Comparison of tendon and muscle belly vibratory stimulation in the treatment of post-stroke upper extremity spasticity: a retrospective observational pilot study.

Previous studies have reported the effects of vibratory stimulation (VS) therapy in reducing upper extremity spasticity after stroke. However, the effective location of the VS in patients with stroke remains unclear. This study aimed to determine the VS location that is most effective in reducing post-stroke finger and wrist flexor spasticity. We enrolled 27 consecutive patients with stroke and upper extremity spasticity in this retrospective observational study. The participants received stretching, tendon vibration, and muscle belly vibration for 5 min over a period of 3 days. To evaluate spasticity, we assessed the Modified Ashworth Scale score before and immediately after each treatment and immediately after voluntary finger flexion. Participants who received tendon vibration showed greater improvement in flexor tone in the fingers than participants who received stretching and muscle belly vibration (P < 0.05 and < 0.001, respectively). Participants who underwent VS showed no significant improvement in the wrist flexor tone compared to those who underwent stretching. Our results suggest that the tendon may be the most effective location for treating spasticity of the finger flexor muscles and that VS may not significantly improve spasticity of the wrist flexors more than stretching.

Estimating the minimal clinically important difference of upper extremity outcome measures in chronic stroke patients with moderate to severe impairment: a cross-sectional study.

BACKGROUND: Approximately 70% of chronic stroke patients experience upper extremity (UE) functional impairments, and UE outcome measures are often used as quality-of-life indicators. OBJECTIVE: The purpose of this study was to estimate minimal clinically important difference (MCID) values for UE outcome measures in chronic stroke patients with moderate to severe UE hemiplegia. METHODS: This study was a cross-sectional study, conducted as a secondary analysis of data from the ReoGo-J study, a multicenter, prospective, randomized, parallel-group trial of robot-assisted self-training for UE hemiplegia in chronic stroke. The patients were randomized to 1 of 3 treatment groups. Treatment was provided 3 times a week for 10 weeks, and UE outcome measures were evaluated before and after treatment. The anchor-based method was used to estimate MCID values for UE outcome measures, with Stroke Impact Scale (SIS) subscales as anchors. MCID values were estimated by identifying cutoff values in a receiver operating characteristic (ROC) curve. RESULTS: Between-group comparisons of UE outcome measures, based on the clinically important difference (CID) values of SIS subscales, revealed significant differences in both the Amount of Use (AOU) and Quality of Movement (QOM) components of the Motor Activity Log (MAL)-14. The estimated MCID values were 0.89 for the AOU component and 0.77 for the QOM component. CONCLUSIONS: The estimated MCID values for the MAL-14 not only add information regarding the clinical characteristics of the MAL-14 but also facilitate interpretations of changing scores in chronic stroke patients with moderate to severe UE hemiplegia undergoing rehabilitation therapy. STUDY REGISTRATION: https://www.umin.ac.jp/ctr/index.htm (UMIN000022509; 1 July 2016).

Development of the Japanese version of the awareness questionnaire for assessment of self-awareness after acquired brain injury: reliability and validity.

BACKGROUND: The evaluation of impaired self-awareness (ISA) after brain injury is not widespread in Japan, and there is a lack of Japanese assessments of self-awareness. OBJECTIVES: To translate the original version of the Awareness Questionnaire (AQ), an instrument for assessing ISA, into Japanese using a validated method and examine its reliability and validity in inpatients with stroke. METHODS: This cross-sectional, prospective study enrolled 130 participants. The double-translation process was used to develop the Japanese version of the AQ. RESULTS: Data were collected from 120 patients. High intra-rater reliability was observed for the patient (Cronbach's α = 0.824) and clinician samples (Cronbach's α = 0.933). High intra- and inter-rater reliability were found for all AQ items [interclass coefficient (ICC) (1, 1) = 0.828, ICC (2, 1) = 0.852, ICC (3, 1) = 0.848]; however, the sub-item analysis revealed only moderate reliability. Validity assessment revealed a low but significant positive correlation (r = 0.209; p < 0.05) between the Japanese version of the AQ and the Japanese version of the Self-Regulation Skills Interview and a low but significant negative correlation (r = 0.197; p < 0.05) between the Japanese version of the AQ and the Mini-Mental State Examination. CONCLUSIONS: The Japanese version of the AQ was developed and applied to stroke patients, but the concept of post-stroke ISA may differ from ISA after traumatic brain injury, highlighting the need for a stroke-specific version of the AQ.

