Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial

BACKGROUND: Treatment following traumatic knee injury includes neuromuscular training, with or without surgical reconstruction. The aim of rehabilitation is to restore muscle function and address psychological factors to allow a return to activity. Attention is often on rehabilitation of knee function, but deficiencies often persist. Specific interventions addressing psychological factors are sparing with varying degrees of success. We have developed a novel training program, MOTor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS), which integrates simultaneous psychological training into physical rehabilitation exercises. The MOTIFS model individualizes rehabilitation to increase central nervous system involvement by creating realistic and relevant mental images based on past experiences. We hypothesize that a 12-week MOTIFS training intervention will improve psychological readiness to return to activity and muscle function to a greater extent than current neuromuscular training (Care-as-Usual). METHODS: This pragmatic 1:1 single assessor-blinded adaptive cumulative cluster-randomized controlled trial will include 106 knee-injured people with a goal of returning to physical activity. Participants are randomized to either the MOTIFS or Care-as-Usual condition. Primary outcomes are the ACL Return to Sport after Injury Scale and change in injured leg hop performance in a side hop task from baseline to 12 weeks. Secondary outcomes include patient-reported outcomes and assessment of muscle function using a hop test battery and Postural Orientation Errors at 12-week follow-up. At 12-month follow-up, patient-reported outcomes are assessed. A sub-group (7-10 in each group) will be interviewed to gain insight into experiences of rehabilitation. DISCUSSION: Strengths of this trial include that it is a randomized and pragmatic trial examining commonly under-studied aspects of rehabilitation following a knee injury. The model uses the patient as a reference, creating simultaneous psychological and physical training exercises with easily adopted principles for clinical practice. Limitations include that blinding is limited due to study design, and shifting the clinical paradigm to a more holistic model is a challenge. If successful, the MOTIFS model has implications for a clinically useful, individualized, and patient-relevant method of improving rehabilitation outcomes by integrating psychological training into physical training. TRIAL REGISTRATION: ClinicalTrials.gov NCT03473821. Registered March 22, 2018, with ethical approval that has been granted (Dnr 2016/413, Dnr 2018/927). TRIAL STATUS: Trial Status: Protocol Version is 2020, Dec 10 – Version 1 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05713-8.