BackgroundTo describe the design of the study aiming to examine intensive targeted cognitive rehabilitation of attention in the acute (<4 months) and subacute rehabilitation phases (4–12 months) after acquired brain injury and to evaluate the effects on function, activity and participation (return to work).Methods/DesignWithin a prospective, randomised, controlled study 120 consecutive patients with stroke or traumatic brain injury were randomised to 20 hours of intensive attention training by Attention Process Training or by standard, activity based training. Progress was evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels. Return to work was also evaluated in the post-acute phase. Primary endpoints were the changes in the attention measure, Paced Auditory Serial Addition Test and changes in work ability. Secondary endpoints included measurement of cognitive functions, activity and work return. There were 3, 6 and 12-month follow ups focussing on health economics.DiscussionThe study will provide information on rehabilitation of attention in the early phases after ABI; effects on function, activity and return to work. Further, the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation. The study was registered at ClinicalTrials.gov Protocol.Trial registrationNCT02091453, registered: 19 March 2014.

Results indicate the need for a closer connection between selection criteria and study aims. Strict inclusion and exclusion criteria render the study population less representative and, thus, reduces generalizability. Data collection is prolonged. This study, instead, advocates the use of broad inclusion criteria and common data elements and the need to report data from the total patient population. Increased awareness of the participants' socioeconomic backgrounds is also needed when recruiting to research studies.

LAY ABSTRACTOne of the most common and lasting cognitive symptoms after ABI is attention dysfunction. Although there are interventions that can improve attention, the intervention recommendations are based on studies in the chronic phase after the injury. However, most improvement occurs naturally in the early phase. The cognitive recovery process early after a brain injury is complex and rich in individual variation. Therefore, when evaluating intervention effects early on, one must consider both improvements due to treatment and individual variations in performance. This study compares two attention training interventions provided during the first four months after injury; Attention Process Training and activity-based attention training. In order to capture both improvement and individual variability, we applied process analysis using the method of statistical process control. The study identified three different trajectories for recovery: improvement at a steady or a rapid pace and no identified improvement. Both interventions led to improvement, as expected in this early stage. However, for the Attention Process Training group, performance became more stable and more predictable. The Attention Process Training method resulted in improved attention for significantly more patients and decreased day-to day variations. Differences in treatment effects were maintained at 6-month follow-up. These results emphasize the clinical benefit of the Attention Process Training method over the activity-based attention training.Background: Evaluation of outcome after intensive cognitive rehabilitation early after brain injury is complicated due to the ongoing biological recovery process. Objective: To evaluate the efficacy of Attention Process Training early after acquired brain injury through time-series measurement with statistical process control. Design: Randomized controlled trial. Method: Patients with acquired brain injury (n = 59) within 4 months' post-injury in interdisciplinary rehabilitation received an additional 20 h of attention training with Attention Process Training or with activity-based attention training. The primary outcome variable was Paced Auditory Serial Attention Test (PASAT) evaluated using statistical process control.Results: Both groups improved (p < 0.001), although a higher number of patients improved with attention process training (χ 2 (1, n = 59) = 5.93, p = 0.015) and the variability was significantly decreased. The Attention Process Training group maintained or improved performance at 6 months follow-up (χ 2 (1, n = 51) = 6,847, p = 0.033). Attention Process Training required fewer intervention hours for improvement. Based on individual performance, 3 improvement trajectories were identified: stationary, steady, and rapid improvers. Conclusion:The results indicate that attention training is promising early after acquired brain injury and that Attention Process Training boosts functional improvement. Notably, in the present group of relatively homogeneous patients, 3 different trajectories w...

Statistical process control methodology is feasible for use in early cognitive rehabilitation, since it provides information about change in a process, thus enabling adjustment of the individual treatment response. Together with the results indicating discernible subgroups that respond differently to rehabilitation, statistical process control could be a valid tool in clinical decision-making. This study is a starting-point in understanding the rehabilitation process using a real-time-measurements approach.