Therapeutic effect of adjuvant therapy added to constraint-induced movement therapy in patients with subacute to chronic stroke: a systematic review and meta-analysis.

PURPOSE: This review investigated the effectiveness of adjuvant therapy combined with constraint-induced movement therapy (CIMT) in improving the paretic upper limb functionality in adults with stroke sequelae during the subacute to chronic rehabilitation phase. MATERIALS AND METHODS: In this systematic review and meta-analysis of randomized controlled trials (RCT), electronic databases, including PubMed, Web of Science, CINAHL, and MEDLINE, were searched. We included RCTs that investigated the outcomes of adjuvant therapy (i.e. other therapies) added to CIMT compared with CIMT alone. Key trial findings were qualitatively synthesized and analyzed. This meta-analysis examined variables, such as mean scores and standard deviations, using the following outcome measures: Fugl-Meyer Assessment (FMA) upper limb items, Action Research Arm Test (ARAT), Amount of Use (AOU) of Motor Activity Log (MAL), and Quality of Movement (QOM) of MAL. RESULTS: Eighteen eligible RCTs were included in the analysis. Adding CIMT to adjunctive therapy significantly improved FMA compared with CIMT alone (mean difference [MD] 4.02, 95% confidence interval [CI] 2.60-5.44; I2 = 85%; 15 studies; 330 participants). Similarly, the ARAT and MAL-AOU scores improved significantly. CONCLUSIONS: CIMT combined with several adjunctive therapies effectively improved upper limb function.

In recent years, clinical trials combining other therapies with Constraint-induced movement therapy (CIMT) have become increasingly common.This study shows that combining CIMT with adjuvant therapy improves upper limb function.Different protocols of the CIMT in each study could be factor that impacted the results of Motor Activity Log.In clinical practice, the findings of this study into their treatment protocols to improve patient outcomes and ensure the effective application of evidence-based rehabilitation strategies.

Development of a program to determine optimal settings for robot-assisted rehabilitation of the post-stroke paretic upper extremity: a simulation study.

Robot-assisted therapy can effectively treat upper extremity (UE) paralysis in patients who experience a stroke. Presently, UE, as a training item, is selected according to the severity of the paralysis based on a clinician's experience. The possibility of objectively selecting robot-assisted training items based on the severity of paralysis was simulated using the two-parameter logistic model item response theory (2PLM-IRT). Sample data were generated using the Monte Carlo method with 300 random cases. This simulation analyzed sample data (categorical data with three difficulty values of 0, 1, and 2 [0: too easy, 1: adequate, and 2: too difficult]) with 71 items per case. First, the most appropriate method was selected to ensure the local independence of the sample data necessary to use 2PLM-IRT. The method was to exclude items with low response probability (maximum response probability) within a pair in the Quality of Compensatory Movement Score (QCM) 1-point item difficulty curve, items with low item information content within a pair in the QCM 1-point item difficulty curve, and items with low item discrimination. Second, 300 cases were analyzed to determine the most appropriate model (one-parameter or two-parameter item response therapy) to be used and the most favored method to establish local independence. We also examined whether robotic training items could be selected according to the severity of paralysis based on the ability of a person (θ) in the sample data as calculated by 2PLM-IRT. Excluding items with low response probability (maximum response probability) in a pair in the categorical data 1-point item difficulty curve was effective in ensuring local independence. Additionally, to ensure local independence, the number of items should be reduced to 61 from 71, indicating that the 2PLM-IRT was an appropriate model. The ability of a person (θ) calculated by 2PLM-IRT suggested that seven training items could be estimated from 300 cases according to severity. This simulation made it possible to objectively estimate the training items according to the severity of paralysis in a sample of approximately 300 cases using this model.

Attempt to Make the Upper-Limb Item of Objective Fugl-Meyer Assessment Using 9-Axis Motion Sensors.

The Fugl-Meyer Assessment (FMA) has been used as a functional assessment of upper-limb function in stroke patients. This study aimed to create a more objective and standardized evaluation based on an FMA of the upper-limb items. A total of 30 first-ever stroke patients (65.3 ± 10.3 years old) and 15 healthy participants (35.4 ± 13.4 years old) admitted to Itami Kousei Neurosurgical Hospital were included. A nine-axis motion sensor was attached to the participants, and the joint angles of 17 upper-limb items (excluding fingers) and 23 FMA upper-limb items (excluding reflexes and fingers) were measured. From the measurement results, we analyzed the time-series data of each movement and obtained the correlation between the joint angles of each part. Discriminant analysis showed that 17 and 6 items had a concordance rate of ≥80% (80.0~95.6%) and <80% (64.4~75.6%), respectively. In the multiple regression analysis of continuous variables of FMA, a good regression model was obtained to predict the FMA with three to five joint angles. The discriminant analysis for 17 evaluation items suggests the possibility of roughly calculating FMA scores from joint angles.

