Actively Recruiting
Study of Individual Weight-bearing and Iterative Walking Using Smart Crutch Tips for Mechanical Stimulation of Tibial Shaft Fracture Healing
Led by Comeback Mobility Inc · Updated on 2026-04-14
30
Participants Needed
18
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine whether personalized weight-bearing prescriptions using Smart Crutch Tips2 can improve recovery after surgery for tibial shaft fractures. It evaluates if a weight-bearing program based on CT scans and biomechanical analysis can promote faster fracture healing, earlier full weight-bearing, reduced fear of movement, and better outcomes. The trial compares standard rehabilitation to two types of personalized weight-bearing programs in adult patients with surgically treated tibial shaft fractures. Participants are divided into three groups: one follows standard care with Smart Crutch Tips2 used only for data collection without feedback; the other two receive personalized weight-bearing prescriptions derived from finite element analysis of their CT scans. These two groups use Smart Crutch Tips2 to receive real-time audio and visual feedback during walking and follow a specific rehabilitation plan including iterative walking sessions and lower limb strengthening exercises. The devices are used for up to 24 weeks or as needed during outpatient crutch use. Participants attend seven in-person visits from screening up to 36 weeks post-surgery, including clinical exams, X-rays, and CT scans at specified time points to monitor healing and adjust prescriptions. They complete online questionnaires assessing pain, activity, and fear of movement, and provide usability feedback on the device. Data is continuously collected through the Smart Crutch Tips2 and a mobile app to track adherence and outcomes. The primary measure is time to fracture union between 12 and 24 weeks post-surgery.
CONDITIONS
Brief Title
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent after full study information.
- Age between 18 and 80 years, male or female (pre-menopausal).
- Body weight between 40 and 120 kg.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
- Closed tibial shaft fracture (AO/OTA 42-A, 42-B, or 42-C) requiring surgery.
- Fracture treated only with intramedullary nailing and/or plate fixation.
- No diabetes or well-controlled diabetes (HbA1c 7.0%).
- Ability to safely use crutches and medically cleared for partial weight-bearing.
- Willingness to follow weight-bearing protocol using Smart Crutch Tips2.
- Enrollment within 48 hours after surgery.
- Alcohol consumption within acceptable limits (up to 2-3 times per week).
- Commitment to all study procedures and follow-up visits.
- Stable fractures extending into distal tibial epiphysis allowed if deemed stable.
You will not qualify if you...
- Open or high-energy fractures, multiple lower-limb fractures, or bone graft use.
- Fractures classified as AO/OTA 43-B or 43-C.
- Chronic alcoholism exceeding defined limits.
- Metabolic disorders including uncontrolled thyroid, severe kidney or liver disease.
- Pathological fractures from osteoporosis, infection, tumors, metastases, or rickets.
- Lower-limb contractures with moderate or severe functional impairment.
- Pregnancy or plans to conceive during the study.
- Psychiatric, cognitive, or neurological disorders affecting protocol adherence.
- Significant heart failure with low ejection fraction or symptoms.
- Lung insufficiency with chronic low oxygen or high carbon dioxide levels.
- Neurological disorders affecting motor function or coordination.
- Uncontrolled epilepsy or seizure disorders.
- Progressive neurodegenerative diseases.
- Sensory, balance, or vestibular disorders impairing safe device use.
- Participation in another clinical study within 6 months affecting results.
- Use of medications that affect bone healing ongoing or planned.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 0 to 7 days post-surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks depending on healing progress
Participants use Smart Crutch Tips™ with or without real-time feedback to guide weight-bearing and iterative walking sessions based on individualized protocols or standard care. Participants also perform prescribed lower limb rehabilitation exercises. This phase supports fracture healing with ongoing monitoring and adjustment of weight-bearing prescriptions.
Participants attend 6 scheduled in-person visits at 6, 12, 16, 20, 24, and 36 weeks post-surgery and complete online diaries before each visit
Duration - Up to 36 weeks post-surgery
Participants continue fracture healing assessments through radiographic imaging and clinical evaluations to monitor recovery after the active treatment phase ends.
Included in the scheduled visits at 24 and 36 weeks post-surgery
Trial Site Locations
Total: 18 locations
1
Kyiv City Clinical Hospital No. 1
Kyiv, Kyiv Oblast, Ukraine, 02091
Actively Recruiting
2
Municipal Clinical Hospital No. 4 of the Dnipro City Counci
Dnipro, Ukraine, 49102
Actively Recruiting
3
Communal Non-Profit Enterprise "Regional Family Health Medical Center" of the Dnipropetrovsk Regional Council
Dnipro, Ukraine
Actively Recruiting
4
Municipal Non-Profit Enterprise "City Clinical Hospital No. 16" of the Dnipro City Council
Dnipro, Ukraine
Actively Recruiting
5
Municipal Non-Profit Enterprise of the Dnipro Regional Council "Dnipro Regional Clinical Hospital named after Mechnikov"
Dnipro, Ukraine
Actively Recruiting
6
University Hospital of the Dnipro State Medical University
Dnipro, Ukraine
Actively Recruiting
7
Municipal Non-Profit Enterprise "Ivano-Frankivsk Regional Clinical Hospital of the Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ukraine
Actively Recruiting
8
Railway Clinical Hospital No. 1 of Kyiv Station
Kyiv, Ukraine, 01030
Not Yet Recruiting
9
Kyiv City Clinical Hospital No. 17
Kyiv, Ukraine, 01133
Actively Recruiting
10
Institute of Traumatology and orthopedics of the national academy of medical sciences of Ukraine
Kyiv, Ukraine, 01601
Not Yet Recruiting
11
Kyiv City Clinical Hospital No. 12
Kyiv, Ukraine, 02000
Actively Recruiting
12
Kyiv City Clinical Hospital No. 7
Kyiv, Ukraine, 03179
Actively Recruiting
13
Kyiv Regional Council "Kyiv Regional Clinical Hospital"
Kyiv, Ukraine, 04106
Actively Recruiting
14
Kyiv City Clinical Hospital No. 9
Kyiv, Ukraine, 04112
Actively Recruiting
15
Kyiv City Clinical Hospital No. 8
Kyiv, Ukraine, 04201
Actively Recruiting
16
State Institution "Feofaniya Clinical Hospital of the State Administration of Affairs"
Kyiv, Ukraine
Actively Recruiting
17
Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
Lviv, Ukraine
Actively Recruiting
18
Municipal Non-Profit Enterprise "Lviv Territorial Medical Association" "Multidisciplinary Clinical Hospital for Intensive Treatment Methods and Emergency Medical Care"
Lviv, Ukraine
Actively Recruiting
Research Team
N
Nataliia Popova
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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