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

April 11, 2026 updated by: Comeback Mobility Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a pilot multicenter clinical trial designed to explore the impact of individual weight-bearing and iterative walking regimens on the healing of tibial shaft fractures. The study will enroll 30 adult participants (aged 18 to 80) with closed tibial shaft fractures (AO/OTA 42-A, 42-B, or 42-C) treated by intramedullary nailing and/or plate fixation. Participants will be allocated into three parallel groups (ten participants per group), two of whom will receive personalized weight-bearing protocols based on finite element analysis (FEA) performed using individual CT scan data.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Ukraine
      • Dnipro, Ukraine, 49102
        • Recruiting
        • Municipal Clinical Hospital No. 4 of the Dnipro City Counci
        • Contact:
        • Principal Investigator:
          • Oleksii Altanets
        • Sub-Investigator:
          • Serhii Shcherbak
      • Dnipro, Ukraine
        • Recruiting
        • Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council
        • Contact:
        • Principal Investigator:
          • Vasyl Makarov, PhD
        • Sub-Investigator:
          • Valerii Lytvyn
      • Dnipro, Ukraine
        • Recruiting
        • Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council
        • Contact:
      • Dnipro, Ukraine
        • Recruiting
        • Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"
        • Contact:
      • Dnipro, Ukraine
        • Recruiting
        • University Hospital of the Dnipro State Medical University
        • Contact:
      • Ivano-Frankivsk, Ukraine
        • Recruiting
        • Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council"
        • Contact:
      • Kyiv, Ukraine, 01030
        • Not yet recruiting
        • Railway Clinical Hospital No. 1 of Kyiv Station
        • Contact:
          • Oleh Lehenkyi
          • Phone Number: +380503803958
          • Email: legenky@i.ua
        • Principal Investigator:
          • Oleh Lehenkyi
      • Kyiv, Ukraine, 01601
        • Not yet recruiting
        • Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine
        • Contact:
        • Principal Investigator:
          • Oleksii Sulyma
        • Sub-Investigator:
          • Volodymyr Chornyi
        • Sub-Investigator:
          • Yevhen Kozik
      • Kyiv, Ukraine, 03179
        • Recruiting
        • Kyiv City Clinical Hospital No. 7
        • Contact:
        • Principal Investigator:
          • Oleksandr Rozsokha
        • Sub-Investigator:
          • Serhii Demchuk
        • Sub-Investigator:
          • Oleksandr Polyakov
      • Kyiv, Ukraine, 04201
        • Recruiting
        • Kyiv City Clinical Hospital No. 8
        • Contact:
        • Principal Investigator:
          • Viktoriia Ladyka
        • Sub-Investigator:
          • Yevhen Drevel
      • Kyiv, Ukraine, 04112
        • Recruiting
        • Kyiv City Clinical Hospital No. 9
        • Contact:
        • Principal Investigator:
          • Pavlo Honcharuk
      • Kyiv, Ukraine
        • Recruiting
        • State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs"
        • Contact:
      • Kyiv, Ukraine, 01133
        • Recruiting
        • Kyiv City Clinical Hospital No. 17
        • Contact:
        • Principal Investigator:
          • Maksym Cherniienko
      • Kyiv, Ukraine, 02000
        • Recruiting
        • Kyiv City Clinical Hospital No. 12
        • Contact:
        • Principal Investigator:
          • Taras Kasianchuk
      • Kyiv, Ukraine, 04106
        • Recruiting
        • Kyiv Regional Council "Kyiv Regional Clinical Hospital"
        • Principal Investigator:
          • Vadym Roienko
        • Contact:
      • Lviv, Ukraine
        • Recruiting
        • Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
        • Contact:
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ukraine, 02091
        • Recruiting
        • Kyiv City Clinical Hospital No. 1
        • Contact:
        • Principal Investigator:
          • Oleksandr Martynchuk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent was provided after being fully informed about participation in the study.
  2. Age: 18 to 80 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 and/or plate 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.
  13. Patients with fractures extending into the articular surface of the distal tibial epiphysis may be included, provided that the fracture is deemed stable

