A Stroke Recovery Trial Development Framework: Consensus-Based Core Recommendations from the Second Stroke Recovery and Rehabilitation Roundtable

Bernhardt, Julie; Hayward, Kathryn S; Dancause, Numa; Lannin, Natasha A.; Ward, Nick; Nudo, Randolph J.; Farrin, Amanda; Чурилов, Леонид; Boyd, Lara A.; Jones, Theresa A.; Carmichael, S. Thomas; Corbett, Dale; Cramer, Steven C.

doi:10.1177/1545968319888642

Cited by 39 publications

(38 citation statements)

References 41 publications

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“…Building up large stroke brain banks similar as we know it for neurodegenerative disorders would be a large step to be able to link findings from preclinical models to the human situation. “Better alignment of preclinical studies to clinical realities or constraints should be a priority for the field and funding bodies” as formulated by the Second Stroke Recovery and Rehabilitation Roundtable 127 may cover only one side of the medal. Even if well and thoroughly designed, preclinical and here in particular rodent models have their inherent specifics and limitations.…”

Section: Discussionmentioning

confidence: 99%

Principles and requirements for stroke recovery science

Sommer

Schäbitz

2020

J Cereb Blood Flow Metab

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The disappointing results in bench-to-bedside translation of neuroprotective strategies caused a certain shift in stroke research towards enhancing the endogenous recovery potential of the brain. One reason for this focus on recovery is the much wider time window for therapeutic interventions which is open for at least several months. Since recently two large clinical studies using d-amphetamine or fluoxetine, respectively, to enhance post-stroke neurological outcome failed again it is a good time for a critical reflection on principles and requirements for stroke recovery science. In principal, stroke recovery science deals with all events from the molecular up to the functional and behavioral level occurring after brain ischemia eventually ending up with any measurable improvement of various clinical parameters. A detailed knowledge of the spontaneously occurring post-ischemic regeneration processes is the indispensable prerequisite for any therapeutic approaches aiming to modify these responses to enhance post-stroke recovery. This review will briefly illuminate the molecular mechanisms of post-ischemic regeneration and the principle possibilities to foster post-stroke recovery. In this context, recent translational approaches are analyzed. Finally, the principal and specific requirements and pitfalls in stroke recovery research as well as potential explanations for translational failures will be discussed.

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Section: Discussionmentioning

confidence: 99%

Principles and requirements for stroke recovery science

Sommer

Schäbitz

2020

J Cereb Blood Flow Metab

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“…1 In humans, the interaction between treatment onset and intensity remains unclear. 2 It has been suggested that reducing daily treatment duration below 3 hours at the acute and subacute stages leads to a poorer prognosis, 3 while there may also be an upper bound beyond which high-intensity motor rehabilitation at the acute stage might lead to unwanted side effects. 4 Designing optimal rehabilitation treatment programmes for stroke patients will not be possible until we understand 'how much', 'when' and 'what' treatment should be delivered.…”

Section: Introductionmentioning

confidence: 99%

Relationship between intensity and recovery in post-stroke rehabilitation: a retrospective analysis

Ballester

Ward

Brander

et al. 2021

J Neurol Neurosurg Psychiatry

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“…However, robot-assisted therapy has so far typically been applied in the context of short (frequently outpatient) therapy sessions in clinical settings (Lum et al, 2012;Page et al, 2013;Klamroth-Marganska et al, 2014), and where the presence of a supervising therapist is required to prepare and manage the complex equipment, set up the patient on/in the device and configure the appropriate therapy plan. This generates organizational and economical constraints that restrict the use of the technology (Wagner et al, 2011;Schneider et al, 2016;Rodgers et al, 2019;Ward et al, 2019) and, as a result, despite claiming high intensity (Lo et al, 2010;Rodgers et al, 2019), the therapy dose achieved using robots remains limited compared to guidelines (Bernhardt et al, 2019) and preclinical evidence (Nudo and Milliken, 1996).…”

Section: Introductionmentioning

confidence: 99%

Towards a platform for robot-assisted minimally-supervised therapy of hand function: design and pilot usability evaluation

Ranzani

Eicher

Viggiano

et al. 2021

Preprint

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BackgroundRobot-assisted therapy can increase therapy dose after stroke, which is often considered insufficient in clinical practice and after discharge, especially with respect to hand function. Thus far, there has been a focus on rather complex systems that require therapist supervision. To better exploit the potential of robot-assisted therapy, we propose a platform designed for minimal therapist supervision, and present the preliminary evaluation of its immediate usability, one of the main and frequently neglected challenges for real-world application. Such an approach could help increase therapy dose by allowing the training of multiple patients in parallel by a single therapist, as well as independent training in the clinic or at home.MethodsWe implemented design changes on a hand rehabilitation robot, considering aspects relevant to enabling minimally-supervised therapy, such as new physical/graphical user interfaces and two functional therapy exercises to train hand motor coordination, somatosensation and memory. Ten participants with chronic stroke assessed the usability of the platform and reported the perceived workload during a single therapy session with minimal supervision. The ability to independently use the platform was evaluated with a checklist.ResultsParticipants were able to independently perform the therapy session after a short familiarization period, requiring assistance in only 13.46(7.69-19.23)% of the tasks. They assigned good-to-excellent scores on the SUS to the user-interface and the exercises (85.00(75.63-86.88) and 73.75(63.13-83.75) out of 100, respectively). Nine participants stated that they would use the platform frequently. Perceived workloads lay within desired workload bands. Object grasping with simultaneous control of forearm pronosupination and stiffness discrimination were identified as the most difficult tasks.DiscussionOur findings demonstrate that a robot-assisted therapy device can be rendered safely and intuitively usable upon first exposure with minimal supervision through compliance with usability and perceived workload requirements. The preliminary usability evaluation identified usability challenges that should be solved to allow real-world minimally-supervised use. Such a platformcould complement conventional therapy, allowing to provide increased dose with the available resources, and establish a continuum of care that progressively increases therapy lead of the patient from the clinic to the home.

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A Stroke Recovery Trial Development Framework: Consensus-Based Core Recommendations from the Second Stroke Recovery and Rehabilitation Roundtable

Cited by 39 publications

References 41 publications

Principles and requirements for stroke recovery science

Principles and requirements for stroke recovery science

Relationship between intensity and recovery in post-stroke rehabilitation: a retrospective analysis

Towards a platform for robot-assisted minimally-supervised therapy of hand function: design and pilot usability evaluation

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