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A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Stroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with predetermined course content, interval, and pace. We hypothesize that computerized rehabilitation might be improved if a program could customize course content and pace in response to patient-specific progress. The present pilot study is a randomized controlled double-blind crossover clinical trial aiming to study if chronic stroke patients with cognitive impairment could benefit from cognitive training through a customized tele-rehabilitation platform ("Guttmann, NeuroPersonalTrainer"®, GNPT®). METHODS/DESIGN:Individuals with chronic-stage stroke will be recruited. Participants will be randomized to receive experimental intervention (customized tele-rehabilitation platform, GNPT®) or sham intervention (ictus.online), both with the same frequency and duration (five sessions per week over 6 weeks). After a washout period of 3 months, crossover will occur and participants from the GNPT® condition will receive sham intervention, while participants originally from the sham intervention will receive GNPT®. Patients will be assessed before and after receiving each treatment regimen with an exhaustive neuropsychological battery. Primary outcomes will include rating measures that assess attention difficulties, memory failures, and executive dysfunction for daily activities, as well as performance-based measures of attention, memory, and executive functions. DISCUSSION:Customized cognitive training could lead to better cognitive function in patients with chronic-stage stroke and improve their quality of life. TRIAL REGISTRATION:NCT03326349 . Registered 31 October 2017.

SUBMITTER: Gil-Pages M

PROVIDER: S-EPMC5863836 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial.

Gil-Pagés Macarena M Solana Javier J Sánchez-Carrión Rocío R Tormos Jose M JM Enseñat-Cantallops Antonia A García-Molina Alberto A

Trials 20180322 1

<h4>Background</h4>Stroke patients usually suffer primary cognitive impairment related to attention, memory, and executive functions. This impairment causes a negative impact on the quality of life of patients and their families, and may be long term. Cognitive rehabilitation has been shown to be an effective way to treat cognitive impairment and should be continued after hospital discharge. Computerized cognitive rehabilitation can be performed at home using exercise programs that advance with ...[more]

PMID: 29566766

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Project description:BACKGROUND:Cognitive and mood disorders negatively impact daily life in patients with multiple sclerosis (MS). Pharmacological treatments did not demonstrate any effect on cognition compared with cognitive rehabilitation (CR). However, if CR programs offer promising results on cognition, they are less consistent concerning mood and quality of life (QoL). In this context, we designed a randomized controlled trial to evaluate the efficacy of an innovative computerized CR program, conducted at home, on QoL. Secondary objectives will estimate the improvement, or the stabilization over time, of patients' cognitive performances and their emotional affects. METHODS:Forty MS patients (relapsing-remitting or secondary progressive forms) who have cognitive impairment will be recruited for the trial (called SEPIA-NCT03471338) and randomly assigned to either the experimental group or the control group. Patients randomly assigned in the experimental group will perform a home-based CR program with psychological support during eight consecutive weeks. CR will be based on computerized cognitive exercises from the PRESCO® software developed by HAPPYneuron©. Training sessions (three sessions of 45?min per week) will consist of short exercises evaluating a broad range of cognitive domains and will be personalized for each patient (tracking tool and supervised guidance). The control group, designed to control for non-specific elements of the intervention, will receive only psychological support consisting of various issues related to MS, such as everyday cognitive-related difficulties or management of emotions. QoL, assessed by the MUSIQOL (Multiple Sclerosis International Quality Of Life) questionnaire, will be evaluated three times (at baseline and after 1?week and 25?weeks after home-based intervention) as well as secondary outcomes measuring self-esteem, cognition, depression, anxiety, metacognition, fatigue, and sleep quality. Given the expected MUSIQOL variation, the inclusion of 20 patients per group (alpha risk 5% and power 80%) will be required. DISCUSSION:Evidence suggests that computerized programs may be a practice option for CR for people with MS, but there is a paucity of studies evaluating QoL. We hope that this innovative program will highlight such benefits over time in patients' daily life. In the future, such programs will allow a wider range of available therapeutic options for MS patients with cognitive impairment and for practitioners in charge of their care. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT03471338. Retrospectively registered on 25 April 2018. https://clinicaltrials.gov/ct2/show/NCT03471338?term=NCT03471338&cond=Multiple+Sclerosis&draw=2&rank=1 .

