J F Alingh1,2, B M Fleerkotte3,4, A C H Geurts5,6, J H Buurke3,7, B E Groen5,6, J S Rietman3,4,8, V Weerdesteyn5,6, E H F van Asseldonk8. 1. Sint Maartenskliniek Research, PO Box 9011, 6500 GM, Nijmegen, The Netherlands. j.alingh@maartenskliniek.nl. 2. Donders Institute for Brain, Cognition and Behaviour, Department of Rehabilitation, Radboud University Medical Center, Nijmegen, The Netherlands. j.alingh@maartenskliniek.nl. 3. Roessingh Research and Development, Enschede, The Netherlands. 4. Roessingh Center for Rehabilitation, Enschede, The Netherlands. 5. Sint Maartenskliniek Research, PO Box 9011, 6500 GM, Nijmegen, The Netherlands. 6. Donders Institute for Brain, Cognition and Behaviour, Department of Rehabilitation, Radboud University Medical Center, Nijmegen, The Netherlands. 7. Department of Biomedical Signals and Systems, University of Twente, Enschede, The Netherlands. 8. Department of Biomechanical Engineering, University of Twente, Enschede, The Netherlands.
Abstract
BACKGROUND: Regaining gait capacity is an important rehabilitation goal post stroke. Compared to clinically available robotic gait trainers, robots with an assist-as-needed approach and multiple degrees of freedom (AANmDOF) are expected to support motor learning, and might improve the post-stroke gait pattern. However, their benefits compared to conventional gait training have not yet been shown in a randomized controlled trial (RCT). The aim of this two-center, assessor-blinded, RCT was to compare the effect of AANmDOF robotic to conventional training on the gait pattern and functional gait tasks during post-stroke inpatient rehabilitation. METHODS:Thirty-four participants with unilateral, supratentorial stroke were enrolled (< 10 weeks post onset, Functional Ambulation Categories 3-5) and randomly assigned to six weeks of AANmDOF robotic (combination of training in LOPES-II and conventional gait training) or conventional gait training (30 min, 3-5 times a week), focused on pre-defined training goals. Randomization and allocation to training group were carried out by an independent researcher. External mechanical work (WEXT), spatiotemporal gait parameters, gait kinematics related to pre-defined training goals, and functional gait tasks were assessed before training (T0), after training (T1), and at 4-months follow-up (T2). RESULTS:Two participants, one in each group, were excluded from analysis because of discontinued participation after T0, leaving 32 participants (AANmDOF robotic n = 17; conventional n = 15) for intention-to-treat analysis. In both groups, WEXT had decreased at T1 and had become similar to baseline at T2, while gait speed had increased at both assessments. In both groups, most spatiotemporal gait parameters and functional gait tasks had improved at T1 and T2. Except for step width (T0-T1) and paretic step length (T0-T2), there were no significant group differences at T1 or T2 compared to T0. In participants with a pre-defined goal aimed at foot clearance, paretic knee flexion improved more in the AANmDOF robotic group compared to the conventional group (T0-T2). CONCLUSIONS: Generally, AANmDOF robotic training was not superior to conventional training for improving gait pattern in subacute stroke survivors. Both groups improved their mechanical gait efficiency. Yet, AANmDOF robotic training might be more effective to improve specific post-stroke gait abnormalities such as reduced knee flexion during swing. Trial registration Registry number Netherlands Trial Register ( www.trialregister.nl ): NTR5060. Registered 13 February 2015.
RCT Entities:
BACKGROUND: Regaining gait capacity is an important rehabilitation goal post stroke. Compared to clinically available robotic gait trainers, robots with an assist-as-needed approach and multiple degrees of freedom (AANmDOF) are expected to support motor learning, and might improve the post-stroke gait pattern. However, their benefits compared to conventional gait training have not yet been shown in a randomized controlled trial (RCT). The aim of this two-center, assessor-blinded, RCT was to compare the effect of AANmDOF robotic to conventional training on the gait pattern and functional gait tasks during post-stroke inpatient rehabilitation. METHODS: Thirty-four participants with unilateral, supratentorial stroke were enrolled (< 10 weeks post onset, Functional Ambulation Categories 3-5) and randomly assigned to six weeks of AANmDOF robotic (combination of training in LOPES-II and conventional gait training) or conventional gait training (30 min, 3-5 times a week), focused on pre-defined training goals. Randomization and allocation to training group were carried out by an independent researcher. External mechanical work (WEXT), spatiotemporal gait parameters, gait kinematics related to pre-defined training goals, and functional gait tasks were assessed before training (T0), after training (T1), and at 4-months follow-up (T2). RESULTS: Two participants, one in each group, were excluded from analysis because of discontinued participation after T0, leaving 32 participants (AANmDOF robotic n = 17; conventional n = 15) for intention-to-treat analysis. In both groups, WEXT had decreased at T1 and had become similar to baseline at T2, while gait speed had increased at both assessments. In both groups, most spatiotemporal gait parameters and functional gait tasks had improved at T1 and T2. Except for step width (T0-T1) and paretic step length (T0-T2), there were no significant group differences at T1 or T2 compared to T0. In participants with a pre-defined goal aimed at foot clearance, paretic knee flexion improved more in the AANmDOF robotic group compared to the conventional group (T0-T2). CONCLUSIONS: Generally, AANmDOF robotic training was not superior to conventional training for improving gait pattern in subacute stroke survivors. Both groups improved their mechanical gait efficiency. Yet, AANmDOF robotic training might be more effective to improve specific post-stroke gait abnormalities such as reduced knee flexion during swing. Trial registration Registry number Netherlands Trial Register ( www.trialregister.nl ): NTR5060. Registered 13 February 2015.
Authors: Alexander Duschau-Wicke; Joachim von Zitzewitz; Andrea Caprez; Lars Lunenburger; Robert Riener Journal: IEEE Trans Neural Syst Rehabil Eng Date: 2010-02 Impact factor: 3.802