Investigating the role of therapist-patient interaction during robot-assisted gait training after incomplete spinal cord injury: the INTER-RO-GAIT randomized controlled trial

Abstract Background In the neurorehabilitation framework of treadmill-based robot-assisted gait training (t-RAGT), a threefold relationship among physiotherapist (Pht), patient (Pt), and the selected robotic device should be considered. Furthermore, the type of visual FeedBack (FB) selected for the training and how the Pht guides and supports the Pt have an important impact on Pt’s engagement. Pht-Pt interaction is mostly effective when FB with high technical content is employed, and it affects Pt’s visual attention and emotional experience during training. The INTER-RO-GAIT project proposes an experimental modulation of Pht-Pt interaction during the training with the Lokomat device, to primarily investigate its role in the effectiveness of t-RAGT for individuals with subacute and chronic incomplete spinal cord injury (i-SCI) through a longitudinal randomized controlled trial (RCT), by means of clinical scales and biomechanical data. Timed walking tests for gait speed evaluation (10-Meter Walking Test and 6-Minute Walking Test) are considered as primary outcome measures, while clinical scales for the assessment of lower limbs’ force, spasticity, pain, clonus, spasms, and independence in activities of daily living are selected as secondary outcome measures. The biomechanical assessment includes overground gait analysis to assess recovery of motor functions, and human-Lokomat interaction analysis to measure the active Pt participation in the exercise and evaluate its evolution along training. Secondary aims are as follows: (i) to identify neurophysiological indices derived from electroencephalography (EEG) hyperscanning data monitoring the Pht-Pt relationship along t-RAGT; (ii) to evaluate the Pt’s engagement in terms of Visual Attention during the RAGT; (iii) to investigate the correlation between the rehabilitation outcome and the neurophysiological indices or the psychological metrics referring to Pht-Pt relationship. Methods Fifty participants from I.R.C.C.S. Fondazione Santa Lucia (Rome, Italy) will be enrolled and randomized into a single-blind RCT to investigate the effects of 12 Lokomat t-RAGT sessions administered with two different levels of Pht-Pt interaction (high level of interaction for the experimental (EXP) group and low level of interaction for the control (CTRL) group), as an add-on training to conventional rehabilitation. Before and after the whole t-RAGT, as well as at the first, the mid, and the last training session, a battery of clinical, biomechanical, psychological, and neurophysiological assessments will be conducted. Discussion Given that incomplete subacute or chronic SCI may lead to long-term disability for which cost-effective rehabilitation options are critically needed, INTER-RO-GAIT aims at providing evidence for an optimal Pht-Pt interaction to potentially boost the t-RAGT effects on Pts’ performance, improving robotic rehabilitation protocols and devices development even beyond the specific gait application. Trial registration Patient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury (INTER-RO-GAIT); ClinicalTrial.gov platform registration number: GR-2019–12369207 on 31st July 2024.