Takuma Ii

Abstract Background Gait—a frequently performed activity of daily living—is thought to reflect multiple dimensions of an individual’s physical and cognitive status. Individuals with frailty or mild cognitive impairment (MCI) show decreased gait speed. However, previous studies have not simultaneously considered both statuses, although they frequently co-occur and may act as confounders. The direct association between frailty and gait is well-understood. In contrast, the association between cognitive decline—independent of physical function—and decreased gait speed, as well as the relationship among these three factors (frailty, cognitive decline, and gait speed), is not fully understood. Methods This study examined the effect of MCI on gait speed after accounting for frailty. Older individuals were categorized as (1) frailty with MCI, (2) frailty without MCI, (3) pre-frailty with MCI, (4) pre-frailty without MCI, (5) non-frailty with MCI, and (6) non-frailty without MCI. Frailty was assessed using the Kihon checklist and MCI using the Montreal Cognitive Assessment. Participants completed a 10-m walk test under two conditions: comfortable walking and fast walking. Two types of analyses were conducted: mediation analysis and two-way analysis of covariance (ANCOVA). Results Mediation analysis supported independent relationships between frailty and MCI status and gait speed, suggesting a direct association between MCI and gait speed, even when accounting for frailty. In addition, two-way analysis of covariance indicated significant main effects of both frailty and MCI on gait speed, with no significant interaction between them under the two walking conditions. Conclusions These findings suggest that the observed association between MCI and gait speed is largely independent from frailty status, providing additional evidence supporting the association between cognitive function and gait performance.

BACKGROUND: Robot-assisted gait training (RAGT) has proven effective in addressing gait disorders in patients with stroke. However, its efficacy in patients with acute stroke has not yet been demonstrated. This pilot study is designed to evaluate the following: (1) feasibility of conducting a randomized controlled trial on RAGT for enhancing gait postacute stroke and (2) to obtain preliminary estimates regarding the potential efficacy of RAGT for achieving gait independence during the acute phase. METHODS: We will conduct an assessor-blinded, single-center, randomized controlled pilot trial involving 32 patients with acute stroke who are unable to walk. Participants will be randomly assigned to either the RAGT or the conventional gait training (CGT) groups. Each participant will receive 180 min of daily rehabilitation, including 60 min dedicated to gait training. The RAGT group will receive 40 min of RAGT and 20 min of CGT, while the CGT group will engage in 60 min of CGT. Interventions will continue for up to 8 weeks, or until participants achieve gait independence, as indicated by a Functional Ambulation Category score of ≥ 3. Feasibility outcomes will include recruitment, enrollment, protocol adherence, and retention rates. The primary clinical outcome will be the incidence of achieving gait independence during the intervention period. Secondary clinical outcomes will include gait performance measures, assessments of physical function and activity, and intervention dose. Adverse events associated with RAGT and CGT will also be documented to evaluate the safety of both interventions. DISCUSSION: Implementing RAGT during the acute phase of stroke may facilitate earlier attainment of gait independence compared to CGT. We aim to provide valuable insights into the feasibility of the proposed study design and generate preliminary data on the potential effects of RAGT on gait independence in the acute phase of stroke, providing a framework for future larger-scale trials. TRIAL REGISTRATION: This clinical trial was registered with the Japan Clinical Trials Registry (jRCT) on 19 June 2023 (registration number: jRCTs042230040). The study protocol was initially registered as version 1.0 and has since undergone minor amendments-currently on version 4.0. This protocol was written based on the latest version (ver. 4.0) registered with jRCT.