Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
NCT ID: NCT07138066
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-09-29
2026-07-15
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? Researchers will compare standard rehabilitation, AO Foundation-based recommendations, and personalized weight-bearing programs derived from finite element analysis (FEA) to determine which approach 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 eight 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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Group 1 - Control (Standard Practice):
During the first six to ten weeks, participants will not load the operated leg. After this period, they will gradually increase weight-bearing within pain tolerance. Smart Crutch Tips™ will be used with indicators turned off (data collection only, without feedback).
Group 2 - AO Foundation Recommendations:
Participants will be allowed partial weight-bearing (touchdown or 10-20 kg load) with crutches or walkers according to AO Foundation guidelines. Smart Crutch Tips™ will be used with indicators turned on, providing real-time feedback on loading level.
Group 3 - FEA-Based Personalized Loading:
Participants will receive individualized axial loading prescriptions developed using finite element analysis (FEA). Smart Crutch Tips™ will be used with visual and auditory real-time feedback. In addition to personalized loading, participants will follow an iterative walking protocol. Participants will also perform a set of isometric and dynamic exercises to strengthen the lower limb muscles
Study Objectives:
The primary aim is to determine whether providing precise, data-driven weight-bearing recommendations-delivered via Smart Crutch Tips™ with real-time visual and auditory feedback-can enhance fracture healing by promoting safe interfragmentary motion.
Device Use and Follow-Up:
Participants will use ComeBack Mobility Smart Crutch Tips™ whenever 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 eight in-person follow-up visits: screening (Day 0-7) and then at 6, 12, 15, 18, 21, 24, and 36 weeks post-surgery. At 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 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 optionally prior to Visit 3 (15 weeks), to adjust weight-bearing prescriptions and assess consolidation dynamics.
Data Collection:
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 Scale (LEFS).
Standardization Across Sites:
All study procedures will follow a standardized research protocol implemented across multiple orthopedic hospitals and trauma centers in Ukraine to ensure 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)
Patients in this group receive standard clinical recommendations for weight-bearing progression without the use of digital monitoring tools, specifically six to ten weeks of non-weight-bearing. Axial loading instructions are provided by the treating physician based on clinical examination and radiographic findings. The decision to initiate full weight-bearing is made individually, without objective device-based monitoring. However, patients in this group are provided with Smart Crutch Tips™ that passively monitor gait parameters without providing visual or auditory cues. This allows the collection of adherence data without interfering with the clinical process. Such an approach reflects real-world clinical practice and serves as a comparator for evaluating the effectiveness of personalized strategies.
No interventions assigned to this group
Controlled Mechanical Stimulation According to AO Guidelines
Participants in this group receive recommendations for weight-bearing progression in accordance with AO guidelines (10-20 kg load). Axial loading is monitored in real time using Smart Crutch Tips™, which provide visual and auditory feedback.
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 15 weeks. 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
Orthopedic shoes for use during rehabilitation period
Patients are provided with orthopedic shoes to be worn during the rehabilitation period (up to 6-10 weeks).
Personalized Controlled Mechanical Stimulation (FEA)
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 15 weeks. 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.
Lower Limb Rehabilitation Exercise Program
The program consists of a structured set of isometric and dynamic exercises targeting the quadriceps, hamstrings, gluteal muscles, and ankle/foot mobility. Exercises are performed in a supine, prone, or seated position, as appropriate, with 2 sets of 5-12 repetitions or sustained holds of 20-30 seconds, progressing gradually according to the rehabilitation plan. All movements are conducted within a pain-free range (not exceeding 4/10 on the VAS scale), with additional hourly ankle mobility work prescribed to reduce swelling and prevent thrombosis.
Orthopedic shoes for use during rehabilitation period
Patients are provided with orthopedic shoes to be worn during the rehabilitation period (up to 6-10 weeks).
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 15 weeks. 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.
Lower Limb Rehabilitation Exercise Program
The program consists of a structured set of isometric and dynamic exercises targeting the quadriceps, hamstrings, gluteal muscles, and ankle/foot mobility. Exercises are performed in a supine, prone, or seated position, as appropriate, with 2 sets of 5-12 repetitions or sustained holds of 20-30 seconds, progressing gradually according to the rehabilitation plan. All movements are conducted within a pain-free range (not exceeding 4/10 on the VAS scale), with additional hourly ankle mobility work prescribed to reduce swelling and prevent thrombosis.
Orthopedic shoes for use during rehabilitation period
Patients are provided with orthopedic shoes to be worn during the rehabilitation period (up to 6-10 weeks).
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. Diagnosed with a closed tibial shaft fracture (AO/OTA classification: 43- А1, 43-А2, 43-А3) requiring surgical treatment.
5. Fracture treated exclusively with plates
6. No diabetes or well-controlled diabetes (HbA1c ≤ 7.0%).
7. Ability to use crutches without losing balance and medically cleared for partial weight-bearing on the operated limb.
8. Willingness to adhere to the prescribed weight-bearing protocol using the Smart Crutch Tips™ device.
9. Enrollment within 48 hours following surgical intervention.
10. Alcohol consumption (up to 2-3 times per week) within acceptable limits.
11. Willingness to comply with all study procedures, including follow-up visits at weeks 1, 6, 12, 15, 18, 21, 24, and 36 after surgery.
Exclusion Criteria
2. Fractures classified as 41-A, 41-B, or 42 -A,B 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
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-WB -2025/2
Identifier Type: -
Identifier Source: org_study_id
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