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.
Comeback Mobility Inc
30 participants
Oct 28, 2025
INTERVENTIONAL
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
Inclusion Criteria13
- Signed informed consent was provided after being fully informed about participation in the study.
- Age: 18 to 80 years for both males and females (pre-menopausal).
- Body weight between 40 and 120 kg.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
- Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
- Fracture treated exclusively with intramedullary nailing and/or plate fixation
- No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
- Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
- Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
- Enrollment within 48 hours following surgical intervention.
- Alcohol consumption (up to 2-3 times per week) within acceptable limits.
- Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.
- Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable
Exclusion Criteria16
- Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
- Fractures classified as 43-B or 43-C according to AO/OTA.
- Chronic alcoholism (defined as >14 standard drinks per week for men or >7 for women).
- Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
- Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.
- Lower-limb contractures with functional impairment of grade II or higher.
- Pregnancy or intention to conceive during the study period.
- Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.
- Clinically significant heart failure (including chronic or acute, with an ejection fraction <40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
- Pulmonary insufficiency of any origin, accompanied by chronic hypoxemia (PaO₂ < 60 mmHg) or hypercapnia (PaCO₂ > 45 mmHg), requiring oxygen support or significantly limiting physical activity.
- Clinically significant neurological disorders that may affect motor function, coordination, or physical activity (e.g., stroke with residual deficits, Parkinson's disease, multiple sclerosis, cerebral palsy).
- Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
- Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
- Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
- Participation in another clinical study within the past 6 months that could affect the results of the current study.
- Ongoing or planned use of medications known to affect bone healing.
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Interventions
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.
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
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™.
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)
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NCT07092579