Robot-assisted gait training after severe traumatic brain injury for walking ability and social participation: protocol for a feasibility study.

Abstract

Traumatic brain injury (TBI) is a traumatic head injury that can lead to gait-related disabilities, and exoskeleton training may be beneficial for the recovery of this function in these patients. The objective of this study is to determine the predictions for a clinical trial, through recruitment, evaluation and intervention of gait training with Lokomat in patients after severe TBI, involving the improvement of gait speed and their social participation, intrinsically linked to their quality of life. This is a prospective, single-group, feasibility study with pre-testing and post-testing, and the intervention will be carried out three times a week for 5 weeks, with a reassessment at the ninth week, where participants will perform gait training on the Lokomat for 30 min in each session. For this study, a sample of 12 participants was sought. The outcomes will be recruitment rates, adherence, efficacy, acceptability and safety of the protocol, and it will be assessed whether the clinical outcome measures corroborate what is intended to be studied, the latter being collected in weeks 0, 5 and 9 of the protocol and the results related to feasibility will be obtained during the duration of the study, being reported as percentage, mean and SD. Possible changes to the protocol will be communicated through a note in the publication, written information to the participants and regulations to the ethics board.