Neurophysiological and Clinical Effects of Upper Limb Robot-Assisted Rehabilitation on Motor Recovery in Patients with Subacute Stroke: A Multicenter Randomized Controlled Trial Study Protocol

Abstract

Background: The efficacy of upper limb (UL) robot-assisted therapy (RAT) on functional improvement after stroke remains unclear. However, recently published randomized controlled trials have supported its potential benefits in enhancing the activities of daily living, arm and hand function, and muscle strength. Task-specific and high-intensity exercises are key points in facilitating motor re-learning in neurorehabilitation since RAT can provide an assisted-as-needed approach. This study aims to investigate the clinical effects of an exoskeleton robotic system for UL rehabilitation compared with conventional therapy (CT) in people with subacute stroke. As a secondary aim, we seek to identify patients’ characteristics, which can predict better recovery after UL-RAT and detects whether it could elicit greater brain stimulation. Methods: A total of 84 subacute stroke patients will be recruited from 7 Italian rehabilitation centers over 3 years. The patients will be randomly allocated to either CT (control group, CG) or CT plus UL-RT through an Armeo®Power (Hocoma AG, CH, Volketswil, Switzerland) exoskeleton (experimental group, EG). A sample stratification based on distance since onset, DSO (DSO ≤ 30; DSO > 30), and Fugl–Meyer Assessment (FM)-UL (FM-UL ≤ 22; 22 < FM-UL ≤ 44) will be considered for the randomization. The outcomes will be recorded at baseline (T0), after 25 + 3 sessions of intervention (T1), and at 6 months post-stroke (T2). The motor functioning assessed by the FM-UL (0–66) will be considered the primary outcome. The clinical assessments will be set based on the International Classification of Function, Disability and Health (ICF). A patient satisfaction questionnaire will be evaluated in the EG at T1. A subgroup of patients will be evaluated at T0 and T1 via electroencephalography. Their brain electrical activity will be recorded during rest conditions with their eyes closed and open (5 min each). Conclusion: The results of this trial will provide an in-depth understanding of the efficacy of early UL-RAT through a whole arm exoskeleton and how it may relate to the neural plasticity process. The trial was registered at ClinicalTrial.gov with the registration identifier NCT04697368.

RETRACTED: Assessment Capacity of the Armeo® Power: Cross-Sectional Study

“…One of the most used robotic tools is undoubtedly the Armeo ® Power, a robotic rehabilitation exoskeleton for upper limb training. Providing intelligent arm support in a 3D workspace, the Armeo ® Power has proved to have excellent qualities as a rehabilitation tool [19][20][21][22][23][24]. However, none of these studies have investigated the ability of Armeo ® Power to assess the upper limb by correlating the data resulting from the software with PROMs.…”

Electrically Equivalent Head Tissue Materials for Electroencephalogram Study on Head Surrogates

“…These frequencies are known as dominant frequencies and vary depending on different human tasks. These dominant frequencies are divided into ranges such as Alpha (7)(8)(9)(10)(11)(12) [58], Beta (12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) [59], Gamma (25-50 Hz) [60], etc. These ranges are selected considering the fact of human subject variations.…”

“…For the purpose of EEG analysis, electrical conductivities are the most important parameters in accurate source localization and construction [7]. It is also important for the accurate understanding of the electrical activity in the live and postmortem brain tissues using EEG and MEG [8], which is critical to understanding the accurate neurological functions [9], neurological and psychiatric disorders [10], probable treatment [11], and recovery observations [12,13]. As such, the focus here is developing simulant materials with matching conductivities of head tissue materials.…”

Three-Dimensional Magnetic Rehabilitation, Robot-Enhanced Hand-Motor Recovery after Subacute Stroke: A Randomized Controlled Trial

“…Studies investigating the therapeutic effect on motor function after robot-assisted finger-hand rehabilitation in patients with stroke have emphasized the need to use a combination of tools to analyze treatment effects that can adequately assess the degree of hand function in daily life, such as QuickDASH and WMFT, in addition to tools that measure upper-extremity muscle strength, such as the FMA_U and Motricity Index, which measure motor function [27,28]. ADLs are largely dependent on hand function, especially for personal activities, such as feeding, dressing, and grooming [29]. One year after a stroke, hand-function impairment reportedly was associated with reduced awareness of anxiety, health-related quality of life, and subjective well-being [30].…”