Project description:Aims: Continuity of care is an important issue in healthcare for persons after stroke. The present multi-center pilot study investigates the feasibility and efficiency of an innovative approach, the Human Empowerment Aging and Disability (HEAD), for digital-health motor and cognitive rehabilitation. The approach is explored within an in-clinic context (ClinicHEAD) and in continuity of care (HomeHEAD) for persons after chronic stroke. Methods: Thirty-four outpatients with chronic stroke (mean age 55 years, SD 13.7) participated. The HEAD VR protocol was administered in two consecutive phases: Phase I in clinic (ClinicHEAD) consisting of 4 weeks of 12 supervised HEAD rehabilitation sessions (45-min), including motor, cognitive and dual task for all participants; Phase II at home (HomeHEAD) consisted of 60 sessions of the same VR activities, 5 times/week for 3 months. All participants in the ClinicHEAD were allocated (ratio 1:2) to continue with tele-monitored home rehabilitation (HH, N = 11) or to follow usual care (UC, N = 23). Blind evaluation was carried out at baseline, after ClinicHEAD, after 3 months of HomeHEAD and at 3 months Follow-up. Primary outcomes were functional mobility [2-min Walking Test (2MWT)] and cognition [Montreal Cognitive Assessment (MoCA)]. Feasibility and acceptance were assessed with adherence to treatment and the System Usability Satisfaction. Within group analyses were done with dependent samples t-tests, and between groups HomeHEAD comparisons were carried out on change scores with independent samples t-test (p = 0.05, two tailed). Results: The HEAD protocol was feasible with good adherence both in the ClinicHEAD phase (92%) and HomeHEAD (89%) phase, along with good perceived system satisfaction. ClinicHEAD resulted in a significant increase in functional mobility (2MWT, p = 0.02) and cognition (MoCA, p = 0.003) and most secondary outcome variables. At 3 months follow up of HomeHEAD the HH_group showed a further significantly greater maintenance of functional mobility with respect to UC_group (p = 0.04). Conclusion: The HEAD VR protocol was feasible in clinical and at home tele-rehabilitation for persons in the chronic phase after stroke. In clinic the approach was effective in augmenting motor and cognitive abilities and at home it was effective in longterm maintenance of functional mobility, indicating its usefulness in continuity of care. Clinical Trial Registration: ClinicalTrials.gov, NCT03025126.

Project description:BackgroundConstraint-Induced Movement therapy (CI therapy) is shown to reduce disability, increase use of the more affected arm/hand, and promote brain plasticity for individuals with upper extremity hemiparesis post-stroke. Randomized controlled trials consistently demonstrate that CI therapy is superior to other rehabilitation paradigms, yet it is available to only a small minority of the estimated 1.2 million chronic stroke survivors with upper extremity disability. The current study aims to establish the comparative effectiveness of a novel, patient-centered approach to rehabilitation utilizing newly developed, inexpensive, and commercially available gaming technology to disseminate CI therapy to underserved individuals. Video game delivery of CI therapy will be compared against traditional clinic-based CI therapy and standard upper extremity rehabilitation. Additionally, individual factors that differentially influence response to one treatment versus another will be examined.MethodsThis protocol outlines a multi-site, randomized controlled trial with parallel group design. Two hundred twenty four adults with chronic hemiparesis post-stroke will be recruited at four sites. Participants are randomized to one of four study groups: (1) traditional clinic-based CI therapy, (2) therapist-as-consultant video game CI therapy, (3) therapist-as-consultant video game CI therapy with additional therapist contact via telerehabilitation/video consultation, and (4) standard upper extremity rehabilitation. After 6-month follow-up, individuals assigned to the standard upper extremity rehabilitation condition crossover to stand-alone video game CI therapy preceded by a therapist consultation. All interventions are delivered over a period of three weeks. Primary outcome measures include motor improvement as measured by the Wolf Motor Function Test (WMFT), quality of arm use for daily activities as measured by Motor Activity Log (MAL), and quality of life as measured by the Quality of Life in Neurological Disorders (NeuroQOL).DiscussionThis multi-site RCT is designed to determine comparative effectiveness of in-home technology-based delivery of CI therapy versus standard upper extremity rehabilitation and in-clinic CI therapy. The study design also enables evaluation of the effect of therapist contact time on treatment outcomes within a therapist-as-consultant model of gaming and technology-based rehabilitation.Trial registrationClinicaltrials.gov, NCT02631850 .

