METHODS AND ANALYSIS: This study is an international, multicentre, randomised controlled study at five institutions with a total of 150 patients with subacute stroke. Participants will be randomised into two groups (75 patients in the robot-assisted gait training (RAGT) group and 75 patients in the control group). The gait training will be performed with a total of 20 sessions (60 min/session); 5 sessions a week for 4 weeks. The RAGT group will receive 30 min of gait training using an exoskeleton (ANGEL LEGS M20, Angel Robotics) and 30 min of conventional gait training, while the control group will receive 60 min conventional gait training. In all the patients, the functional assessments such as ambulation, motor and balance will be evaluated before and after the intervention. Follow-up monitoring will be performed to verify whether the patient can walk without physical assistance for 3 months. The primary outcome is the improvement of the Functional Ambulatory Category after the gait training. The functional assessments will also be evaluated immediately after the last training session in the RAGT group to assess the assistive effects of an exoskeletal wearable robot. This trial will provide evidence on the effects of an exoskeleton to improve and assist ambulatory function in patients with subacute stroke.
ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board of each hospital and conforms to the Declaration of Helsinki. The results will be disseminated through publication.
TRIAL REGISTRATION NUMBER: Protocol was registered at ClinicalTrials.gov (NCT05157347) on 15 December 2021 and CRIS (KCT0006815) on 19 November 2021.
OBJECTIVE: The objective of the study is to identify the factors that have had a significant impact on mobility in recent years and currently, and to identify gaps in our understanding of these factors. The study aims to highlight areas where further research is needed and where new and effective solutions are required.
METHODS: The PRISMA methodology was used to conduct a scoping review in the Scopus and Web of Science databases. Papers published from 2007 to 2021 were searched in November 2021. Of these, 52 papers were selected from the initial 788 outputs for the final analysis.
RESULTS: The final selected papers were analyzed, and the key determinants were found to be environmental, physical, cognitive, and psychosocial, which confirms the findings of previous studies. One new determinant is technological. New and effective solutions lie in understanding the interactions between different determinants of mobility, addressing environmental factors, and exploring opportunities in the context of emerging technologies, such as the integration of smart home technologies, design of accessible and age-friendly public spaces, development of policies and regulations, and exploration of innovative financing models to support the integration of assistive technologies into the lives of seniors.
CONCLUSION: For an effective and comprehensive solution to support senior mobility, the determinants cannot be solved separately. Physical, cognitive, psychosocial, and technological determinants can often be perceived as the cause/motivation for mobility. Further research on these determinants can help to arrive at solutions for environmental determinants, which, in turn, will help improve mobility. Future studies should investigate financial aspects, especially since many technological solutions are expensive and not commonly available, which limits their use.
AIM: To define optimal early mobility intervention regimens for ischemic stroke patients of mild and moderate severity.
HYPOTHESES: Compared with a prespecified reference arm, the optimal dose regimen(s) will result in more participants experiencing little or no disability (mRS 0-2) at 3 months post-stroke (primary), fewer deaths at 3 months, fewer and less severe complications during the intervention period, faster recovery of unassisted walking, and better quality of life at 3 months (secondary). We also hypothesize that these regimens will be more cost-effective.
SAMPLE SIZE ESTIMATES: For the primary outcome, recruitment of 1300 mild and 1400 moderate participants will yield 80% power to detect a 10% risk difference.
METHODS AND DESIGN: Multi-arm multi-stage covariate-adjusted response-adaptive randomized trial of mobility training commenced within 48 h of stroke in mild (NIHSS 2) and hemorrhagic stroke. With four arms per stratum (reference arm retained throughout), only the single treatment arm demonstrating the highest proportion of favorable outcomes at the first stage will proceed to the second stage in each stratum, resulting in a final comparison with the reference arm. Three prognostic covariates of age, geographic region and reperfusion interventions, as well as previously observed mRS 0-2 responses inform the adaptive randomization procedure. Participants randomized receive prespecified mobility training regimens (functional task-specific), provided by physiotherapists/nurses until discharge or 14 days. Interventions replace usual mobility training. Fifty hospitals in seven countries (Australia, Malaysia, United Kingdom, Ireland, India, Brazil, Singapore) are expected to participate.
SUMMARY: Our novel adaptive trial design will evaluate a wider variety of mobility regimes than a traditional two-arm design. The data-driven adaptions during the trial will enable a more efficient evaluation to determine the optimal early mobility intervention for patients with mild and moderate ischemic stroke.
METHODS: A quasi-experimental study was conducted involving 109 elderly people with a body mass index (BMI) ≥25.0 kg/m2. BMI, body composition, and average daily steps were measured at baseline, 6 weeks, and 12 weeks. Data were analyzed using SPSS version 26.0, and repeated-measures analysis of variance with the paired t-test for post-hoc analysis was conducted.
RESULTS: In total, 48 participants in the intervention group and 61 participants in the control group completed the study. A significant interaction was found between time and group. The post-hoc analysis showed a significant difference between pre-intervention and post-intervention (within the intervention group). The post-intervention analysis revealed an increase in the mean number of daily steps by 3571.59, with decreases in body weight (-2.20 kg), BMI (-0.94 kg/m2), body fat percentage (-3.52%), visceral fat percentage (-1.29%) and waist circumference (-2.91 cm). Skeletal muscle percentage also showed a significant increase (1.67%).
CONCLUSIONS: A 12-week walking program combining a 7000-step goals with weekly group walking activities had a significant effect on the anthropometric measurements of previously inactive and overweight/obese elderly people.