Exclusion Criteria:

  1. Presence of open or high-energy fractures, multiple lower-limb fractures, or use of bone grafts.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Experimental: 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.
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™.
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.
Other Names:
  • ComeBack Mobility Smart Crutch Tips
  • Smart Crutches,
  • CBM Smart Tips
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
Other Names:
  • FE Modeling
  • Biomechanical Modeling
  • Postoperative Structural Simulation
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.
Experimental: 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.
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™.
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.
Other Names:
  • ComeBack Mobility Smart Crutch Tips
  • Smart Crutches,
  • CBM Smart Tips
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
Other Names:
  • FE Modeling
  • Biomechanical Modeling
  • Postoperative Structural Simulation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Radiographic Fracture Union
Time Frame: 12 - 24 weeks post-surgery ± 7 days

X-rays will be performed at Visit 1, Visit 2, Visit 3, Visit 4, Visit 5 and Visit 6 postoperatively. CT will be conducted at Visit 0, Visit 1, Visit 2, and optionally at Visit 3 to assess fracture union progression and load adaptation.

Fracture Consolidation Assessment Procedure:

CT and X-ray data will be evaluated separately. CT criteria include qualitative parameters (fracture line presence, edge clarity, cortical bridging) and quantitative parameters (Hounsfield units at the fracture site). Radiographic assessment will follow the modified RUST scale:

Score 1 - no callus, visible line; Score 2 - callus without bridging, visible line; Score 3 - callus with bridging, visible line; Score 4 - callus with bridging, no visible line. The total score ranges from 4 to 16. Fracture is united if at least three cortices are bridged. Delayed union is defined as a visible fracture line and no callus after 3 months.
12 - 24 weeks post-surgery ± 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to Prescribed Axial Loading
Time Frame: from 0 to 36 weeks post-surgery
The percentage of steps taken within the prescribed range of axial loading. Higher percentages indicate better adherence to the prescribed loading regimen. This is measured through continuous monitoring using the Smart Crutch Tips™ device and analyzed at each follow-up visit (from 0 to 36 weeks).
from 0 to 36 weeks post-surgery
Lower Extremity Functional Status (LEFS)
Time Frame: 0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Assessed using the Lower Extremity Functional Scale (LEFS) - a validated instrument designed to measure a patient's ability to perform everyday physical activities involving the lower limbs. The questionnaire consists of 20 items, each scored from 0 (extreme difficulty or unable to perform) to 4 (no difficulty). The total score ranges from 0 to 80, with higher scores indicating better functional status.
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Recording of AEs/SAEs AR/SAAR/SUSARs, including Postoperative Complications
Time Frame: 0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)

The following types of postoperative complications will be recorded and analyzed:

residual pain; delayed union; nonunion; malunion; implant failure; need for reoperation. Assessment will be performed clinically at each visit and supplemented with radiological evaluation (X-ray and CT), according to the visit schedule.

