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Walking-adaptability therapy after stroke: results of a randomized controlled trial.

ABSTRACT: BACKGROUND:The ability to adapt walking to environmental properties and hazards, a prerequisite for safe ambulation, is often impaired in persons after stroke. RESEARCH QUESTION:The aim of this study was to compare the efficacy of two walking-adaptability interventions: a novel treadmill-based C-Mill therapy (using gait-dependent augmented reality) and the standard overground FALLS program (using physical context). We expected sustained improvements for both treatment groups combined but hypothesized better outcomes for C-Mill therapy than the FALLS program due to its expected greater amount of walking practice. METHODS:In this pre-registered single-centre parallel group randomized controlled trial, forty persons after stroke (≥ 3 months ago) with walking and/or balance deficits were randomly allocated to either 5 weeks of C-Mill therapy or the FALLS program. The primary outcome measure was the standard walking speed as determined with the 10-meter walking test (10MWT). Additionally, context-specific walking speed was assessed in environments enriched with either stationary physical context (10MWT context) or suddenly appearing visual images (Interactive Walkway obstacles). The walking-adaptability scores of those enriched walking tests served as secondary outcome measures. Furthermore, a cognitive task was added to all three assessments to evaluate dual-task performance in this context. Finally, the participants' experience and amount of walking practice were scored. The outcome measures were assessed at four test moments: pre-intervention (T0), post-intervention (T1), 5-week post-intervention retention (T2), and 1-year post-intervention follow-up (T3). RESULTS:No significant group differences were found between the interventions for the primary outcome measure standard walking speed, but we found a greater improvement in context-specific walking speed with stationary physical context of the C-Mill therapy compared to the FALLS program at the post-intervention test, which was no longer significant at retention. Both interventions were well received, but C-Mill therapy scored better on perceived increased fitness than the FALLS program. C-Mill therapy resulted in twice as many steps per session of equal duration than the FALLS program. The "change-over-time" analyses for participants of both interventions combined showed no significant improvements in the standard walking speed; however, significant improvements were found for context-specific walking speed, walking adaptability, and cognitive dual-task performance. SIGNIFICANCE:This study showed no between-group differences between the novel treadmill-based C-Mill therapy and the standard overground FALLS program with respect to the primary outcome measure standard walking speed. However, the greater amount of walking practice observed for the C-Mill group, an essential aspect of effective intervention programs after stroke, may underlie the reported increased perceived fitness and observed increased context-specific walking speed for the C-Mill group directly after the intervention. Although the "change-over-time" results for all participants combined showed no improvement in the standard walking speed, context-specific walking speed and walking adaptability showed sustained improvements after the interventions, underscoring the importance of including walking-adaptability training and assessment in rehabilitation post stroke. TRIAL REGISTRATION:The Netherlands Trial Register NTR4030 . Registered 11 June 2013.

SUBMITTER: Timmermans C

PROVIDER: S-EPMC8672482 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundStroke survivors are more physically inactive than even the most sedentary older adults, and low activity is associated with increased risk of recurrent stroke, medical complications, and mortality. We hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone.MethodsUsing a single-blind randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors complete 12 weeks of fast walking training, a step activity monitoring program or a fast walking training + step activity monitoring program. Main eligibility criteria include: chronic ischemic or hemorrhagic stroke (> 6 months post), no evidence of cerebellar stroke, baseline walking speed between 0.3 m/s and 1.0 m/s, and baseline average steps / day < 8000. The primary (steps per day), secondary (self-selected and fastest walking speed, walking endurance, oxygen consumption) and exploratory (vascular events, blood lipids, glucose, blood pressure) outcomes are assessed prior to initiating treatment, after the last treatment and at a 6 and 12-month follow-up. Moderation of the changes in outcomes by baseline characteristics are evaluated to determine for whom the interventions are effective.DiscussionFollowing completion of this study, we will not only understand the efficacy of the interventions and the individuals for which they are effective, we will have the necessary information to design a study investigating the secondary prevention benefits of improved physical activity post-stroke. This study is, therefore, an important step in the development of both rehabilitative and secondary prevention guidelines for persons with stroke.Trial registrationClinicalTrials.gov Identifier: NCT02835313 . First Posted: July 18, 2016.

