PMID- 37936135 OWN - NLM STAT- MEDLINE DCOM- 20231115 LR - 20240210 IS - 1743-0003 (Electronic) IS - 1743-0003 (Linking) VI - 20 IP - 1 DP - 2023 Nov 7 TI - Effects of high-intensity gait training with and without soft robotic exosuits in people post-stroke: a development-of-concept pilot crossover trial. PG - 148 LID - 10.1186/s12984-023-01267-9 [doi] LID - 148 AB - INTRODUCTION: High-intensity gait training is widely recognized as an effective rehabilitation approach after stroke. Soft robotic exosuits that enhance post-stroke gait mechanics have the potential to improve the rehabilitative outcomes achieved by high-intensity gait training. The objective of this development-of-concept pilot crossover study was to evaluate the outcomes achieved by high-intensity gait training with versus without soft robotic exosuits. METHODS: In this 2-arm pilot crossover study, four individuals post-stroke completed twelve visits of speed-based, high-intensity gait training: six consecutive visits of Robotic Exosuit Augmented Locomotion (REAL) gait training and six consecutive visits without the exosuit (CONTROL). The intervention arms were counterbalanced across study participants and separated by 6 + weeks of washout. Walking function was evaluated before and after each intervention using 6-minute walk test (6MWT) distance and 10-m walk test (10mWT) speed. Moreover, 10mWT speeds were evaluated before each training visit, with the time-course of change in walking speed computed for each intervention arm. For each participant, changes in each outcome were compared to minimal clinically-important difference (MCID) thresholds. Secondary analyses focused on changes in propulsion mechanics and associated biomechanical metrics. RESULTS: Large between-group effects were observed for 6MWT distance (d = 1.41) and 10mWT speed (d = 1.14). REAL gait training resulted in an average pre-post change of 68 +/- 27 m (p = 0.015) in 6MWT distance, compared to a pre-post change of 30 +/- 16 m (p = 0.035) after CONTROL gait training. Similarly, REAL training resulted in a pre-post change of 0.08 +/- 0.03 m/s (p = 0.012) in 10mWT speed, compared to a pre-post change of 0.01 +/- 06 m/s (p = 0.76) after CONTROL. For both outcomes, 3 of 4 (75%) study participants surpassed MCIDs after REAL training, whereas 1 of 4 (25%) surpassed MCIDs after CONTROL training. Across the training visits, REAL training resulted in a 1.67 faster rate of improvement in walking speed. Similar patterns of improvement were observed for the secondary gait biomechanical outcomes, with REAL training resulting in significantly improved paretic propulsion for 3 of 4 study participants (p < 0.05) compared to 1 of 4 after CONTROL. CONCLUSION: Soft robotic exosuits have the potential to enhance the rehabilitative outcomes produced by high-intensity gait training after stroke. Findings of this development-of-concept pilot crossover trial motivate continued development and study of the REAL gait training program. CI - (c) 2023. The Author(s). FAU - Porciuncula, Franchino AU - Porciuncula F AD - Department of Physical Therapy, Center for Neurorehabilitation, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. AD - Department of Physical Therapy, Neuromotor Recovery Lab, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. AD - Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA, USA. FAU - Arumukhom Revi, Dheepak AU - Arumukhom Revi D AD - Department of Physical Therapy, Neuromotor Recovery Lab, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. AD - Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA, USA. AD - Department of Mechanical Engineering, Boston University, Boston, MA, USA. FAU - Baker, Teresa C AU - Baker TC AD - Department of Physical Therapy, Center for Neurorehabilitation, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. AD - Department of Physical Therapy, Neuromotor Recovery Lab, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. FAU - Sloutsky, Regina AU - Sloutsky R AD - Department of Physical Therapy, Neuromotor Recovery Lab, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. FAU - Walsh, Conor J AU - Walsh CJ AD - Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA, USA. FAU - Ellis, Terry D AU - Ellis TD AD - Department of Physical Therapy, Center for Neurorehabilitation, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. FAU - Awad, Louis N AU - Awad LN AD - Department of Physical Therapy, Neuromotor Recovery Lab, College of Health and Rehabilitation Sciences: Sargent College, Boston University, Boston, MA, USA. louawad@bu.edu. AD - Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA, USA. louawad@bu.edu. AD - Department of Mechanical Engineering, Boston University, Boston, MA, USA. louawad@bu.edu. LA - eng GR - R01 HD088619/HD/NICHD NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't PT - Research Support, U.S. Gov't, Non-P.H.S. DEP - 20231107 PL - England TA - J Neuroeng Rehabil JT - Journal of neuroengineering and rehabilitation JID - 101232233 SB - IM MH - Humans MH - Cross-Over Studies MH - Gait MH - *Robotics MH - *Stroke/complications MH - *Stroke Rehabilitation/methods MH - Walking PMC - PMC10629136 OTO - NOTNLM OT - Exosuits OT - Gait OT - Robotics OT - Stroke COIS- Patents describing the exosuit components documented in this article have been filed with the U.S. Patent Office. They are licensed by ReWalk Robotics and C.J.W. is an inventor. CJW was a paid consultant for ReWalk Robotics at the time this research was conducted. EDAT- 2023/11/08 00:41 MHDA- 2023/11/09 06:42 PMCR- 2023/11/07 CRDT- 2023/11/08 00:00 PHST- 2023/03/14 00:00 [received] PHST- 2023/10/11 00:00 [accepted] PHST- 2023/11/09 06:42 [medline] PHST- 2023/11/08 00:41 [pubmed] PHST- 2023/11/08 00:00 [entrez] PHST- 2023/11/07 00:00 [pmc-release] AID - 10.1186/s12984-023-01267-9 [pii] AID - 1267 [pii] AID - 10.1186/s12984-023-01267-9 [doi] PST - epublish SO - J Neuroeng Rehabil. 2023 Nov 7;20(1):148. doi: 10.1186/s12984-023-01267-9.