Project description:Many survivors of stroke report attentional impairments, such as diminished concentration and distractibility. However, the effectiveness of cognitive rehabilitation for improving these impairments is uncertain.This is an update of the Cochrane Review first published in 2000 and previously updated in 2013. To determine whether people receiving cognitive rehabilitation for attention problems 1. show better outcomes in their attentional functions than those given no treatment or treatment as usual, and 2. have a better functional recovery, in terms of independence in activities of daily living, mood, and quality of life, than those given no treatment or treatment as usual. We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, PsycBITE, REHABDATA and ongoing trials registers up to February 2019. We screened reference lists and tracked citations using Scopus. We included controlled clinical trials (CCTs) and randomised controlled trials (RCTs) of cognitive rehabilitation for impairments of attention for people with stroke. We did not consider listening to music, meditation, yoga, or mindfulness to be a form of cognitive rehabilitation. We only considered trials that selected people with demonstrable or self-reported attentional deficits. The primary outcomes were measures of global attentional functions, and secondary outcomes were measures of attentional domains (i.e. alertness, selective attention, sustained attention, divided attention), functional abilities, mood, and quality of life. Two review authors independently selected trials, extracted data, and assessed the risk of bias. We used the GRADE approach to assess the certainty of evidence for each outcome. We included no new trials in this update. The results are unchanged from the previous review and are based on the data of six RCTs with 223 participants. All six RCTs compared cognitive rehabilitation with a usual care control. Meta-analyses demonstrated no convincing effect of cognitive rehabilitation on subjective measures of attention either immediately after treatment (standardised mean difference (SMD) 0.53, 95% confidence interval (CI) -0.03 to 1.08; P = 0.06; 2 studies, 53 participants; very low-quality evidence) or at follow-up (SMD 0.16, 95% CI -0.23 to 0.56; P = 0.41; 2 studies, 99 participants; very low-quality evidence). People receiving cognitive rehabilitation (when compared with control) showed that measures of divided attention recorded immediately after treatment may improve (SMD 0.67, 95% CI 0.35 to 0.98; P < 0.0001; 4 studies, 165 participants; low-quality evidence), but it is uncertain that these effects persisted (SMD 0.36, 95% CI -0.04 to 0.76; P = 0.08; 2 studies, 99 participants; very low-quality evidence). There was no evidence for immediate or persistent effects of cognitive rehabilitation on alertness, selective attention, and sustained attention. There was no convincing evidence for immediate or long-term effects of cognitive rehabilitation for attentional problems on functional abilities, mood, and quality of life after stroke. The effectiveness of cognitive rehabilitation for attention deficits following stroke remains unconfirmed. The results suggest there may be an immediate effect after treatment on attentional abilities, but future studies need to assess what helps this effect persist and generalise to attentional skills in daily life. Trials also need to have higher methodological quality and better reporting.

Project description:IntroductionStroke and its long-term consequences pose major challenges for the lives of those affected and healthcare systems. Neurological rehabilitation therefore primarily attempts to improve function in order to increase independence in activities of daily living, and to enable social participation. There is only scarce data on dynamics of functional recovery after patients discharge from inpatient neurological rehabilitation. Even less is known about the patient's perspective on long-term recovery from stroke. The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE) aims to address this knowledge gap by providing new insights into the dynamics and extent of functional recovery from stroke beyond inpatient rehabilitation treatment.MethodsWe provide the protocol for an observational, longitudinal, multicenter study conducted in an Universitary Stroke Center in cooperation with five Neurological Rehabilitation Centers in Northern Germany. Patients who suffered from ischemic or hemorrhagic stroke will be enrolled by the end of inpatient rehabilitation and followed up to 1 year. In addition, a group of chronic stroke patients and a group of craniocerebral trauma patients will be enrolled as a comparison group. Data on stroke characteristics, vascular risk factors, co-morbidities, social support, and demographics will be recorded. Comprehensive clinical evaluation will be performed at baseline, three, six, and twelve months after enrollment. The assessments and scores used reflect the three components of the International Classification of Functioning, Disability and Health (ICF), some of them are tests regularly used in rehabilitation settings. Tests of motor function, cognition, and mood are included, as are tests of self-reported health-related quality of life. Primary outcome measure is a hand motor score, built by the sum of the hand items of the Fugl-Meyer Assessment as an objective measurement of hand function at 12?months after enrollment. Predictors of the primary outcome will be analyzed using linear regression analysis.PerspectiveThe results of IMPROVE will inform about the long-term dynamics of functional stroke recovery after patients' discharge from inpatient rehabilitation and will provide insights into the association of clinical and demographic factors with recovery of function.Trial registrationThe protocol is registered at ClinicalTrials.gov (NCT04119479).

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A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial.

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A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial.

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