Project description:BackgroundPhysical inactivity in people with chronic stroke profoundly affects daily function and increases recurrent stroke risk and mortality, making physical activity improvements an important target of intervention. We compared the effects of a highintensity walking intervention (FAST), a step activity monitoring behavioral intervention (SAM), or a combined intervention (FAST+SAM) on physical activity (i.e., steps per day). We hypothesized the combined intervention would yield the greatest increase in steps per day.MethodsThis assessor-blinded multi-site randomized controlled trial was conducted at four university/hospital-based laboratories. Participants were 21-85 years old, walking without physical assistance following a single, unilateral non-cerebellar stroke of ≥6 months duration, and randomly assigned to FAST, SAM, or FAST+SAM for 12 weeks (2-3 sessions/week). FAST training consisted of walking-related activities for 40 minutes/session at 70-80% heart rate reserve, while SAM received daily feedback and goal-setting of walking activity (steps per day). Assessors and study statistician were masked to group assignment.The a priori-determined primary outcome and primary endpoint was change in steps per day from pre- to post-intervention. Adverse events (AEs) were tracked after randomization. All randomized participants were included in the intent-to-treat analysis.This study is registered at ClinicalTrials.gov, NCT02835313.FindingsParticipants were enrolled from July 18, 2016-November 16, 2021. Of 250 randomized participants (mean[SE] age 63[0.80], 116F/134M), 89 were assigned to FAST, 81 to SAM, and 80 to FAST+SAM. Steps per day significantly increased in both the SAM (mean[SE] 1542[267], 95%CI:1014-2069, p<0.001) and FAST+SAM groups (1307[280], 752-1861, p<0.001), but not in the FAST group (406[238], 63-876, p=0.09). There were no deaths or serious study-related AEs and all other minor AEs were similar between groups.InterpretationOnly individuals with chronic stroke who completed a step activity monitoring behavioral intervention with skilled coaching and goal progression demonstrated improvements in physical activity (steps per day).

Project description:BackgroundOccupational therapy (OT) is an effective evidence-based intervention that positively influences stroke patients'independence recovery, leading to new opportunities for better quality of life outcomes.ObjectivesTo explore the effectiveness of an early OT intervention program (EOTIPS) in the process of hospital to home discharge after stroke in Spain.Material and methodsWe conducted a prospective, randomized controlled clinical trial that included 60 adults who suffered a stroke and were discharged home. Participants assigned to the experimental group (n = 30) were included in EOTIPS and compared with a control group (n = 30). Evaluations assessed quality of life (Stroke and Aphasia Quality of Life Scale [SAQOL-39]), functional independence (Modified Rankin Scale [mRS], Barthel Index [BI] and Stroke Impact Scale-16 [SIS-16]), perceptual-cognitive skills (Montreal Cognitive Assessment [MoCA]), upper limb function (Fugl Meyer Assessment [FMA]), mobility (Berg Balance Scale [BBS] and Timed Up & Go [TUG]), communication skills (Communicative Activity Log [CAL]) and mood disorders (Beck Depression Inventory-II [BDI-II] and Hamilton Anxiety Scale [HAM-A]); they were completed within two weeks post-stroke and after three months follow-up. Statistical analysis included intent-to-treat analysis, considering all participants (dropouts as failures), and efficacy analysis, considering only end-of-treatment participants.ResultsParticipants in the intervention group showed a significant better evolution in the main outcome measure of quality of life (SAQOL-39 p = .029), as well as for independence (mRSp = .004), perceptual-cognitive skills (MoCA p = .012)and symptoms of depression (BDI-II p = .011) compared to the control group.ConclusionsEOTIPS was effective in improving quality of life, as well as enhancing perceptual-cognitive skills, independence and reducing levels of depression for patients who suffered a stroke in a Spanish cohort and could be considered as an applicable non-pharmacologic therapeutic tool that can lead to patients' positive outcomes after stroke. This study was registered on ClinicalTrials.gov with the identifier NCT04835363.

Project description:BackgroundPneumonia is among the most common acute complications after stroke and is associated with poor long-term outcome. Biomarkers may help identifying stroke patients at high risk for developing stroke-associated pneumonia (SAP) and to guide early treatment.AimsThis trial investigated whether procalcitonin (PCT) ultrasensitive (PCTus)-guided antibiotic treatment of SAP can improve functional outcome after stroke.MethodsIn this international, multicenter, randomized, controlled clinical trial with blinded assessment of outcomes, patients with severe ischemic stroke in the middle cerebral artery territory were randomly assigned within 40 h after symptom onset to PCTus-based antibiotic therapy guidance in addition to stroke unit care or standard stroke unit care alone. The primary endpoint was functional outcome at 3 months, defined according to the modified Rankin Scale (mRS) and dichotomized as acceptable (≤4) or unacceptable (≥5). Secondary endpoints included usage of antibiotics, infection rates, days of fever, and mortality. The trial was registered with http://ClinicalTrials.gov (Identifier NCT01264549).ResultsIn the intention-to-treat-analysis based on 227 patients (112 in PCT and 115 in control group), 197 patients completed the 3-month follow-up. Adherence to PCT guidance was 65%. PCT-guided therapy did not improve functional outcome as measured by mRS (odds ratio 0.79; 95% confidence interval 0.45-1.35, p = 0.47). Pneumonia rate and mortality were similar in both groups. Days with fever tended to be lower (p = 0.055), whereas total number of days treated with antibiotics were higher (p = 0.004) in PCT compared to control group. A post hoc analysis including all PCT values in the intention-to-treat population demonstrated a significant increase on the first day of infection in patients with pneumonia and sepsis compared to patients with urinary tract infections or without infections (p < 0.0001).ConclusionPCTus-guided antibiotic therapy did not improve functional outcome at 3 months after severe ischemic stroke. PCT is a promising biomarker for early detection of pneumonia and sepsis in acute stroke patients.

