TY  - JOUR
A1  - Niederer, Daniel
A1  - Keller, Matthias
A1  - Achtnich, Andrea
A1  - Akoto, Ralph
A1  - Ateschrang, Atesch
A1  - Banzer, Winfried
A1  - Barié, Alexander
A1  - Best, Raymond
A1  - Ellermann, Andree
A1  - Fischer, Andreas
A1  - Günther, Daniel
A1  - Herbort, Mirco
A1  - Höher, Jürgen
A1  - Janko, Maren Carina
A1  - Jung, Tobias
A1  - Krause, Matthias
A1  - Petersen, Wolf
A1  - Stoffels, Thomas
A1  - Stöhr, Amelie
A1  - Welsch, Frederic
A1  - Stein, Thomas
T1  - 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)
T2  - Trials
N2  - 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.
KW  - Return to sports
KW  - Return to play
KW  - RTS
KW  - Recurrence
KW  - Re-injury
KW  - ACL
KW  - Motor control
KW  - Secondary prevention
KW  - Therapy
KW  - Rehabilitation
KW  - Post treatment
KW  - Functional outcome
Y1  - 2019
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/51272
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-512722
SN  - 1468-6694
SN  - 1745-6215
SN  - 1468-6708
N1  - 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.
VL  - 20
IS  - 1, Art. 495
SP  - 1
EP  - 10
PB  - BioMed Central
CY  - London
ER  -