NCT03840551: BIOS-ACL

Definition of Biomechanical Indices Measurable During Sport Movements for the Prevention of Primary and Secondary ACL Injury

Completed NA Last updated 10 February 2021

What this trial tests

NA trial testing Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS) in Sport Injury in 34 participants. Completed in 1 October 2020.

Timeline

15 December 2018

Primary endpoint
10 August 2019

1 October 2020

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	34
Start date	15 December 2018
Primary completion	10 August 2019
Estimated completion	1 October 2020
Sites	1 location across Italy

Drugs / interventions tested

• Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)

Conditions studied

• Sport Injury — all drugs for Sport Injury →
• Anterior Cruciate Ligament Injury — all drugs for Anterior Cruciate Ligament Injury →
• Biomechanical; Lesion — all drugs for Biomechanical; Lesion →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 50, any sex, with Sport Injury or Anterior Cruciate Ligament Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the study is to define a set of quantitative parameters related to articular biomechanics, which will be evaluated during some specific motor tasks. The goal is the prevention of primary and secondary anterior cruciate ligament injury in athletes.

Specifically, the validation of a new comparative methodology of biomechanics analysis will be performed, based on inertial sensors and musculoskeletal models. This way, brief but exhaustive description of functional characteristics of athletes could be created and easily used in ambulatory environment.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rehabilitation and Return to Sport Assessment after Anterior Cruciate Ligament Injury: Quantifying Joint Kinematics during Complex High-Speed Tasks through Wearable Sensors.
   Di Paolo S, Lopomo NF, Della Villa F, Paolini G, et al · · 2021 · cited 40× · PMID 33810610 · DOI 10.3390/s21072331
2. A 2D video-analysis scoring system of 90° change of direction technique identifies football players with high knee abduction moment.
   Della Villa F, Di Paolo S, Santagati D, Della Croce E, et al · · 2022 · cited 23× · PMID 33912979 · DOI 10.1007/s00167-021-06571-2
3. A 2D qualitative movement assessment of a deceleration task detects football players with high knee joint loading.
   Di Paolo S, Zaffagnini S, Tosarelli F, Aggio F, et al · · 2021 · cited 18× · PMID 34480582 · DOI 10.1007/s00167-021-06709-2
4. Two-Dimensional and Three-Dimensional Biomechanical Factors During 90° Change of Direction are Associated to Non-Contact ACL injury in Female Soccer Players.
   Di Paolo S, Grassi A, Tosarelli F, Crepaldi M, et al · · 2023 · cited 12× · PMID 37547837 · DOI 10.26603/001c.84308
5. Knee Joint Contact Forces during High-Risk Dynamic Tasks: 90° Change of Direction and Deceleration Movements.
   Cassiolas G, Di Paolo S, Marchiori G, Grassi A, et al · · 2023 · cited 10× · PMID 36829673 · DOI 10.3390/bioengineering10020179
6. Beyond Distance: A Simple Qualitative Assessment of the Single-Leg Hop Test in Return-to-Play Testing.
   Di Paolo S, Zaffagnini S, Tosarelli F, Grassi A, et al · · 2022 · cited 10× · PMID 35081839 · DOI 10.1177/19417381211063450
7. Development and Validation of an Algorithm for Foot Contact Detection in High-Dynamic Sports Movements Using Inertial Measurement Units.
   Di Paolo S, Mendicino M, Palha de Araújo Dos Santos JM, Nijmeijer E, et al · · 2026 · PMID 41682504 · DOI 10.3390/s26030988