Structural validity and internal consistency of a hypothesized factor structure of the Fugl-Meyer Assessment of the upper extremity.

BACKGROUND: Many studies have confirmed the psychometric properties of Fugl-Meyer Assessment of the upper extremity (FMA-UE). Although several modified versions of the FMA-UE form exist, their structural validity has not been fully established. OBJECTIVES: To assess the structural validity and internal consistency of the original, short, and hypothesized FMA-UE forms. METHODS: In this cross-sectional, multicenter, observational study, the factor structure was assessed using confirmatory factor analysis (CFA) to evaluate the adequate model of each hypothetical FMA-UE form (original, 30-item, 27-item, and 6-item forms). The internal consistency of each FMA-UE form and subscale was assessed using Cronbach's alpha after factor structure evaluation. RESULTS: We recruited 363 patients with first-episode stroke (median age = 70.0, median days = 75.0). The results of the original form models were not estimated by CFA. Of all FMA-UE forms, the 30-item form lacked three reflex items (4-factor, 30-item model) and the 27-item form lacked three reflex and three coordination items (3-factor, 27-item, second-order model); these forms demonstrated an adequate model fitness (root mean square error of approximation = 0.056/0.059, comparative fit index = 0.995/0.996, Tucker-Lewis index = 0.995/0.995). The 6-item form demonstrated a poor model fit. All FMA-UE forms and subscales showed a high internal consistency (Cronbach's alpha>0.91). CONCLUSIONS: Both 30- and 27-item FMA-UE forms showed a good factor structure; therefore, these forms are eligible for use in clinical practice. However, future studies should define the factor structure of the 6-item form.

Psychometric properties of the Action Research Arm Test using decision rules for skipping items in hemiparetic patients after stroke: a retrospective study.

PURPOSE: Important properties have been studied using the Action Research Arm Test (ARAT) in patients with stroke. However, whether the ARAT subtests constitute a Guttman scale (i.e., items hierarchically ordered according to difficulty) remains unclear. Guttman scales can define decision rules for skipping items in patients with low endurance. This study investigated the psychometric properties of the ARAT when applying decision rules for post-stroke hemiparetic patients. METHODS: A retrospective, single-institution study was conducted between 2020 and 2021. Datasets of 30 patients with stroke-induced hemiparesis were collected from a previous study which employed the ARAT without decision rules, Fugl-Meyer assessment (FMA), Box and Block Test (BBT), and Motor Activity Log (MAL). The ARAT was rescored with decision rules for this study, and inter-rater reliability/agreement, parallel forms reliability, and construct validity were assessed. RESULTS: Parallel forms reliability (Spearman's rho) was 0.99 (95% CI, 0.99-0.99) for both raters. The lower 95% CI limits of the sum and individual item scores in the reliability analysis exceeded the planned value (0.8). Construct validity values exceeded the planned value (0.8) for FMA, BBT, and MAL. CONCLUSION: Decision rules can be used to skip ARAT items when assessing upper extremity motor function in stroke patients.IMPLICATIONS FOR REHABILITATIONThe Action Research Arm Test with decision rules for skipping items was valid and reliable for measuring upper extremity motor function in hemiparetic patients after stroke.The decision rules may reduce the burden of both patients and evaluators by decreasing the number of Action Research Arm Test items to be administrated.

Factors associated with prognosis of upper limb function in branch atheromatous disease.

BACKGROUND: Branch atheromatous disease (BAD) is often associated with corticospinal tract injury, and some patients develop early neurological deterioration (END) in the acute phase. This study investigated the progress of upper limb prognosis after BAD in the acute phases and examined the factors related to the prognosis of upper limb function. PROCEDURES: 108 subjects diagnosed with BAD were included. Then subjects were classified into two groups: those with good recovery of upper limb function and those with poor recovery of upper limb function. Univariate and multivariate analyses were performed with the objective variable being good or poor upper limb function. The following factors were used as explanatory variables: age, the volume of infarction, initial Fugl-Meyer assessment (FMA) upper limb score, and presence of END. MAIN FINDINGS: The univariate analysis showed significant differences in age and volume of infarction (p < 0.05). Multivariate analysis showed the following finding: age;(OR 0.977,95%CI 0.917-0.997,p = 0.0061; volume of infarction;(OR 0.645,95%CI 0.461-0.902,p = 0.0104). A significant difference was found in the age and volume of the infarct. CONCLUSION: This study finding suggests that age and volume of infarction are associated with the prognosis of upper extremity paralysis in BAD.

