Palmcrantz Susanne, Wall Anneli, Vreede Katarina Skough, Lindberg Påvel, Danielsson Anna, Sunnerhagen Katharina S, Häger Charlotte K, Borg Jörgen
Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
Institut de Psychiatrie et Neurosciences de Paris, Inserm U1266, Université de Paris, Paris, France.
Front Neurosci. 2021 Apr 22;15:660726. doi: 10.3389/fnins.2021.660726. eCollection 2021.
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.
中风后长期存在与运动相关的行走障碍和限制。这项多臂随机对照试验探讨了机电辅助步态训练（EAGT）系统，即混合辅助肢体（HAL）与专注于步态和活动能力的传统康复相结合时的训练效果。年龄在18 - 70岁之间、下肢轻瘫但中风后1 - 10年在人工支持或监督下能够行走的参与者被随机分为：（A）在跑步机上进行HAL训练并结合传统康复干预（HAL组），或（B）仅进行传统康复干预（传统组），每周3天，共6周，或（C）不进行干预（对照组）。对照组参与者每周接受关于其预定训练的访谈。主要结局是通过6分钟步行试验（6MWT）量化的行走耐力。一名对治疗分配不知情的评估者在干预前后以及6个月和12个月的随访时进行评估。基线评估包括美国国立卫生研究院卒中量表（NIHSS）和改良Rankin量表（MRS）。次要结局包括Fugl Meyer下肢评估、10米步行试验、伯格平衡量表（BBS）、Barthel指数（BI）以及卒中影响量表所感知的活动能力。共有48名参与者完成了干预期。干预期间，HAL组行走的距离是传统组的两倍。干预后，两组的6MWT结果均有所改善，而对照组则有所下降。仅在传统组与对照组相比时发现有显著改善（Tukey HSD = 0.022），而HAL组与传统组（Tukey HSD = 0.258）或HAL组与对照组（Tukey HSD = 0.447）之间未发现显著差异。从干预后到6个月随访，传统组也有显著下降（ = 0.043）。预测结局的最佳拟合模型包括初始平衡（BBS），其次是卒中严重程度（NIHSS）以及活动和参与的依赖程度（BI和MRS）。强化传统步态训练在中风后长期可带来显著改善，而在本研究样本中，结合基于跑步机的EAGT并无额外价值。这些结果可能支持中风后长期步态训练的具有成本效益的循证干预措施以及EAGT的进一步发展。于2015年8月24日发表在clinicaltrials.gov（NCT02545088）上。
