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)

Trials, 2019 · DOI: https://doi.org/10.1186/s13063-019-3610-2 · Published: September 26, 2019

Orthopedics Rehabilitation Public Health

Simple Explanation

This study aims to determine if a home-based exercise program (Stop-X) can help athletes return to sports safely after ACL reconstruction. The program focuses on improving motor control and preventing re-injury. Participants will be randomly assigned to either a standard rehabilitation program or the standard program plus the Stop-X intervention. Researchers will track their progress, including motor control, knee function, and re-injury rates. The findings will help determine if the Stop-X program is more effective than standard rehabilitation in preventing re-injuries and facilitating a safe return to sports after ACL reconstruction.

Study Duration

At least 12 months post surgery

Participants

250 patients (18–35 years) with primary arthroscopic unilateral ACL reconstruction with autologous hamstring graft

Evidence Level

Randomized Controlled Trial

Key Findings

1
The study will assess the effects of the Stop-X program on re-injury-related motor-control/function, re-injury rates, and time to successful return to sport (RTS) after ACL reconstruction.
2
The primary outcome is the normalized knee-separation distance during a standardized Drop Jump Screening Test (DJST).
3
Secondary outcomes include quality assessments during balance and hop tests, questionnaires on knee function, kinesiophobia, RTS after ACL injury, and training volume.

Research Summary

This multicenter, single-blind, randomized controlled trial will investigate the effectiveness and feasibility of a secondary preventive motor-control training program (Stop-X) after ACL reconstruction. The study compares guideline rehabilitation plus Classic follow-up treatment versus guideline rehabilitation plus the Stop-X intervention in patients aged 18–35 years. The primary outcome is the normalized knee-separation distance at the Drop Jump Screening Test (DJST), with secondary outcomes including functional assessments, questionnaires, and recurrence monitoring.

Practical Implications

Improved Rehabilitation Protocols

If proven effective, the Stop-X program could be integrated into standard rehabilitation protocols to improve patient outcomes and reduce re-injury rates.

Pre-operative Training

The study explores the potential of the Stop-X program in pre-operative training, highlighting the importance of pre-habilitation strategies.

Wider Applicability

The results will be relevant for researchers, policymakers, and patients, contributing to the development of evidence-based strategies for secondary prevention after ACL reconstruction.

Study Limitations

1
The heterogeneity of the participants may become a limitation for the results’ interpretation.
2
The limited possibility of blinding the patients is a common limitation in clinical exercise trials.
3
The study acknowledges the challenges of applying findings broadly due to participant variability and the inherent difficulties in blinding patients in exercise trials.

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