Robot-Assisted Training as Self-Training for Upper-Limb Hemiplegia in Chronic Stroke: A Randomized Controlled Trial.

BACKGROUND: This study aimed to examine whether robotic self-training improved upper-extremity function versus conventional self-training in mild-to-moderate hemiplegic chronic stroke patients. METHODS: Study design was a multi-center, prospective, randomized, parallel-group study comparing three therapist-guided interventions (1-hour sessions, 3×/wk, 10 weeks). We identified 161 prospective patients with chronic, poststroke, upper-limb hemiplegia treated at participating rehabilitation centers. Patients were enrolled between November 29, 2016, and November 12, 2018 in Japan. A blinded web-based allocation system was used to randomly assign 129 qualifying patients into 3 groups: (1) conventional self-training plus conventional therapy (control, N=42); (2) robotic self-training (ReoGo-J) plus conventional therapy (robotic therapy [RT], N=44); or (3) robotic self-training plus constraint-induced movement therapy (N=43). PRIMARY OUTCOME: Fugl-Meyer Assessment for upper-extremity. SECONDARY OUTCOMES: Motor Activity Log-14 amount of use and quality of movement; Fugl-Meyer Assessment shoulder/elbow/forearm, wrist, finger, and coordination scores; Action Research Arm Test Score; Motricity Index; Modified Ashworth Scale; shoulder, elbow, forearm, wrist, and finger range of motion; and Stroke Impact Scale (the assessors were blinded). Safety outcomes were adverse events. RESULTS: Safety was assessed in 127 patients. An intention-to-treat full analysis set (N=121), and a per-protocol set (N=115) of patients who attended 80% of sessions were assessed. One severe adverse event was recorded, unrelated to the robotic device. No significant differences in Fugl-Meyer Assessment for upper-extremity scores were observed between groups (RT versus control: -1.04 [95% CI, -2.79 to 0.71], P=0.40; RT versus movement therapy: -0.33 [95% CI, -2.02 to 1.36], P=0.90). The RT in the per-protocol set improved significantly in the Fugl-Meyer Assessment for upper-extremity shoulder/elbow/forearm score (RT versus control: -1.46 [95% CI, -2.63 to -0.29]; P=0.037). CONCLUSIONS: Robotic self-training did not improve upper-limb function versus usual self-training, but may be effective combined with conventional therapy in some populations (per-protocol set). REGISTRATION: URL: https://www.umin.ac.jp/ctr; Unique identifier: UMIN000022509.

Impact of the robotic-assistance level on upper extremity function in stroke patients receiving adjunct robotic rehabilitation: sub-analysis of a randomized clinical trial.

BACKGROUND: Robotic therapy has been demonstrated to be effective in treating upper extremity (UE) paresis in stroke survivors. However, it remains unclear whether the level of assistance provided by robotics in UE training could affect the improvement in UE function in stroke survivors. We aimed to exploratorily investigate the impact of robotic assistance level and modes of adjustment on functional improvement in a stroke-affected UE. METHODS: We analyzed the data of 30 subacute stroke survivors with mild-to-severe UE hemiplegia who were randomly assigned to the robotic therapy (using ReoGo System) group in our previous randomized clinical trial. A cluster analysis based on the training results (the percentage of each stroke patient's five assistance modes of robotics used during the training) was performed. The patients were divided into two groups: high and low robotic assistance groups. Additionally, the two groups were sub-categorized into the following classes based on the severity of UE functional impairment: moderate-to-mild [Fugl-Meyer Assessment (FMA) score ≥ 30] and severe-to-moderate class (FMA < 30). The outcomes were assessed using FMA, FMA-proximal, performance-time in the Wolf motor function test (WMFT), and functional assessment scale (FAS) in WMFT. The outcomes of each class in the two groups were analyzed. A two-way analysis of variance (ANOVA) was conducted with robot assistance level and severity of UE function as explanatory factors and the change in each outcome pre- and post-intervention as the objective factor. RESULTS: Overall, significant differences of the group × severity interaction were found in most of the outcomes, including FMA-proximal (p = 0.038, η2 = 0.13), WMFT-PT (p = 0.021, η2 = 0.17), and WMFT-FAS (p = 0.045, η2 = 0.14). However, only the FMA score appeared not to be significantly different in each group (p = 0.103, η2 = 0.09). CONCLUSION: An optimal amount of robotic assistance is a key to maximize improvement in post-stroke UE paralysis. Furthermore, severity of UE paralysis is an important consideration when deciding the amount of assistance in robotic therapy. Trial registration Trial enrollment was done at UMIN (UMIN 000001619, registration date was January 1, 2009).

