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Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:After discharge from hospital following a stroke, prescriptions of community-based rehabilitation are often downgraded to "maintenance" rehabilitation or discontinued. This classic therapeutic behavior stems from persistent confusion between lesion-induced plasticity, which lasts for the first 6?months essentially, and behavior-induced plasticity, of indefinite duration, through which intense rehabilitation might remain effective. This prospective, randomized, multicenter, single-blind study in subjects with chronic stroke-induced hemiparesis evaluates changes in active function with a Guided Self-rehabilitation Contract vs conventional therapy alone, pursued for a year. METHODS:One hundred and twenty four adult subjects with chronic hemiparesis (>?1?year since first stroke) will be included in six tertiary rehabilitation centers. For each patient, two treatments will be compared over a 1-year period, preceded and followed by an observational 6-month phase of conventional rehabilitation. In the experimental group, the therapist will implement the diary-based and antagonist-targeting Guided Self-rehabilitation Contract method using two monthly home visits. The method involves: i) prescribing a daily antagonist-targeting self-rehabilitation program, ii) teaching the techniques involved in the program, iii) motivating and guiding the patient over time, by requesting a diary of the work achieved to be brought back by the patient at each visit. In the control group, participants will benefit from conventional therapy only, as per their physician's prescription. The two co-primary outcome measures are the maximal ambulation speed barefoot over 10?m for the lower limb, and the Modified Frenchay Scale for the upper limb. Secondary outcome measures include total cost of care from the medical insurance point of view, physiological cost index in the 2-min walking test, quality of life (SF 36) and measures of the psychological impact of the two treatment modalities. Participants will be evaluated every 6?months (D1/M6/M12/M18/M24) by a blinded investigator, the experimental period being between M6 and M18. Each patient will be allowed to receive any medications deemed necessary to their attending physician, including botulinum toxin injections. DISCUSSION:This study will increase the level of knowledge on the effects of Guided Self-rehabilitation Contracts in patients with chronic stroke-induced hemiparesis. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02202954 , July 29, 2014.

SUBMITTER: Gracies JM

PROVIDER: S-EPMC6419473 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial.

Gracies Jean-Michel JM Pradines Maud M Ghédira Mouna M Loche Catherine-Marie CM Mardale Valentina V Hennegrave Catherine C Gault-Colas Caroline C Audureau Etienne E Hutin Emilie E Baude Marjolaine M Bayle Nicolas N

BMC neurology 20190312 1

<h4>Background</h4>After discharge from hospital following a stroke, prescriptions of community-based rehabilitation are often downgraded to "maintenance" rehabilitation or discontinued. This classic therapeutic behavior stems from persistent confusion between lesion-induced plasticity, which lasts for the first 6 months essentially, and behavior-induced plasticity, of indefinite duration, through which intense rehabilitation might remain effective. This prospective, randomized, multicenter, sin ...[more]

PMID: 30871480

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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:CI therapy is effective in patients with relatively good levels of residual arm function but its applicability to patients with low-functioning hemiparesis is not entirely clear. In the present study, we examined the feasibility and efficacy of the CI therapy concept in patients with very limited upper arm function prior to treatment, and further tested how the length of daily shaping training and constraining the good arm affects treatment outcome. In a baseline-controlled design, 65 chronic patients were treated with 2?weeks of modified CI therapy. Patients were randomly allocated to four treatment groups receiving 90 or 180?min of daily shaping training applied with or without constraint, respectively. Outcome was measured through the Reliable Change Index, which was calculated for parameters of motor function, health, and psychological wellbeing. Follow-up data were collected at 6 and 12?months. Two analyses were conducted, a whole-group analysis across all 65 participants and a sub-group analysis contrasting the four treatment variants. The whole-group analysis showed a significant treatment effect, which was largely sustained after 1?year. The sub-group analysis revealed a mixed picture; while improvements against the baseline period were observed in all four subgroups, 180?min of daily shaping training coupled with the constraint yielded better outcome on the MAL but not the WMFT, while for 90?min of training the level of improvement was similar for those who wore the constraint and those who did not. Together these results suggest that, at least in those patients available for follow-up measures, modified CI therapy induces sustained improvements in motor function in patients with chronic low-functioning hemiparesis. The absence of clear differences between the four treatment variants points to a complex relationship between the length of daily shaping training and the constraint in this patient group, which is likely to be mediated by fatigue and/or compliance with the constraint.