Project description:BackgroundPneumonia is a major risk factor of death after acute stroke. In a mouse model, preventive antibacterial therapy with moxifloxacin not only prevents the development of post-stroke infections, it also reduces mortality, and improves neurological outcome significantly. In this study we investigate whether this approach is effective in stroke patients.MethodsPreventive ANtibacterial THERapy in acute Ischemic Stroke (PANTHERIS) is a randomized, double-blind, placebo-controlled trial in 80 patients with severe, non-lacunar, ischemic stroke (NIHSS>11) in the middle cerebral artery (MCA) territory. Patients received either intravenous moxifloxacin (400 mg daily) or placebo for 5 days starting within 36 hours after stroke onset. Primary endpoint was infection within 11 days. Secondary endpoints included neurological outcome, survival, development of stroke-induced immunodepression, and induction of bacterial resistance.FindingsOn intention-to treat analysis (79 patients), the infection rate at day 11 in the moxifloxacin treated group was 15.4% compared to 32.5% in the placebo treated group (p = 0.114). On per protocol analysis (n = 66), moxifloxacin significantly reduced infection rate from 41.9% to 17.1% (p = 0.032). Stroke associated infections were associated with a lower survival rate. In this study, neurological outcome and survival were not significantly influenced by treatment with moxifloxacin. Frequency of fluoroquinolone resistance in both treatment groups did not differ. On logistic regression analysis, treatment arm as well as the interaction between treatment arm and monocytic HLA-DR expression (a marker for immunodepression) at day 1 after stroke onset was independently and highly predictive for post-stroke infections.InterpretationPANTHERIS suggests that preventive administration of moxifloxacin is superior in reducing infections after severe non-lacunar ischemic stroke compared to placebo. In addition, the results emphasize the pivotal role of immunodepression in developing post-stroke infections.Trial registrationControlled-Trials.com ISRCTN74386719.

Project description:RationaleClinical practice guidelines support structured, progressive protocols for improving walking after stroke. Yet, practice is slow to change, evidenced by the little amount of walking activity in stroke rehabilitation units. Our recent study (n = 75) found that a structured, progressive protocol integrated with typical daily physical therapy improved walking and quality-of-life measures over usual care. Research therapists progressed the intensity of exercise by using heart rate and step counters worn by the participants with stroke during therapy. To have the greatest impact, our next step is to undertake an implementation trial to change practice across stroke units where we enable the entire unit to use the protocol as part of standard of care.AimsWhat is the effect of introducing structured, progressive exercise (termed the Walk 'n Watch protocol) to the standard of care on the primary outcome of walking in adult participants with stroke over the hospital inpatient rehabilitation period? Secondary outcomes will be evaluated and include quality of life.Methods and sample size estimatesThis national, multisite clinical trial will randomize 12 sites using a stepped-wedge design where each site will be randomized to deliver Usual Care initially for 4, 8, 12, or 16 months (three sites for each duration). Then, each site will switch to the Walk 'n Watch phase for the remaining duration of a total 20-month enrolment period. Each participant will be exposed to either Usual Care or Walk 'n Watch. The trial will enroll a total of 195 participants with stroke to achieve a power of 80% with a Type I error rate of 5%, allowing for 20% dropout. Participants will be medically stable adults post-stroke and able to take five steps with a maximum physical assistance from one therapist. The Walk 'n Watch protocol focuses on completing a minimum of 30 min of weight-bearing, walking-related activities (at the physical therapists' discretion) that progressively increase in intensity informed by activity trackers measuring heart rate and step number.Study outcome(s)The primary outcome will be the change in walking endurance, measured by the 6-Minute Walk Test, from baseline (T1) to 4 weeks (T2). This change will be compared across Usual Care and Walk 'n Watch phases using a linear mixed-effects model. Additional physical, cognitive, and quality of life outcomes will be measured at T1, T2, and 12 months post-stroke (T3) by a blinded assessor.DiscussionThe implementation of stepped-wedge cluster-randomized trial enables the protocol to be tested under real-world conditions, involving all clinicians on the unit. It will result in all sites and all clinicians on the unit to gain expertise in protocol delivery. Hence, a deliberate outcome of the trial is facilitating changes in best practice to improve outcomes for participants with stroke in the trial and for the many participants with stroke admitted after the trial ends.

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Walking-adaptability therapy after stroke: results of a randomized controlled trial.

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