Psychometric properties of the TEMPA for the assessment of arm motor activity capacity in hemiparetic Japanese patients after stroke.

PURPOSE: To investigate the psychometric properties of the Test d'Evaluation des Membres Suprieurs de Personnes Agres (TEMPA) for the affected upper extremity in a population of Japanese patients with stroke. MATERIALS AND METHODS: A prospective, cross-sectional, single-center study involving 30 patients with stroke was conducted. The inter-rater reliability, the validity, and the internal consistency were assessed. The Fugl-Meyer Assessment (FMA), the Action Research Arm Test (ARAT), the Motor Activity Log, and the Box-and-Block Test were employed for assessing the validity. RESULTS: The English TEMPA instructions were successfully translated in accordance with the accepted principles of translation. The weighted Kappa coefficients for the functional rating scores were 0.87, 0.93, and 0.91 for combined total score, unilateral total score, and bilateral total scores. No statistically significant systematic disagreement was seen in the combined scores. The Spearman's rho values were higher than 0.70 regarding the gold standard tools (the FMA-UE motor domain and the ARAT). The Cronbach's alpha was 0.940 in the functional rating scale and 0.998 in the task analysis scale. CONCLUSIONS: The most aspects of the Japanese TEMPA showed acceptable levels of inter-rater reliability and validity in patients with affected upper extremities after stroke.IMPLICATIONS FOR REHABILITATIONThe TEMPA is reliable and valid in measuring activity capacity of upper extremity in patients with stroke.The functional rating score of the TEMPA is recommended to assess activities related to daily living, especially when users need to focus on bimanual activities.The TEMPA may help guide intervention that improve bimanual activity as well as the affected arm activity.

Dimensionality and item-difficulty hierarchy of the Fugl-Meyer assessment of the upper extremity among Japanese patients who have experienced stroke.

BACKGROUND: The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) has been used in many clinical studies and in stroke rehabilitation. In studies evaluating psychometric properties, confirmatory factor analysis (CFA) indicated that the FMA-UE is a multidimensional tool. Item Response Theory One-Parameter Logistic (IRT1PL) supports that item-difficulty hierarchy can be used as a treatment index of upper extremity function for stroke recovery. However, studies on the psychometric properties of the FMA-UE in Asian populations are lacking. OBJECTIVES: To investigate the dimensionality and item-difficulty hierarchy of the FMA-UE for stroke rehabilitation in Japanese patients. METHODS: This was a cross-sectional study. The participants comprised 268 individuals admitted for de novo stroke (median age, 70.0 years; median days since stroke onset, 78.5) in 22 hospitals in Japan. The dimensionality of the FMA-UE was evaluated using CFA of selected items. The item-difficulty hierarchy of the FMA-UE using the appropriately selected model was demonstrated using IRT1PL analysis after confirming dimensionality. RESULTS: Two reflex items were removed by utilizing the floor and ceiling effects. The 31- and 30-item FMA-UE exhibited a good model fit of the unidimensionality in the CFA. The 30-item FMA-UE was found to be a good model by model comparison (the 31-item vs. the 30-item). The item-difficulty hierarchy of the 30-item FMA-UE was found not to be consistent with the expected item order. CONCLUSIONS: This study provides evidence that the FMA-UE has multidimensionality and the 30-item FMA-UE is a valid instrument for measuring upper-extremity impairment after stroke.

Effects of mechanical thrombectomy for post-stroke patients with upper limb hemiparesis: Use of Propensity Score Matching.

