NCT07289828

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 4, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

predictionankle injuryknee injuryinertial sensorartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • IMU data

    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).

    at baseline

Secondary Outcomes (3)

  • questionnaire injuries lower extremity

    Baseline

  • questionnaire sports activity

    Baseline

  • questionnaire prevention

    baseline

Study Arms (1)

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.

Other: IMU Data collectionOther: Questionnaire

Interventions

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).

test group

On the day of the examination, the test subjects completed a standardized questionnaire on previous injuries, type of sport, sporting activity, and preventive measures.

test group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sport students at TUM School of Medicine and Health

You may qualify if:

  • Subjectively healthy participants
  • Age: \>18 years and under 60 years
  • German language skills sufficient to follow the exercise instructions and complete the questionnaires

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUM University Hospital

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Ankle InjuriesKnee Injuries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rüdiger von Eisenhart-Rothe, Prof. Dr. med.

    Department of Orthopaedics and Sports Orthopaedics, TUM University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

January 29, 2024

Primary Completion

June 4, 2024

Study Completion

June 4, 2024

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

IDP is not permitted due to data protection regulations.

Locations