Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT07138066
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal Tibia Fractures
Sponsor:
Comeback Mobility Inc
Organization:
Study Overview
Official Title:
Study of Individual Weight-bearing and Iterative Walking Using "ComeBack Mobility" Smart Crutch Tips for Mechanical Stimulation of Extra-articular Distal Tibia Fracture Healing
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 extra-articular distal tibia 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? 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.
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.
Detailed Description:
This is a pilot multicenter clinical trial designed to explore the impact of individualized weight-bearing regimens and iterative walking protocols on the healing of extra-articular distal tibia fractures. The study will enroll 30 adult participants (aged 18-60) with closed distal tibia fractures (AO/OTA 43- А1, 43-А2, 43-А3) treated with plates. Participants will be allocated into three parallel groups (ten participants per group).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: