Effectiveness of a home-based re-injury prevention program on motor control, return to sport and recurrence rates after anterior cruciate ligament reconstruction : study protocol for a multicenter, single-blind, randomized controlled trial (PReP)

  • Background: Although anterior cruciate ligament (ACL) tear-prevention programs may be effective in the (secondary) prevention of a subsequent ACL injury, little is known, yet, on their effectiveness and feasibility. This study assesses the effects and implementation capacity of a secondary preventive motor-control training (the Stop-X program) after ACL reconstruction. Methods and design: A multicenter, single-blind, randomized controlled, prospective, superiority, two-arm design is adopted. Subsequent patients (18–35 years) with primary arthroscopic unilateral ACL reconstruction with autologous hamstring graft are enrolled. Postoperative guideline rehabilitation plus Classic follow-up treatment and guideline rehabilitation plus the Stop-X intervention will be compared. The onset of the Stop-X program as part of the postoperative follow-up treatment is individualized and function based. The participants must be released for the training components. The endpoint is the unrestricted return to sport (RTS) decision. Before (where applicable) reconstruction and after the clearance for the intervention (aimed at 4–8 months post surgery) until the unrestricted RTS decision (but at least until 12 months post surgery), all outcomes will be assessed once a month. Each participant is consequently measured at least five times to a maximum of 12 times. Twelve, 18 and 24 months after the surgery, follow-up-measurements and recurrence monitoring will follow. The primary outcome assessement (normalized knee-separation distance at the Drop Jump Screening Test (DJST)) is followed by the functional secondary outcomes assessements. The latter consist of quality assessments during simple (combined) balance side, balance front and single-leg hops for distance. All hop/jump tests are self-administered and filmed from the frontal view (3-m distance). All videos are transferred using safe big content transfer and subsequently (and blinded) expertly video-rated. Secondary outcomes are questionnaires on patient-reported knee function, kinesiophobia, RTS after ACL injury and training/therapy volume (frequency – intensity – type and time). All questionnaires are completed online using the participants’ pseudonym only. Group allocation is executed randomly. The training intervention (Stop-X arm) consists of self-administered home-based exercises. The exercises are step-wise graduated and follow wound healing and functional restoration criteria. The training frequency for both arms is scheduled to be three times per week, each time for a 30 min duration. The program follows current (secondary) prevention guidelines. Repeated measurements gain-score analyses using analyses of (co-)variance are performed for all outcomes. Trial registration: German Clinical Trials Register, identification number DRKS00015313. Registered on 1 October 2018.

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Author:Daniel NiedererORCiDGND, Matthias Keller, Andrea Achtnich, Ralph Akoto, Atesch Ateschrang, Winfried BanzerGND, Alexander Barié, Raymond Best, Andree Ellermann, Andreas Fischer, Daniel Günther, Mirco Herbort, Jürgen Höher, Maren Carina JankoORCiDGND, Tobias Jung, Matthias Krause, Wolf Petersen, Thomas Stoffels, Amelie Stöhr, Frederic Welsch, Thomas Stein
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/31409425
Parent Title (English):Trials
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Year of Completion:2019
Date of first Publication:2019/08/13
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2019/10/07
Tag:ACL; Functional outcome; Motor control; Post treatment; RTS; Re-injury; Recurrence; Rehabilitation; Return to play; Return to sports; Secondary prevention; Therapy
Issue:1, Art. 495
Page Number:10
First Page:1
Last Page:10
Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Institutes:Psychologie und Sportwissenschaften / Sportwissenschaften
Medizin / Medizin
Wissenschaftliche Zentren und koordinierte Programme / Starker Start ins Studium: Qualitätspakt Lehre
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
7 Künste und Unterhaltung / 79 Sport, Spiele, Unterhaltung / 790 Freizeitgestaltung, darstellende Künste, Sport
Open-Access-Publikationsfonds:Psychologie und Sportwissenschaften
Licence (German):License LogoCreative Commons - Namensnennung 4.0