ABSTRACT
BACKGROUND: Gait disorders and cognitive impairments are prime causes of disability and institutionalization after stroke. We hypothesized that relative to single-task gait rehabilitation (ST GR), cognitive-motor dual-task (DT) GR initiated at the subacute stage would be associated with greater improvements in ST and DT gait, balance, and cognitive performance, personal autonomy, disability, and quality of life in the short, medium and long terms after stroke. METHODS: This multicenter (n=12), two-arm, parallel-group, randomized (1:1), controlled clinical study is a superiority trial. With p<0.05, a power of 80%, and an expected loss to follow-up rate of 10%, the inclusion of 300 patients will be required to evidence a 0.1-m.s-1 gain in gait speed. Trial will include adult patients (18-90 years) in the subacute phase (0 to 6 months after a hemispheric stroke) and who are able to walk for 10 m (with or without a technical aid). Registered physiotherapists will deliver a standardized GR program (30 min three times a week, for 4 weeks). The GR program will comprise various DTs (phasic, executive function, praxis, memory, and spatial cognition tasks during gait) in the DT (experimental) group and gait exercises only in the ST (control) group. The primary outcome measure is gait speed 6 months after inclusion. The secondary outcomes are post-stroke impairments (National Institutes of Health Stroke Scale and the motor part of the Fugl-Meyer Assessment of the lower extremity), gait speed (10-m walking test), mobility and dynamic balance (timed up-and-go test), ST and DT cognitive function (the French adaptation of the harmonization standards neuropsychological battery, and eight cognitive-motor DTs), personal autonomy (functional independence measure), restrictions in participation (structured interview and the modified Rankin score), and health-related quality of life (on a visual analog scale). These variables will be assessed immediately after the end of the protocol (probing the short-term effect), 1 month thereafter (the medium-term effect), and 5 months thereafter (the long-term effect). DISCUSSION: The main study limitation is the open design. The trial will focus on a new GR program applicable at various stages after stroke and during neurological disease. TRIAL REGISTRATION: NCT03009773 . Registered on January 4, 2017.
Subject(s)
Stroke Rehabilitation , Stroke , Adult , Humans , Stroke Rehabilitation/methods , Quality of Life , Gait , Walking , Exercise Therapy/methods , Cognition , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
Gait disorders are one of the leading patient complaints at the sub-acute stroke stage (SSS) and a main determinant of disability. Walking speed (WS) is a major vital and functional index, and the Ten-Meter Walk Test is considered the gold standard after stroke. Based on a systematic review of the literature, studies published between January 2000 and November 2021 were selected when WS was reported (ten-meter walk test for short distance and/or 6-min walking distance for long distance) within 6 months following a first ischemic and/or hemorrhagic stroke (SSS) in adults prior to receiving specific walking rehabilitation. Following PRISMA guidelines, a meta-analysis was conducted on two kinds of WS: the principal criterion focused on short-distance WS (ten-meter walking test) and the secondary criteria focused on long-distance WS (6-min test) and meta-regressions to study the association of WS with balance, cognitive disorders and autonomy. Nine studies comprising a total of 939 data on post-stroke patients were selected. The weighted average age was 61 years [95% IC [55-67] and males represented 62% ± 2.7 of patients [57-67]. Average short-distance WS was 0.36 ± 0.06 m.s-1 [95% CI (0.23-0.49)]. Average long-distance WS was 0.46 ± 0.1 m.s-1 [95% CI (0.26-0.66)]. The funnel plot revealed asymmetry of publication bias and high heterogeneity of the nine studies (I 2 index 98.7% and Q-test p < 0.0001). Meta-regressions of secondary endpoints could not be performed due to a lack of study data. At the SSS, WS would be lower than data in general population published in literature, but above all, lower than the WS required for safe daily autonomy and community ambulation after stroke. WS must be a priority objective of stroke rehabilitation to increase walking function but also for survival, autonomy, social participation and health-related quality of life.
ABSTRACT
BACKGROUND AND PURPOSE: The aim of this study was to determine the contributions of background disorders responsible for participation restriction as indexed by a structured interview for the modified Rankin Scale (mRS-SI). METHODS: A subset of 256 patients was assessed at 6 months after stroke using the National Institutes of Health Stroke Scale (NIHSS), gait score, comprehensive cognitive battery (yielding a global cognitive Z-score), behavioral dysexecutive disorders (DDs), anxiety and depressive symptoms, epilepsy, and headache. Following bivariate analyses, determinants of participation restriction were selected using ordinal regression analysis with partial odds. RESULTS: Poststroke participation restriction (mRS-SI score > 1) was observed in 59% of the patients. In bivariate analyses, mRS-SI score was associated with prestroke mRS-SI score, 6-month NIHSS score, gait score, global cognitive Z-score, behavioral DDs, and presence of anxiety and depression (all: p = 0.0001; epilepsy: p =0.3; headache: p = 0.7). After logistic regression analysis, NIHSS score was associated with increasing mRS-SI score (p = 0.00001). Prestroke mRS-SI score (p = 0.00001), behavioral DDs (p = 0.0008) and global cognitive Z-score (p = 0.01) were associated with both mRS-SI score > 1 and mRS-SI score > 2. In addition, gait score was associated with mRS-SI score > 2 (p = 0.00001). This model classified 85% of mRS-SI scores correctly (p = 0.001). Structural equation modeling showed the contributions of gait limitation (standardized coefficient [SC]: 0.68; p = 0.01), prestroke mRS-SI (SC: 0.41; p = 0.01), severity of neurological impairment (SC: 0.16; p = 0.01), global cognitive Z-score (SC: -0.14; p = 0.05), and behavioral DDs (SC: 0.13; p = 0.01). CONCLUSION: These results provide a statistical model of weights of determinants responsible for poststroke participation restriction and highlight a new independent determinant: behavioral DDs.
