Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
NCT ID: NCT07092579
Last Updated: 2025-10-01
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-10-20
2026-12-15
Brief Summary
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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.
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Detailed Description
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The goal of the study is to determine whether providing precise, data-driven weight-bearing recommendations-delivered through Smart Crutch Tips™ with real-time visual and auditory feedback-can enhance fracture healing by promoting safe interfragmentary motion.
Group 1 (control - standard practice) will use Smart Crutch Tips™ for load data collection only, without feedback, and follow AO Foundation guidelines, progressing weight-bearing based on pain tolerance.
Group 2 (controlled mechanical stimulation) will receive personalized FEA-based load prescriptions for optimal interfragmentary motion, with real-time audio/visual feedback from Smart Crutch Tips™. They will perform iterative walking sessions (minimum two-hour rest between), gradually increasing steps per their plan, plus prescribed lower limb strengthening exercises.
Group 3 (optimized stimulation per Claes-Heigele theory) will receive FEA-based prescriptions targeting maximum fracture-zone voxel optimization, with real-time feedback. They will follow the same walking and exercise protocol as Group 2.
Participants will use ComeBack Mobility Smart Crutch Tips™ all the time they use crutches in an outpatient setting for up to 24 weeks, depending on their healing progress. These devices provide real-time guidance to help users stay within their prescribed weight-bearing range and transmit data to a centralized monitoring platform.
Participants will attend seven in-person follow-up visits: screening (Day 0-7), and then at 6, 12, 16, 20, 24, and 36 weeks after surgery. Аt each follow-up visit starting from Visit 1 (6 weeks) Radiographic assessments (X-ray) will be performed to monitor fracture healing, Computed tomography (CT) scans will be conducted only at specific time points: during the screening period (0-7 days post-surgery), and prior to Visit 1 (6 weeks), Visit 2 (12 weeks), and optional prior to Visit 3 (16 weeks) to adjust weight-bearing prescription and assess consolidation dynamics. Clinical data will be collected via the ComeBack Mobility app and electronic case report forms (eCRFs).
Before each follow-up visit, participants will complete an online diary that includes validated questionnaires such as the Tampa Scale for Kinesiophobia (TSK-17) and the Lower Extremity Functional (LEFS). At Visit 1, participants will also complete the System Usability Scale (SUS) to assess their experience using the device.
All study procedures will be conducted according to a standardized research protocol across multiple orthopedic hospitals and trauma centers in Ukraine, ensuring consistency in surgical technique, data collection, and follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Group (Standard of Care)
Participants will follow the standard-of-care postoperative weight-bearing protocol according to AO Foundation clinical guidelines: "Partial weight-bearing with crutches is started as soon as the patient is able. Unrestricted weight bearing should be delayed until fracture callus is visible, fibular healing is evident, and weight bearing is without pain. Depending on the consolidation, weight bearing can usually be increased after 6-8 weeks, with full weight-bearing when the fracture has healed." Smart Crutch Tips™ will be used in passive mode, with all notifications (audio and visual) disabled. Participants will not have access to any feedback regarding their weight-bearing. The devices will serve solely for data collection purposes, recording step count and applied loading during ambulation.
No interventions assigned to this group
Controlled Mechanical Stimulation and Activity (Optimal Interfragmentary Motion)
Participants will receive individualized weight-bearing prescriptions derived from finite element analysis (FEA) of their postoperative CT scan, targeting optimal interfragmentary motion at the fracture site.
Smart Crutch Tips™ will provide real-time audio and visual feedback to support adherence to the prescribed loading and activity program.
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.
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
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™.
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.
Controlled Mechanical Stimulation and Activity According to the Claes-Heigele Theory
Participants will receive individualized weight-bearing prescriptions derived from finite element analysis (FEA) of their postoperative CT scan, aimed at achieving the highest percentage of voxels in the fracture zone in accordance with the theory of L.E. Claes and C.A. Heigele (1999).
Smart Crutch Tips™ will provide real-time audio and visual feedback to support adherence to the prescribed loading and activity program.
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.
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
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™.
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.
Interventions
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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.
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
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™.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age: 18 to 60 years for both males and females (pre-menopausal).
3. Body weight between 40 and 120 kg.
4. Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
5. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 42-A, 42-B, or 42-C) requiring surgical treatment.
6. Fracture treated exclusively with intramedullary nailing (intramedullary fixation without additional plates or external fixation).
7. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
8. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
9. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
10. Enrollment within 48 hours following surgical intervention.
11. Alcohol consumption (up to 2-3 times per week) within acceptable limits.
12. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 16, 20, 24 and 36 after surgery.
Exclusion Criteria
2. Fractures classified as 43-B or 43-C according to AO/OTA.
3. Chronic alcoholism (defined as \>14 standard drinks per week for men or \>7 for women).
4. Presence of metabolic disorders, including uncontrolled thyroid dysfunction, severe renal or hepatic pathology.
5. Pathological fractures associated with osteoporosis, osteomyelitis, tumors, metastases, or rickets.
6. Lower-limb contractures with functional impairment of grade II or higher.
7. Pregnancy or intention to conceive during the study period.
8. Psychiatric, cognitive, or neurological disorders that may interfere with adherence to the rehabilitation protocol or effective communication with the study team.
9. Clinically significant heart failure (including chronic or acute, with an ejection fraction \<40% or with symptoms such as edema, dyspnea at rest, or orthopnea).
10. 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.
11. 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).
12. Diagnosed epilepsy or other seizure disorders not fully controlled by medication.
13. Progressive neurodegenerative diseases (e.g., amyotrophic lateral sclerosis, Huntington's disease, dementia).
14. Any sensory, balance, or vestibular disorders that may impair safe use of the investigational device.
15. Participation in another clinical study within the past 6 months that could affect the results of the current study.
16. Ongoing or planned use of medications known to affect bone healing.
18 Years
60 Years
ALL
No
Sponsors
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Comeback Mobility Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Vaida Glatt, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Health
Locations
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Kyiv City Clinical Hospital No. 1
Kyiv, Kyiv Oblast, Ukraine
Municipal Clinical Hospital No. 6 of the Dnipro City Counci
Dnipro, , Ukraine
Municipal Clinical Hospital No. 4 of the Dnipro City Counci
Dnipro, , 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. 6
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CBM-UA-2025/1
Identifier Type: -
Identifier Source: org_study_id
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