Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)

Mizuno, Katsuhiro; Abe, Takayuki; Ushiba, Junichi; Kawakami, Michiyuki; Ohwa, Tomomi; Hagimura, Kazuto; Ogura, Mariko; Okuyama, Kohei; Fujiwara, Toshiyuki; Liu, Meigen

doi:10.2196/12339

Cited by 10 publications

(8 citation statements)

References 58 publications

(69 reference statements)

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“…This study was a secondary analysis of data from previous randomized, controlled trials or clinical trials (23)(24)(25)(26). Outlines of each study, including ethical approval and clinical trial registration numbers, are provided as Supplementary Material.…”

Section: Methodsmentioning

confidence: 99%

“…Participants received hybrid assistive neuromuscular dynamic stimulation (HANDS) therapy (23) or participated in other randomized, controlled trials or clinical trials (24)(25)(26). The common characteristics of the population were as follows: the time from stroke onset was longer than 180 days; participants had the ability to walk independently with/without…”

Section: Participantsmentioning

confidence: 99%

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Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment

et al. 2020

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Background and Purpose: Limited research has been conducted with the aim of understanding which upper extremity movements are difficult for persons with severe chronic stroke. The purpose of this study was to test the structure of the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) using Rasch analysis in persons with chronic stroke with moderate to severe deficits and to determine the item difficulty hierarchy. Methods: This was a secondary analysis of data from previous randomized, controlled trials, or clinical trials. The participants were 101 persons with chronic stroke with moderate to severe hemiparesis (time after onset of stroke, 1375.3 ± 1157.9 days; the 33-item FMA-UE, 31.1 ± 12.8). Principal component analysis and infit statistics were used to evaluate dimensionality. Rasch analysis using a rating scale model was performed, and item difficulty was determined. Results: Six misfit items were removed. The results showed that the 27-item FMA-UE was unidimensional. Rasch analysis showed that the movements performed within synergies were among the easiest items. Shoulder and elbow movements were among the easiest items, whereas forearm and wrist movements were among the moderately to most difficult items. Hand items spanned various difficulty levels. Discussion and Conclusions: The FMA-UE is a valid assessment tool of upper extremity motor function in persons with chronic stroke with moderate to severe deficits. The results showed that item difficulty was consistent with the stepwise recovery course proposed by Fugl-Meyer. The movements that are difficult for patients with moderate to severe chronic paresis were determined, which would enable comparison of each movement using a measure of motion difficulty in future studies.

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Section: Methodsmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment

et al. 2020

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“…This research was conducted in parallel with previous randomized, controlled trials or clinical trials (37)(38)(39)(40) of rehabilitation of the paretic UE. In this study, all persons who had participated in these trials at Keio University Hospital, Tokyo, Japan, were recruited consecutively from September 2017 to October 2018 until 50 participants were recruited.…”

Section: Participantsmentioning

confidence: 99%

“…Moreover, patients with suspected deficits of active kinesthesia in the non-affected UE were excluded. The outlines of the studies, including detailed inclusion/exclusion criteria, are presented in the respective reports (37)(38)(39)(40). One of the authors extracted the demographic data from the medical records of the participants.…”

Section: Participantsmentioning

confidence: 99%

Validity and Reliability of the Semmes-Weinstein Monofilament Test and the Thumb Localizing Test in Patients With Stroke

et al. 2021

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Background: Somatosensory impairment is common in patients who have had a stroke and can affect their motor function and activities of daily living (ADL). Therefore, detecting and treating somatosensory impairments properly is considered to be very important, and various examinations have been developed. However, the reliability and validity of few of them have been verified due to differences in the procedure of each examiner or poor quantification by the examination itself.Objective: We hypothesized that, with fixed procedures two convenient clinical examinations, the Semmes-Weinstein Monofilament Test (SWMT) and the Thumb Localizing Test (TLT), could provide reliable assessments of light touch sensation and proprioception. The purpose of this study was to verify the reliability and validity of these two examinations as indices of somatosensory impairment of the upper extremity (UE) in patients with chronic post-stroke hemiparesis.Methods: Fifty patients with chronic stroke (median time after onset of stroke, 848 [474–1708] days, mean age 57 [standard deviation 14] years) were enrolled at Keio University Hospital from 2017 to 2018. Examiners learned the original method of the SWMT and the TLT rigorously and shared it with each other. The TLT procedure was partially modified by dividing the location of the patient's thumb into four spaces. Two examiners evaluated the SWMT and the TLT for 2 days, and intra-rater and inter-rater reliabilities were calculated using weighted kappa statistics. In addition to this, the evaluator size score of the SWMT was assessed with Bland-Altman analysis to evaluate systematic bias. The Stroke Impairment Assessment Set (SIAS) sensory items were used to assess validity, and Spearman's rank correlation coefficients were calculated.Results: Intra/inter-rater agreements of the SWMT grade score were 0.89 (thumb, 95%CI: 0.83–0.95)/ 0.75 (0.60–0.91) and 0.80 (index finger, 0.67–0.93)/0.79 (0.66–0.92), and of the TLT they were 0.83 (navel level proximal space, 0.71–0.95)/ 0.83 (0.73–0.92), 0.90 (navel level distal space, 0.85–0.96)/ 0.80 (0.69–0.90), 0.80 (shoulder level proximal space, 0.68–0.92)/ 0.77 (0.65–0.89), and 0.87 (shoulder level distal space, 0.80–0.93)/ 0.80 (0.68–0.92) (P < 0.001, each item). All of them showed substantial agreement, but the MDC of the SWMT evaluator size was 1.28 to 1.79 in the inter-rater test and 1.94–2.06 in the intra-rater test. The SWMT grade score showed a strong correlation with the SIAS light touch sensation item (r = 0.65, p < 0.001), as did the TLT with the SIAS position sense item (r = −0.70–0.62, p < 0.001 each space).Conclusions: The reliability and validity of the SWMT and the TLT were verified. These tests can be used as reliable sensory examinations of the UE in patients with chronic stroke, and especially for the SWMT, it is more reliable for screening.

