- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289828
Prediction of Lower Extremity Injuries Using Lower Limb-worn Inertial Measurement Units (PredKnee)
Prediction of Pre-existing Lower Extremity Injuries Using Lower Limb-worn Inertial Measurement Units
This study analyses questionnaires and inertial sensor data from 108 sports science students regarding previous lower extremity injuries, sports activity, and preventive measures, combined with the prospective development of an AI-based prediction algorithm.
Inertial sensor data were collected during walking and running on a standard 400 m track, with sensors placed on the thighs and ankles, and heart rate recorded via smartwatch. Participants also completed questionnaires on previous injuries, comorbidities, sports activity, and prevention.
The aim is to use the anonymized data to identify gait and running patterns associated with prior knee and ankle injuries using AI analysis, and to correlate these findings with sports activity and preventive measures.
Hypothesis: Prior lower extremity injuries leave specific gait and running patterns detectable by inertial sensors and AI-based analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, analysis of questionnaires and inertial sensor data from 108 sports science students is conducted with regard to previous injuries of the lower extremities, their sports activities, and a possible association with performed preventive measures, along with the prospective development of an AI-based prediction algorithm to detect prior injuries of the lower extremities.
In all participants, inertial sensor data were collected during walking and running on a defined track (5 minutes walking, 5 minutes running, 5 minutes walking on a standard 400 m oval tartan track). Sensors were placed on the lateral aspects of both thighs above the knee joint and on the lateral aspects of both ankles above the lateral malleolus. In addition, participants wore a smartwatch on the left wrist to record heart rate. Furthermore, participants completed questionnaires regarding previous injuries, comorbidities, sports activity, and preventive measures undertaken.
The aim of the current analysis is to utilize the anonymized data from questionnaires and inertial sensors to identify gait and running patterns indicative of previous injuries of the lower extremities (knee and ankle) by means of an AI algorithm, and to correlate these findings with reported sports activities and preventive measures.
Hypothesis: Previous injuries of the lower extremities (particularly of the knee and ankle) result in specific gait and running patterns measurable by inertial sensors, which can be identified through AI-based analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bavaria
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Munich, Bavaria, Germany, 81675
- TUM University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjectively healthy participants
- Age: >18 years and under 60 years
- German language skills sufficient to follow the exercise instructions and complete the questionnaires
Exclusion Criteria:
- Age <18 years or >60 years
- Recent injuries and trauma to the lower extremities (less than 6 months ago)
- Acute malignant disease
- Acute inflammatory disease
- Lack of German language skills
- Lack of cardiopulmonary endurance for testing
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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test group
All participants were sports students at TUM School of Medicine and Health.
Of all participants, inertial sensor data were collected during walking and running on a defined track (5 minutes walking, 5 minutes running, 5 minutes walking on a standard 400 m oval tartan track).
All participants completed questionnaires regarding previous injuries, comorbidities, sports activity, and preventive measures undertaken.
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Participants were walking and running while wearing inertial measurement units (IMU) on both legs.
The IMUs (MetaMotionS sensor by Mbientlab) where recording at 100Hz (accelerometer and gyroscope) and 25Hz (magnetometer).
On the day of the examination, the test subjects completed a standardized questionnaire on previous injuries, type of sport, sporting activity, and preventive measures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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IMU data
Time Frame: at baseline
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Time-stamped, unfiltered, device-coordinate-based 3-axis IMU data (Ax, Ay, Az) from four IMUs, placed laterally on both thighs (above the knee joint) and on both ankles (above the lateral malleolus).
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at baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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questionnaire injuries lower extremity
Time Frame: Baseline
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Participants reported previous injuries and illnesses affecting the lower extremities on a standardized questionnaire.
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Baseline
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questionnaire sports activity
Time Frame: Baseline
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Participants indicated their sport and intensity level on a standardized questionnaire.
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Baseline
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questionnaire prevention
Time Frame: baseline
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Participants indicated on a standardized questionnaire whether preventive measures to avoid sports injuries were being implemented.
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rüdiger von Eisenhart-Rothe, Prof. Dr. med., Department of Orthopaedics and Sports Orthopaedics, TUM University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KneeInjuryPred
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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