Gait pattern after electromechanically-assisted gait training with the Hybrid Assistive Limb and conventional gait training in sub-acute stroke rehabilitation-A subsample from a randomized controlled trial.

Introduction: Electromechanically-assisted gait training has been introduced in stroke rehabilitation as a means to enable gait training with a large number of reproducible and symmetrical task repetitions, i.e. steps. However, few studies have evaluated its impact on gait pattern functions. This study includes persons with no independent ambulation function at the start of a 4-week neurorehabilitation period in the sub-acute phase after stroke. The primary aim of the study was to evaluate whether the addition of electromechanically-assisted gait training to conventional training resulted in better gait pattern function than conventional training alone. The secondary aim was to identify correlations between overall gait quality and standardized clinical assessments. Participants and methods: Seventeen patients with no independent ambulation function who participated in a Prospective Randomized Open Blinded End-point study in the sub-acute phase after stroke were randomized into two groups; one group (n = 7) to undergo conventional training only (CONV group) and the other group (n = 10) to undergo conventional training with additional electromechanically-assisted gait training (HAL group). All patients were assessed with 3D gait analysis and clinical assessments after the 4-week intervention period. Overall gait quality as per the Gait Profile Score (GPS), as well as kinematic, and kinetic and other spatiotemporal metrics were collected and compared between intervention groups. Correlations between biomechanical and clinical outcomes were evaluated. Results: Both the CONV and HAL groups exhibited similar gait patterns with no significant differences between groups in any kinematic, kinetic parameters or other spatiotemporal metrics. The GPS for the paretic limb had a median (IQR) of 12.9° (7.8°) and 13.4° (4.3°) for the CONV and HAL groups, respectively (p = 0.887). Overall gait quality was correlated with independence in walking, walking speed, movement function and balance. We found no added benefit in gait pattern function from the electromechanically-assisted gait training compared to the conventional training alone. Discussion: This finding raises new questions about how to best design effective and optimal post-stroke rehabilitation programs in patients with moderate to severe gait impairments to achieve both independent walking and optimal gait pattern function, and about which patients should be in focus in further studies on the efficacy of electromechanically-assisted gait training. Clinical trial registration: The study was retrospectively registered at ClinicalTrials.gov, identifier (NCT02410915) on April 2015.

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.

Introduction: 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. Material and Methods: 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. Results: 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 p = 0.022), and not between the HAL group and Conventional group (Tukey HSD p = 0.258) or the HAL- group and the Control group (Tukey HSD p = 0.447). There was also a significant decline in the Conventional group from post-intervention to 6 months follow up (p = 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). Conclusion: 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. Trial registration: Published on clinicaltrials.gov (NCT02545088) August 24, 2015.

A randomized controlled study incorporating an electromechanical gait machine, the Hybrid Assistive Limb, in gait training of patients with severe limitations in walking in the subacute phase after stroke.

Early onset, intensive and repetitive, gait training may improve outcome after stroke but for patients with severe limitations in walking, rehabilitation is a challenge. The Hybrid Assistive Limb (HAL) is a gait machine that captures voluntary actions and support gait motions. Previous studies of HAL indicate beneficial effects on walking, but these results need to be confirmed in blinded, randomized controlled studies. This study aimed to explore effects of incorporating gait training with HAL as part of an inpatient rehabilitation program after stroke. Thirty-two subacute stroke patients with severe limitations in walking were randomized to incorporated HAL training (4 days/week for 4 weeks) or conventional gait training only. Blinded assessments were carried out at baseline, after the intervention, and at 6 months post stroke. The primary outcome was walking independence according to the Functional Ambulation Categories. Secondary outcomes were the Fugl-Meyer Assessment, 2-Minute Walk Test, Berg Balance Scale, and the Barthel Index. No significant between-group differences were found regarding any primary or secondary outcomes. At 6 months, two thirds of all patients were independent in walking. Prediction of independent walking at 6 months was not influenced by treatment group, but by age (OR 0.848, CI 0.719-0.998, p = 0.048). This study found no difference between groups for any outcomes despite the extra resources required for the HAL training, but highlights the substantial improvements in walking seen when evidence-based rehabilitation is provided to patients, with severe limitations in walking in the subacute stage after stroke. In future studies potential subgroups of patients who will benefit the most from electromechanically-assisted gait training should be explored.