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“…Although MA-and MI-BCI have been both widely but, respectively, researched (Bundy et al, 2017), the overall analysis and research on the BCI accuracy of MA tasks have not been done in patients with hemiplegia, especially compared further with MI tasks. Mizuno et al (2018) proposed a protocol to compare MA-BCI and MI-controlled treatment to explore the efficacy of MA-BCI in stroke patients but no results have been reported yet. Blokland et al (2014) used EEG and functional near-infrared spectroscopy (fNIRS) to test the feasibility of using MA instead of MI as a task for brain switch control.…”

Section: Introductionmentioning

confidence: 99%

The Differences Between Motor Attempt and Motor Imagery in Brain-Computer Interface Accuracy and Event-Related Desynchronization of Patients With Hemiplegia

et al. 2021

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Background: Motor attempt and motor imagery (MI) are two common motor tasks used in brain-computer interface (BCI). They are widely researched for motor rehabilitation in patients with hemiplegia. The differences between the motor attempt (MA) and MI tasks of patients with hemiplegia can be used to promote BCI application. This study aimed to explore the accuracy of BCI and event-related desynchronization (ERD) between the two tasks.Materials and Methods: We recruited 13 patients with stroke and 3 patients with traumatic brain injury, to perform MA and MI tasks in a self-control design. The BCI accuracies from the bilateral, ipsilesional, and contralesional hemispheres were analyzed and compared between different tasks. The cortical activation patterns were evaluated with ERD and laterality index (LI).Results: The study showed that the BCI accuracies of MA were significantly (p < 0.05) higher than MI in the bilateral, ipsilesional, and contralesional hemispheres in the alpha-beta (8–30 Hz) frequency bands. There was no significant difference in ERD and LI between the MA and MI tasks in the 8–30 Hz frequency bands. However, in the MA task, there was a negative correlation between the ERD values in the channel CP1 and ipsilesional hemispheric BCI accuracies (r = −0.552, p = 0.041, n = 14) and a negative correlation between the ERD values in channel CP2 and bilateral hemispheric BCI accuracies (r = −0.543, p = 0.045, n = 14). While in the MI task, there were negative correlations between the ERD values in channel C4 and bilateral hemispheric BCI accuracies (r = −0.582, p = 0.029, n = 14) as well as the contralesional hemispheric BCI accuracies (r = −0.657, p = 0.011, n = 14). As for motor dysfunction, there was a significant positive correlation between the ipsilesional BCI accuracies and FMA scores of the hand part in 8–13 Hz (r = 0.565, p = 0.035, n = 14) in the MA task and a significant positive correlation between the ipsilesional BCI accuracies and FMA scores of the hand part in 13–30 Hz (r = 0.558, p = 0.038, n = 14) in the MI task.Conclusion: The MA task may achieve better BCI accuracy but have similar cortical activations with the MI task. Cortical activation (ERD) may influence the BCI accuracy, which should be carefully considered in the BCI motor rehabilitation of patients with hemiplegia.

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Evaluating the Effectiveness and Safety of the Electroencephalogram-Based Brain-Machine Interface Rehabilitation System for Patients With Severe Hemiparetic Stroke: Protocol for a Randomized Controlled Trial (BEST-BRAIN Trial)

Cited by 10 publications

References 58 publications

Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment

Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment

Validity and Reliability of the Semmes-Weinstein Monofilament Test and the Thumb Localizing Test in Patients With Stroke

The Differences Between Motor Attempt and Motor Imagery in Brain-Computer Interface Accuracy and Event-Related Desynchronization of Patients With Hemiplegia

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