Abstract
BACKGROUND: If adults practice several motor tasks together, random practice leads to better transfer and retention compared to blocked practice. Knowledge about this contextual interference (CI) effect could be valuable to improve neurorehabilitation of children. We present the protocol of a randomised controlled pilot study investigating the feasibility of blocked practice vs. random practice of robot-assisted upper limb reaching in children with brain lesions undergoing neurorehabilitation. METHODS: Children with affected upper limb function due to congenital or acquired brain lesions undergoing neurorehabilitation will be recruited for a randomised controlled pilot study with a 3-week procedure. In the control week (1), two assessment blocks (robot-assisted reaching tasks, Melbourne assessment 2, subscale fluency), 2 days apart, take place. In the practice week (2), participants are randomly allocated to blocked practice or random practice and perform 480 reaching and backward movements in the horizontal and vertical plane using exergaming with an exoskeleton robot per day during three consecutive days. Assessments are performed before, directly after and 1 day after the practice sessions. In the follow-up week (3), participants perform the assessments 1 week after the final practice session. The primary outcome is the immediate transfer of the Melbourne Assessment 2, subscale fluency. Secondary outcomes are the immediate retention, 1-day and 1-week delayed transfer and retention and acquisition during the practice sessions. We will evaluate the feasibility of the inclusion criteria, the recruitment rate, the scheduling procedure, the randomisation procedure, the procedure for the participants, the handling of the robot, the handling of the amount of data, the choice of the outcome measures and the influence of other therapies. Furthermore, we will perform a power calculation using the data to estimate the sample size for the main trial. DISCUSSION: The protocol of the pilot study is a first step towards a future main randomised controlled trial. This low risk pilot study might induce some benefits for the participants. However, we need to place its results into perspective, especially concerning the generalisability, as it remains questionable whether improving reaching constrained within a robotic device will ameliorate daily life reaching tasks. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02443857.