AUTHOR=Palmcrantz Susanne , Wall Anneli , Vreede Katarina Skough , Lindberg Påvel , Danielsson Anna , Sunnerhagen Katharina S. , Häger Charlotte K. , Borg Jörgen 

TITLE=Impact of Intensive Gait Training With and Without Electromechanical Assistance in the Chronic Phase After Stroke–A Multi-Arm Randomized Controlled Trial With a 6 and 12 Months Follow Up

JOURNAL=Frontiers in Neuroscience

VOLUME=15

YEAR=2021

URL=https://www.frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2021.660726

DOI=10.3389/fnins.2021.660726

ISSN=1662-453X

ABSTRACT=<p><bold>Introduction:</bold> Movement related impairments and limitations in walking are common long-term after stroke. This multi-arm randomized controlled trial explored the impact of training with an electromechanically assisted gait training (EAGT) system, i.e., the Hybrid Assistive Limb<sup>®</sup> (HAL), when integrated with conventional rehabilitation focused on gait and mobility.</p><p><bold>Material and Methods:</bold> Participants, aged 18–70 years with lower extremity paresis but able to walk with manual support or supervision 1–10 years after stroke, were randomized to (A) HAL-training on a treadmill, combined with conventional rehabilitation interventions (HAL-group), or (B) conventional rehabilitation interventions only (Conventional group), 3 days/week for 6 weeks, or (C) no intervention (Control group). Participants in the Control group were interviewed weekly regarding their scheduled training. Primary outcome was endurance in walking quantified by the 6 Minute Walk Test (6MWT). A rater blinded to treatment allocation performed assessments pre- and post-intervention and at follow-ups at 6 and 12 months. Baseline assessment included the National Institute of Health Stroke Scale (NIHSS) and the Modified Ranking Scale (MRS). Secondary outcomes included the Fugl Meyer Assessment- Lower Extremity, 10 Meter Walk Test, Berg Balance Scale (BBS), Barthel Index (BI) and perceived mobility with the Stroke Impact Scale.</p><p><bold>Results:</bold> A total of 48 participants completed the intervention period. The HAL-group walked twice as far as the Conventional group during the intervention. Post-intervention, both groups exhibited improved 6 MWT results, while the Control group had declined. A significant improvement was only found in the Conventional group and when compared to the Control group (Tukey HSD <italic>p</italic> = 0.022), and not between the HAL group and Conventional group (Tukey HSD <italic>p</italic> = 0.258) or the HAL- group and the Control group (Tukey HSD <italic>p</italic> = 0.447). There was also a significant decline in the Conventional group from post-intervention to 6 months follow up (<italic>p</italic> = 0.043). The best fitting model to predict outcome included initial balance (BBS), followed by stroke severity (NIHSS), and dependence in activity and participation (BI and MRS).</p><p><bold>Conclusion:</bold> Intensive conventional gait training induced significant improvements long-term after stroke while integrating treadmill based EAGT had no additional value in this study sample. The results may support cost effective evidence-based interventions for gait training long-term after stroke and further development of EAGT.</p><p><bold>Trial registration:</bold> Published on <ext-link ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov/" xmlns:xlink="http://www.w3.org/1999/xlink">clinicaltrials.gov</ext-link> (NCT02545088) August 24, 2015.</p>