But all this proves is that an extra 40 minutes daily walking rehab gets you better outcome. Not necessarily proving your intervention was the reason. Does anyone in stroke have two functioning neurons to rub together for a spark of intelligence?
Effects of robot-assisted gait training using the Welwalk on gait independence for individuals with hemiparetic stroke: an assessor-blinded, multicenter randomized controlled trial
Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 76 (2024)
Abstract
Background
Gait disorder remains a major challenge for individuals with stroke, affecting their quality of life and increasing the risk of secondary complications. Robot-assisted gait training (RAGT) has emerged as a promising approach for improving gait independence in individuals with stroke. This study aimed to evaluate the effect of RAGT in individuals with subacute hemiparetic stroke using a one-leg assisted gait robot called Welwalk WW-1000.
Methods
An assessor-blinded, multicenter randomized controlled trial was conducted in the convalescent rehabilitation wards of eight hospitals in Japan. Participants with first-ever hemiparetic stroke who could not walk at pre-intervention assessment were randomized to either the Welwalk group, which underwent RAGT with conventional physical therapy, or the control group, which underwent conventional physical therapy alone. Both groups received 80 min of physical therapy per day, 7 days per week, while the Welwalk group received 40 min of RAGT per day, 6 days per week, as part of their physical therapy. The primary outcome was gait independence, as assessed using the Functional Independence Measure Walk Score.
Results
A total of 91 participants were enrolled, 85 of whom completed the intervention. As a result, 91 participants, as a full analysis set, and 85, as a per-protocol set, were analyzed. The primary outcome, the cumulative incidence of gait-independent events, was not significantly different between the groups. Subgroup analysis revealed that the interaction between the intervention group and stroke type did not yield significant differences in either the full analysis or per-protocol set. However, although not statistically significant, a discernible trend toward improvement with Welwalk was observed in cases of cerebral infarction for the full analysis and per-protocol sets (HR 4.167 [95%CI 0.914–18.995], p = 0.065, HR 4.443 [95%CI 0.973–20.279], p = 0.054, respectively).
Conclusions
The combination of RAGT using Welwalk and conventional physical therapy was not significantly more effective than conventional physical therapy alone in promoting gait independence in individuals with subacute hemiparetic stroke, although a trend toward earlier gait independence was observed in individuals with cerebral infarction.
Trial registration
This study was registered with the Japan Registry of Clinical Trials (https://jrct.niph.go.jp; jRCT 042180078) on March 3, 2019.
Background
Gait disorders remain a major health challenge that affects individuals with stroke. More than 12 million individuals suffer from stroke each year [1] and approximately 30% require assistance with walking [2]. Individuals with gait impairments have a decreased quality of life and activities of daily living (ADLs) [3, 4] and a higher risk of secondary impairments due to falls [5]. Therefore, the improvement of gait disorders in individuals with stroke is an important issue, and gait training has been provided in clinical practice [6, 7].
Recently, various types of gait robots have been used to assist individuals with hemiparesis during gait training. Robot-assisted gait training (RAGT) can provide intensive, repetitive, and task-oriented training for individuals with hemiparetic stroke who have difficulty walking independently, by partially or fully supporting their body weight and movements using a robot control mechanism [8]. A systematic review showed that a higher percentage of individuals with hemiparetic stroke within 3 months of stroke onset achieved gait independence by combining RAGT with conventional training [9]. Hence, its use is currently recommended in several treatment guidelines [10].
However, most gait robots for individuals with difficulty walking have been designed to assist both legs [11, 12]. These robots assist the patient in achieving a symmetrical gait, which can be problematic when used in patients with hemiparetic stroke. If the patient has severe motor paralysis and requires compensatory movements to walk, the gait achieved will not be symmetrical. Therefore, training a symmetrical gait may have low task transferability to the target gait. Therefore, we developed a simpler, one-leg assisted gait robot, called Welwalk WW-1000 (Welwalk, Toyota Motor Corporation, Aichi, Japan) [13]. Previous studies on the effectiveness of RAGT using the Welwalk in individuals with subacute hemiparetic stroke have reported higher gait independence than conventional gait training [14, 15]. These were single-center studies with small sample sizes, and a large multicenter randomized controlled trial is needed to validate the effectiveness of RAGT using this device on gait independence. Therefore, we designed a multicenter, prospective, open-blind endpoint randomized controlled trial with blinded assessors. This study aimed to verify the effects of RAGT on gait independence in individuals with subacute hemiparetic stroke.
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