Effective rehabilitative therapies are needed for patients with long-term deficits after stroke.
In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe ...upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.
At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval CI, -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.
In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)
Abstract
Background
Evidence-based guidelines are needed to inform rehabilitation practice, including the effect of number of exercise training sessions on recovery of walking ability after stroke.
...Objective
The objective of this study was to determine the response to increasing number of training sessions of 2 interventions—locomotor training and strength and balance exercises—on poststroke walking recovery.
Design
This is a secondary analysis of the Locomotor Experience Applied Post-Stroke (LEAPS) randomized controlled trial.
Setting
Six rehabilitation sites in California and Florida and participants’ homes were used.
Participants
Participants were adults who dwelled in the community (N=347), had had a stroke, were able to walk at least 3 m (10 ft) with assistance, and had completed the required number of intervention sessions.
Intervention
Participants received 36 sessions (3 times per week for 12 weeks), 90 minutes in duration, of locomotor training (gait training on a treadmill with body-weight support and overground training) or strength and balance training.
Measurements
Talking speed, as measured by the 10-Meter Walk Test, and 6-minute walking distance were assessed before training and following 12, 24, and 36 intervention sessions.
Results
Participants at 2 and 6 months after stroke gained in gait speed and walking endurance after up to 36 sessions of treatment, but the rate of gain diminished steadily and, on average, was very low during the 25- to 36-session epoch, regardless of treatment type or severity of impairment.
Limitations
Results may not generalize to people who are unable to initiate a step at 2 months after stroke or people with severe cardiac disease.
Conclusions
In general, people who dwelled in the community showed improvements in gait speed and walking distance with up to 36 sessions of locomotor training or strength and balance exercises at both 2 and 6 months after stroke. However, gains beyond 24 sessions tended to be very modest. The tracking of individual response trajectories is imperative in planning treatment.
We investigated trends in activities of daily living (ADL) and instrumental activities of daily living (IADL) disability from 1998 to 2008 among elder adults in Shanghai, China.
Our data came from 4 ...waves of the Shanghai Longitudinal Survey of Elderly Life and Opinion (1998, 2003, 2005, and 2008). ADL and IADL disabilities were recorded dichotomously (difficulty vs. no difficulty). The major independent variable was survey year. Covariates included demographics, socioeconomic conditions, family and social support, and other health conditions. Nested random-effect models were applied to estimate trends over time, referenced to 1998.
In comparison with the baseline year (1998), older adults in 2008 had lower odds of being ADL disabled, though the effect was no longer statistically significant when other health conditions were taken into account. Elders in 2003, 2005, and 2008 were 20%-26%, 17%-38%, and 53%-64% less likely to be IADL disabled than those in 1998, respectively, depending on the set of covariates included in the model.
Shanghai elders experienced substantial improvements in both ADL and IADL disability prevalence over the past decade. The trend toward improvement in IADL function is more consistent and substantial than that of ADL function.
A range of sleep disturbances and disorders are problematic in people after stroke; they interfere with recovery of function during poststroke rehabilitation. However, studies to date have focused ...primarily on the effects of one sleep disorder-obstructive sleep apnea (OSA)-on stroke recovery.
The study protocol for the SLEep Effects on Poststroke Rehabilitation (SLEEPR) Study is presented with aims of characterizing proportion of non-OSA sleep disorders in the first 90 days after stroke, evaluating the effect of non-OSA sleep disorders on poststroke recovery, and exploring the complex relationships between stroke, sleep, and recovery in the community setting.
