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.

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 (HAL), when integrated with conventional rehabilitation focused on gait and mobility. 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. 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 = 0.022), and not between the HAL group and Conventional group (Tukey HSD = 0.258) or the HAL- group and the Control group (Tukey HSD = 0.447). There was also a significant decline in the Conventional group from post-intervention to 6 months follow up ( = 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). 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. Published on clinicaltrials.gov (NCT02545088) August 24, 2015.