Abstract
Introduction Tetraplegia causes extensive sensorimotor deficits affecting activity, participation and quality of life. People with C6-C7 tetraplegia can learn to grasp objects by performing wrist extension movement (ie, tenodesis grasp), and motor imagery (MI) added to rehabilitation significantly improved tenodesis grasp. We hypothesise that this improvement can be further boosted by adding neurofeedback during MI. Thus, we design a randomised controlled trial investigating the effect of MI training on grasping ability in people with C6-C7 tetraplegia. Methods and analysis We will perform a bicentric, assessor-blinded, randomised controlled study. During rehabilitation, 21 inpatients with C6-C7 tetraplegia will be allocated to MI with neurofeedback (MI training with graphical display on a computer screen based on mu (8–13 Hz) and beta (18–25 Hz) frequency rhythms measured with 32-channel electroencephalography), MI alone (only MI training) and control (watching movies and visualisation of geometric shapes). All participants will receive three 45-min training sessions per week for 5 weeks. The primary outcome measure will be wrist extension angle immediately after the intervention during tenodesis grasp measured with a 3D motion analysis system (VICON). Secondary outcomes will include a range of measures: kinematic, grip strength, upper limb range of motion, upper limb strength (manual muscle test and hand-held dynamometer measure), dexterity (box and block test, 9-hole peg test, Jebsen test, capabilities of upper extremity questionnaire), quality of life (WHOQOL-Bref), daily life autonomy (Quadriplegic Index of Function), MI capacity and brain reorganisation (magnetoencephalography only available in Lyon, n=15). We will measure all outcomes five times: during weeks 1, 3 and 5 (baseline), week 11 (immediately after the intervention end) and week 18 (8 weeks after the intervention end). Ethics and dissemination Ethical approval was granted on 29 September 2017 (CPP Nord-Ouest-IV 17/25, N°2017-A00990-53). Dissemination will occur via presentation of results in scientific meetings and publication in peer-reviewed academic journals. Trial registration number NCT03190863 (ClinicalTrials.gov).