Interdisciplinary Rehabilitation for Concussion Recovery (i-RECOveR): protocol of an investigator-blinded, randomised, case series with multiple baseline design to evaluate the feasibility and preliminary efficacy of a 12-week treatment for persistent post-concussion symptoms

Abstract

Background Up to 25% of concussed individuals experience persistent post-concussion symptoms (PPCSs) which may interfere with the return to pre-injury activities and cause significant stress. Given that multiple etiological factors are thought to contribute to PPCSs, an interdisciplinary approach is recommended. This pilot study aims to primarily investigate the feasibility of a novel interdisciplinary treatment for PPCSs. Given this intervention is novel, uncertainty exists in terms of potential recruitment and retention rates, adverse events, and treatment adherence and fidelity. These factors will be explored to inform the feasibility of a phase-2 randomised controlled trial. Preliminary efficacy of this intervention will also be explored. Methods Fifteen individuals with mild traumatic brain injury and PPCSs will receive up to 12 weeks of interdisciplinary treatments including psychology, physiotherapy, and medical interventions. Primary feasibility outcomes including data on recruitment and retention rates and treatment adherence will be explored descriptively. The cognitive therapy rating scale will be used to assess treatment fidelity. A single-case series with multiple baseline design will be used to explore preliminary efficacy. Participants will be randomly assigned to baseline phases of 2, 4, or 6 weeks. Regarding patient-centred secondary outcomes, the Rivermead Post-Concussion Symptoms Questionnaire will be assessed three times a week during baseline and treatment phases. Secondary outcomes also include measures of mood, sleep and fatigue, physical functioning, return to activity, and health-related quality of life. Patient-centred outcomes will be assessed at baseline, pretreatment, post-treatment, and one- and three-month follow-up. Thematic analysis of participant experiences will be explored through qualitative interviews. Discussion Results from this trial will inform the feasibility and preliminary efficacy of this interdisciplinary concussion intervention and whether proceeding to a future definitive phase-2 randomised controlled trial is worthwhile. Understanding the end-user perspective of the treatment will also enable modifications to the treatment protocol for future trials to best suit the needs of individuals with PPCSs after mTBI. Outcomes from this trial can be directly translated into community rehabilitation programmes. Trial registration ANZCTR, ACTRN12620001111965. Registered 27 October 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379118

Benefits of a 12-Week Non-Drug “Brain Fitness Program” for Patients with Attention-Deficit/Hyperactive Disorder, Post-Concussion Syndrome, or Memory Loss

“…Many of the non-drug interventions described above have been combined into multi-disciplinary programs [29][30][31][32][33][34][35][36]. A 2-year randomized controlled trial with a multidomain lifestyle intervention showed a reduction in cognitive decline based on results of comprehensive neurological testing [37,38].…”

Maximizing the Clinical Value of Blood-Based Biomarkers for Mild Traumatic Brain Injury

“…While TBI is well known to cause cognitive, motor, and behavioral symptoms, both acutely and as long-term complications, its morbidity is difficult to quantify. Although most TBI is characterized as mild, even these less severe head injuries can bring long-term sequelae [2]. Understanding the severity of TBI and establishing proper diagnostic methods for TBI is critical for the patient's functional recovery and for structuring a personalized rehabilitation plan [1,2].…”

“…Although most TBI is characterized as mild, even these less severe head injuries can bring long-term sequelae [2]. Understanding the severity of TBI and establishing proper diagnostic methods for TBI is critical for the patient's functional recovery and for structuring a personalized rehabilitation plan [1,2]. Traumatic axonal injury (TAI) comes with high variability in type and degree of neurological impairment, with injury location a significant determinant of prognosis [3].…”