Project description:BackgroundIntensive robot-assisted training of the upper limb after stroke can reduce motor impairment, even at the chronic stage. However, the effectiveness of practice for recovery depends on the selection of the practised movements. We hypothesized that rehabilitation can be optimized by selecting the movements to be practiced based on the trainee's performance profile.MethodsWe present a novel principle ('steepest gradients') for performance-based selection of movements. The principle is based on mapping motor performance across a workspace and then selecting movements located at regions of the steepest transition between better and worse performance. To assess the benefit of this principle we compared the effect of 15 sessions of robot-assisted reaching training on upper-limb motor impairment, between two groups of people who have moderate-to-severe chronic upper-limb hemiparesis due to stroke. The test group (N = 7) received steepest gradients-based training, iteratively selected according to the steepest gradients principle with weekly remapping, whereas the control group (N = 9) received a standard "centre-out" reaching training. Training intensity was identical.ResultsBoth groups showed improvement in Fugl-Meyer upper-extremity scores (the primary outcome measure). Moreover, the test group showed significantly greater improvement (twofold) compared to control. The score remained elevated, on average, for at least 4 weeks although the additional benefit of the steepest-gradients -based training diminished relative to control.ConclusionsThis study provides a proof of concept for the superior benefit of performance-based selection of practiced movements in reducing upper-limb motor impairment due to stroke. This added benefit was most evident in the short term, suggesting that performance-based steepest-gradients training may be effective in increasing the rate of initial phase of practice-based recovery; we discuss how long-term retention may also be improved.Trial registrationISRCTN, ISRCTN65226825 , registered 12 June 2018 - Retrospectively registered.

Project description:Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.

Project description:OBJECTIVE:Chronic stroke patients with severe hand weakness respond poorly to rehabilitation efforts. Here, we evaluated efficacy of daily brain-machine interface (BMI) training to increase the hypothesized beneficial effects of physiotherapy alone in patients with severe paresis in a double-blind sham-controlled design proof of concept study. METHODS:Thirty-two chronic stroke patients with severe hand weakness were randomly assigned to 2 matched groups and participated in 17.8 ± 1.4 days of training rewarding desynchronization of ipsilesional oscillatory sensorimotor rhythms with contingent online movements of hand and arm orthoses (experimental group, n = 16). In the control group (sham group, n = 16), movements of the orthoses occurred randomly. Both groups received identical behavioral physiotherapy immediately following BMI training or the control intervention. Upper limb motor function scores, electromyography from arm and hand muscles, placebo-expectancy effects, and functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent activity were assessed before and after intervention. RESULTS:A significant group × time interaction in upper limb (combined hand and modified arm) Fugl-Meyer assessment (cFMA) motor scores was found. cFMA scores improved more in the experimental than in the control group, presenting a significant improvement of cFMA scores (3.41 ± 0.563-point difference, p = 0.018) reflecting a clinically meaningful change from no activity to some in paretic muscles. cFMA improvements in the experimental group correlated with changes in fMRI laterality index and with paretic hand electromyography activity. Placebo-expectancy scores were comparable for both groups. INTERPRETATION:The addition of BMI training to behaviorally oriented physiotherapy can be used to induce functional improvements in motor function in chronic stroke patients without residual finger movements and may open a new door in stroke neurorehabilitation.

Dataset Information

Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial.

Publications

Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial.

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