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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 20, 2025

Primary Completion Date

June 1, 2026

Study Completion Date

December 15, 2026

Conditions
Fracture HealingTibial Fractures
Interventions
DEVICE

Smart 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.

PROCEDURE

Finite 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

BEHAVIORAL

Iterative 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™.

PROCEDURE

Lower 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.

Trial Locations (12)

49074

RECRUITING

Municipal Clinical Hospital No. 6 of the Dnipro City Counci, Dnipro

49102

RECRUITING

Municipal Clinical Hospital No. 4 of the Dnipro City Counci, Dnipro

02091

RECRUITING

Kyiv City Clinical Hospital No. 1, Kyiv

01030

NOT_YET_RECRUITING

Railway Clinical Hospital No. 1 of Kyiv Station, Kyiv

01133

NOT_YET_RECRUITING

Kyiv City Clinical Hospital No. 17, Kyiv

01601

NOT_YET_RECRUITING

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

02000

NOT_YET_RECRUITING

Kyiv City Clinical Hospital No. 12, Kyiv

03126

RECRUITING

Kyiv City Clinical Hospital No. 6, Kyiv

03179

RECRUITING

Kyiv City Clinical Hospital No. 7, Kyiv

04106

NOT_YET_RECRUITING

"Kyiv Regional Council Kyiv Regional Clinical Hospital", Kyiv

04112

NOT_YET_RECRUITING

Kyiv City Clinical Hospital No. 9, Kyiv

04201

RECRUITING

Kyiv City Clinical Hospital No. 8, Kyiv

All Listed Sponsors
lead

Comeback Mobility Inc

INDUSTRY

NCT07092579 - Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures | Biotech Hunter | Biotech Hunter