Self-perceived functioning and disability after randomized conventional and electromechanically-assisted gait training in subacute stroke: A 6 months follow-up.

BACKGROUND: Few previous studies have assessed self-perceived functioning, disability and recovery after electromechanically-assisted gait training (EAGT). OBJECTIVE: To compare self-perceived functioning, disability and recovery after EAGT and after conventional gait training in the subacute stage after stroke, using the Stroke Impact Scale (SIS), and factors associated with self-perceived recovery, assessed at 6 months after stroke. METHODS: Patients were randomized into two groups performing a 4-week intervention period of incorporated EAGT using the Hybrid Assistive Limb (HAL) or conventional physiotherapy only. RESULTS: There were no significant differences in self-perceived strength, ADL, mobility, participation and percentage of recovery between intervention groups (p > 0.05). Self-perceived mobility was associated with improvements in objectively assessed walking speed/endurance and balance (R2 0.717, p = 0.002), and self-perceived recovery with self-perceived activities of daily living (ADL) ability (R2 0.34, p = 0.001). CONCLUSIONS: This study indicates that EAGT and conventional gait training in the subacute stage after stroke have no differential impact on self-perceived functioning, disability and recovery at 6 months after stroke. Further, the study highlights the importance of interventions targeting ADL and self-care independence during stroke rehabilitation to enhance self-perceived recovery and clinical aspects to be targeted to enhance perceived mobility.

An interactive distance solution for stroke rehabilitation in the home setting - A feasibility study.

BACKGROUND: In this study an interactive distance solution (called the DISKO tool) was developed to enable home-based motor training after stroke. OBJECTIVES: The overall aim was to explore the feasibility and safety of using the DISKO-tool, customized for interactive stroke rehabilitation in the home setting, in different rehabilitation phases after stroke. METHODS: Fifteen patients in three different stages in the continuum of rehabilitation after stroke participated in a home-based training program using the DISKO-tool. The program included 15 training sessions with recurrent follow-ups by the integrated application for video communication with a physiotherapist. Safety and feasibility were assessed from patients, physiotherapists, and a technician using logbooks, interviews, and a questionnaire. Qualitative content analysis and descriptive statistics were used in the analysis. RESULTS: Fourteen out of 15 patients finalized the training period with a mean of 19.5 minutes spent on training at each session. The DISKO-tool was found to be useful and safe by patients and physiotherapists. CONCLUSIONS: This study demonstrates the feasibility and safety of the DISKO-tool and provides guidance in further development and testing of interactive distance technology for home rehabilitation, to be used by health care professionals and patients in different phases of rehabilitation after stroke.

Clinical application of the Hybrid Assistive Limb (HAL) for gait training-a systematic review.

OBJECTIVE: The aim of this study was to review the literature on clinical applications of the Hybrid Assistive Limb system for gait training. METHODS: A systematic literature search was conducted using Web of Science, PubMed, CINAHL and clinicaltrials.gov and additional search was made using reference lists in identified reports. Abstracts were screened, relevant articles were reviewed and subject to quality assessment. RESULTS: Out of 37 studies, 7 studies fulfilled inclusion criteria. Six studies were single group studies and 1 was an explorative randomized controlled trial. In total, these studies involved 140 participants of whom 118 completed the interventions and 107 used HAL for gait training. Five studies concerned gait training after stroke, 1 after spinal cord injury (SCI) and 1 study after stroke, SCI or other diseases affecting walking ability. Minor and transient side effects occurred but no serious adverse events were reported in the studies. Beneficial effects on gait function variables and independence in walking were observed. CONCLUSIONS: The accumulated findings demonstrate that the HAL system is feasible when used for gait training of patients with lower extremity paresis in a professional setting. Beneficial effects on gait function and independence in walking were observed but data do not allow conclusions. Further controlled studies are recommended.