Finite Element Analysis (FEA), a behavioral approach called Iterative walking, and others for people with tibial fractures and fracture healing. The study is currently recruiting participants at 18 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmart Crutch Tips™

Smart Crutch Tips™ are sensor-equipped crutch attachments that measure real-time axial loading during ambulation. The devices connect via Bluetooth to a mobile application and deliver auditory and visual feedback to guide patients toward prescribed weight-bearing levels. The devices continuously record loading and step-count data for clinical monitoring and analysis.

PROCEDUREFinite Element Analysis (FEA)

Finite Element Analysis (FEA) is performed up to four times postoperatively to generate individualized weight-bearing prescriptions during rehabilitation. Simulations are based on CT scans and include segmentation and biomechanical modeling of the bone-fixator system. Assessments occur at: 7 days (baseline), 6 weeks, 12 weeks, and optionally at 16 weeks if healing isn't confirmed. Three regions are segmented: fixation system (screws and nail), bone fragments, and fracture gap. Materials: fixator (Titanium Grade 5), bone (mapped into cortical, trabecular, soft tissue, air), and fracture gap (early connective tissue). FEA calculates personalized safe loading based on: (1) Fixator safety (stress \< 290 MPa), (2) Interfragmentary motion (target: 0.5-2.0 mm), and (3) Strain in the fracture gap (octahedral: 0.001-0.05; hydrostatic: 0.001-0.02), supporting biological healing. Output informs weight-bearing prescriptions and step-count targets, delivered via Smart Crutch Tips™ with real-time fee

BEHAVIORALIterative walking

Participants will perform iterative walking sessions as part of their rehabilitation program. These sessions will be repeated throughout the day, with a minimum 2-hour rest interval between sessions. Step count will be progressively increased over time, according to the individualized rehabilitation plan. In the intervention arms, walking sessions will be guided by real-time auditory and visual feedback from Smart Crutch Tips™.

PROCEDURELower Limb Rehabilitation Exercise Program

A structured exercise program prescribed postoperatively to promote functional recovery after tibial shaft fracture surgery. Exercises target quadriceps, hamstrings, gluteal muscles, and ankle/foot mobility to maintain muscle tone, prevent stiffness, and improve circulation. The program includes isometric and dynamic exercises such as: static quadriceps and hamstring contractions, straight leg raises, hip abduction, knee extension, hamstring curls, heel slides, ankle dorsiflexion/plantarflexion, ankle inversion/eversion, ankle circles, toe spreading, and passive ankle stretching using a strap or towel. Exercises are performed in pain-free ranges with gradual progression in repetitions and sets according to the rehabilitation plan. Certain ankle and foot mobility exercises (dorsiflexion/plantarflexion) are also performed hourly during the day to prevent swelling and thrombosis.


Locations(18)

Kyiv City Clinical Hospital No. 1

Kyiv, Kyiv Oblast, Ukraine

Municipal Clinical Hospital No. 4 of the Dnipro City Counci

Dnipro, Ukraine

Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council

Dnipro, Ukraine

Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council

Dnipro, Ukraine

Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"

Dnipro, Ukraine

University Hospital of the Dnipro State Medical University

Dnipro, Ukraine

Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council"

Ivano-Frankivsk, Ukraine

Railway Clinical Hospital No. 1 of Kyiv Station

Kyiv, Ukraine

Kyiv City Clinical Hospital No. 17

Kyiv, Ukraine

Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine

Kyiv, Ukraine

Kyiv City Clinical Hospital No. 12

Kyiv, Ukraine

Kyiv City Clinical Hospital No. 7

Kyiv, Ukraine

Kyiv Regional Council "Kyiv Regional Clinical Hospital"

Kyiv, Ukraine

Kyiv City Clinical Hospital No. 9

Kyiv, Ukraine

Kyiv City Clinical Hospital No. 8

Kyiv, Ukraine

State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs"

Kyiv, Ukraine

Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"

Lviv, Ukraine

Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"

Lviv, Ukraine

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