All adverse events (AEs), serious adverse events (SAEs), adverse reactions (ARs), serious adverse reactions (SAARs), and suspected unexpected serious adverse reactions (SUSARs) identified during the study will also be recorded, described, and analyzed.
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Pain Level
Time Frame: 0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Assessed using the Visual Analogue Scale (VAS), presented electronically as a continuous line ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity. Assessment is conducted at each follow-up visit
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Fear of Movement (TSK-17)
Time Frame: 0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
Assessed using the Tampa Scale for Kinesiophobia, 17-item version (TSK-17), which evaluates fear of physical activity due to pain or risk of re-injury. Scores range from 17 to 68, with higher scores indicating greater fear of movement. Administered electronically at each follow-up visit.
0-7 days post-surgery and at 6, 12, 16, 20, 24, 36 weeks after surgery (+- 7 days)
mRUST Score
Time Frame: at 6, 12, 16, 20, 24, and 36 weeks after surgery (+- 7 days)
The modified Radiographic Union Scale for Tibial fractures (mRUST) is used to assess bone healing based on radiographs of the fracture site. Four cortices are evaluated, with scores assigned according to callus formation and visibility of the fracture line. The total score ranges from 4 to 16, with higher scores indicating more advanced bone healing. mRUST scores will be compared between intervention and control groups at each follow-up visit to determine the impact of the intervention on bone healing.
at 6, 12, 16, 20, 24, and 36 weeks after surgery (+- 7 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device Usability (System Usability Scale, SUS)
Time Frame: Week 6 post-surgery
Assessment of Smart Crutch Tips™ usability, reliability, and patient satisfaction using the validated SUS questionnaire.
Week 6 post-surgery
Time to Full Weight-Bearing (FWB)
Time Frame: From surgery until full weight-bearing, assessed up to 24 weeks
Time to full axial loading on the injured limb will be assessed using both clinical evaluation and finite element analysis (FEA). The measure reflects the time required for participants to achieve full weight-bearing. Assessment will be performed during follow-up visits (evaluation of pain, mobility, swelling, radiological confirmation) or via the CBM system (three consecutive days without crutches/cane and without complications, confirmed at a follow-up visit). The variable is measured on a ratio scale.
From surgery until full weight-bearing, assessed up to 24 weeks
Analgesic Consumption
Time Frame: At all follow-up visits up to 36 weeks
Recorded use of analgesics (yes/no) during scheduled clinical visits.
At all follow-up visits up to 36 weeks
Psychotherapy Visits
Time Frame: From surgery through 36 weeks
Number of psychotherapy visits recorded during follow-up
From surgery through 36 weeks
Antidepressant Consumption
Time Frame: At all follow-up visits up to 36 weeks
Recorded use of antidepressants (yes/no) during scheduled clinical visits.
At all follow-up visits up to 36 weeks
Internal Fixation Safety Level (IFSL)
Time Frame: From surgery through 36 weeks
Impact of the CBM method on internal fixation stability assessed via finite element analysis (FEA) using Smart Crutch Tips™ loading data. Measurement scale: interval level.
From surgery through 36 weeks
Ankle Range of Motion (Goniometry)
Time Frame: At all follow-up visits up to 36 weeks
Dorsiflexion (0-20°) and plantarflexion (0-50°) measured using a goniometer following standard methodology; results compared between groups at each follow-up
At all follow-up visits up to 36 weeks
Subtalar Range of Motion (Goniometry)
Time Frame: At all follow-up visits up to 36 weeks
Inversion (0-20°) and eversion (0-10°) measured using a goniometer following standard methodology; results compared between groups at each follow-up.
At all follow-up visits up to 36 weeks
Knee Range of Motion (Goniometry)
Time Frame: At all follow-up visits up to 36 weeks
Flexion (0-135°) and extension (0° to -5° hyperextension possible) measured using a goniometer following standard methodology; results compared between groups at each follow-up
At all follow-up visits up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Comeback Mobility Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vaida Glatt, PhD, UT Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBM-UA-2025/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Time to radiographic fracture union (primary endpoint)

mRUST scores at predefined time points

Compliance data on axial loading collected by Smart Crutch Tips™

Functional recovery outcomes (LEFS, TSK-17 questionnaire responses)

Pain level assessments (VAS)

Adverse event data, including AEs, SAEs, ADEs, SADEs, and device deficiencies

Gait adherence metrics derived from the CBM mobile app

Baseline demographic and clinical information relevant to fracture type and healing (e.g., fracture classification, BMI, CT-derived FEA data)

IPD Sharing Time Frame

IPD and supporting documentation will be made available six months after the publication of the primary results. Data will remain accessible for at least 3 years from that date.

IPD Sharing Access Criteria

Access to IPD will be granted to qualified researchers affiliated with academic, clinical, or non-profit institutions conducting methodologically sound analyses that align with the objectives of the original study or explore related hypotheses. Requests must include a research proposal, analysis plan, and ethical approval if applicable. All requests will be reviewed by the study's principal investigator and sponsor team based on scientific merit and compliance with data privacy standards.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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