SLEEPR is a prospective cohort observational study across multiple study sites following individuals from inpatient rehabilitation through 90 days poststroke, with three measurement time points (inpatient rehabilitation; i.e., ~15 days poststroke, 60 days poststroke, and 90 days poststroke). Measures of sleep, function, activity, cognition, emotion, disability, and participation will be obtained for 200 people without OSA at the study's start through self-report, capacity assessments, and performance measures. Key measures of sleep include wrist actigraphy, sleep diaries, overnight oximetry, and several sleep disorders screening questionnaires (Insomnia Severity Index, Cambridge-Hopkins Restless Legs Questionnaire, Epworth Sleepiness Scale, and Sleep Disorders Screening Checklist). Key measures of function and capacity include the 10-meter walk test, Stroke Impact Scale, Barthel index, and modified Rankin scale. Key performance measures include leg accelerometry (e.g., steps/day, sedentary time, upright time, and sit-to-stand transitions) and community trips via GPS data and activity logs.
The results of this study will contribute to understanding the complex interplay between non-OSA sleep disorders and poststroke rehabilitation; they provide insight regarding barriers to participation in the community and return to normal activities after stroke. Such results could lead to strategies for developing new stroke recovery interventions.
The purpose is to establish a theoretical framework by which new interventions for poststroke rehabilitation may be developed incorporating knowledge of neuroplasticity and the critical ingredients ...of rehabilitation.
Large phase III randomized controlled trials (RCTs) are rare in neurorehabilitation, and the results of those that have been completed are perplexing because the experimental and control treatments were not different when matched for activity level. In addition, the outcome measures used to define treatment effects reflected behavioral endpoints, but did not reveal how neuroplastic mechanisms or other mechanistic factors may have contributed to the treatment response. Knowledge of both the neurophysiologic basis of recovery and key elements of interventions that drive motor learning, such as intensity and task progression, are critical for optimizing future poststroke motor rehabilitation clinical trials.
Future neurorehabilitation RCTs require a better understanding of the interaction of interventions and neurophysiological recovery in order to target interventions at specific neurophysiologic substrates, develop a more clear understanding of the impact of intervention parameters (e.g. dose, intensity), and advance discussions regarding optimal ways to partner medical and rehabilitation interventions in order to improve outcomes.
Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested ...its cost-effectiveness.
We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization.
A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different.
The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00372411.
Abstract
Background and Objectives
Stroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to ...improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
Research Design and Methods
We conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework.
Results
Organizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not “organizationally ready” had more difficulty addressing implementation challenges.
Discussion and Implications
Multifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention.
Clinical Trial Registration
NCT02588664
Stroke is a leading cause of disability with limited effective interventions that improve recovery in the subacute phase. This protocol aims to evaluate the safety and efficacy of a non-invasive, ...extremely low-frequency, low-intensity, frequency-tuned electromagnetic field treatment Electromagnetic Network Targeting Field (ENTF) therapy in reducing disability and promoting recovery in people with subacute ischemic stroke (IS) with moderate-severe disability and upper extremity (UE) motor impairment. Following a sample-size adaptive design with a single interim analysis, at least 150 and up to 344 participants will be recruited to detect a 0.5-point (with a minimum of 0.33 points) difference on the modified Rankin Scale (mRS) between groups with 80% power at a 5% significance level. This ElectroMAGnetic field Ischemic stroke-Novel subacutE treatment (EMAGINE) trial is a multicenter, double-blind, randomized, sham-controlled, parallel two-arm study to be conducted at approximately 20 United States sites, and enroll participants with subacute IS and moderate-severe disability with UE motor impairment. Participants will be assigned to active (ENTF) or sham treatment, initiated 4-21 days after stroke onset. The intervention, applied to the central nervous system, is designed for suitability in multiple clinical settings and at home. Primary endpoint is change in mRS score from baseline to 90 days post-stroke. Secondary endpoints: change from baseline to 90 days post-stroke on the Fugl-Meyer Assessment - UE (lead secondary endpoint), Box and Block Test, 10-Meter Walk, and others, to be analyzed in a hierarchical manner. EMAGINE will evaluate whether ENTF therapy is safe and effective at reducing disability following subacute IS.
www.ClinicalTrials.gov, NCT05044507 (14 September 2021).
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