BACKGROUND: Mechanical Thrombectomy (MT) is a recommended approach for post-cerebral ischemia in acute settings. Although a large amount of evidence suggests the use of MT, existing evidence has primarily focused on assessing lower limb performance or gait performance as an outcome measure. METHODS: This study was to investigate whether MT would be an effective approach for improving upper limb performance in post-stroke patients.This case control was divided into two groups: 154 patients as a control group only given conventional rehabilitation; and 25 patients as an intervention group given MT and conventional rehabilitation. Outcome variables were measured by calculating the change of Fugl-Meyer Assessment score at the last intervention compared with the beginning of the intervention. RESULT: By comparing the FMA scores after, the propensity matching compared between before receiving therapy intervention and after, the intervention group showed as follows: 30.4 ± 26.4-44.3 ± 25.4, p = 0.0019, r = 0.59. The control group showed as follows: 39.9 ± 24.1-49.1 ± 21.3, p = 0.002, r = 0.69. Lastly, a comparison of the intervention group with the control group about their FMA score change indicates as follows: intervention group: 13.9 ± 19.4, control group 9.2 ± 10.0, p = 0.2967, r = 0.15. CONCLUSION: This study indicated that there was no significant difference between MT and a conventional approach for improving UE function. However, this is the first study to investigate the course of recovery of UE function in the acute phase after MT, and this finding supports the need for further research.

Impact of initial flexor synergy pattern scores on improving upper extremity function in stroke patients treated with adjunct robotic rehabilitation: A randomized clinical trial.

Background: Robot-assisted rehabilitation is an appealing strategy for patients after stroke, as it generates repetitive movements in a consistent, precise, and automated manner. Objective: To identify patients who will benefit most from robotic rehabilitation for upper extremity (UE) hemiparesis. Methods:We used data from our previous randomized clinical trial comparing 6 weeks of robotic therapy (ReoGeo system) plus standard therapy (n=30) with self-guided therapy plus standard therapy (n=26) for sub-acute phase rehabilitation in adults with mild to moderate UE hemiparesis. The outcome measures were three Fugl-Meyer (FMA) motor scores: total UE score, proximal UE score, and UE flexor synergy score. Based on pre-therapy UE flexor synergy scores, participants were categorized into mild (10-12 points), moderate (6-9 points), and severe (0-5 points) impairment classes. Results: In the robotic group, all outcome measures improved after therapy in patients with moderate or severe impairment. In the self-guided therapy, most outcomes did not improve, regardless of the impairment class. When changes from pre- to post-therapy were compared between robotic and self-guided groups, most outcomes were similar in all impairment classes. However, robotic therapy was associated with greater improvement in UE flexor synergy than self-guided therapy in patients with moderate impairment (2.3±1.3 vs. -0.1±2.8, P=0.027). Conclusions: Post-strokerobot-assisted rehabilitation, as an adjunct to standard rehabilitation therapy, improved UE function in patients with moderate or severe pre-therapy UE flexor synergy impairment. Adjunct robotic therapy produced greater improvement in UE flexor synergy motor function than adjunct self-guided rehabilitation in patients with moderate pre-therapy impairment.

Clinimetric properties of the action research arm test for the assessment of arm activity in hemiparetic patients after stroke.

Background: The Action Research Arm Test (ARAT) has been extensively used for patients with stroke in many countries. However, the ARAT has been reported to have ceiling effects. Employing a time evaluation system could be expected to improve the ceiling effects in the ARAT.Objective: To investigate (1) the psychometric properties of the Japanese version of the ARAT in patients with stroke; (2) the psychometric properties of the performance timescale of the ARAT in patients with stroke.Methods: A prospective, cross-sectional, single-center study involving 30 patients with mild-to-severe hemiparesis was conducted. All patients were recruited from the college hospital in Japan from June 2016 to March 2017. The ARAT and the Fugl-Meyer Assessment, the Box-and-Block Test, and the Motor Activity Log were employed. The simultaneous/non-simultaneous inter-rater reliability/agreement, the internal consistency, the validity, and the floor/ceiling effects were assessed.Results: Regarding the ARAT score, intraclass correlation coefficient (ICC) ranged from 0.974 to 0.990 (P < 0.001) for non-simultaneous evaluation; and from 0.994 to 0.998 (P < 0.001) for simultaneous evaluation. Regarding the ARAT time, ICC was 0.992 (P < 0.001) for non-simultaneous evaluation; and 1.000 (P < 0.001) for simultaneous evaluation.Conclusions: The Japanese version of the ARAT is highly reliable and valid for measuring upper-extremity function in patients with stroke. Adding the performance timescale on the ARAT score scale can partially solve the "ceiling effect problem".

Clinimetric properties of the shortened Fugl-Meyer Assessment for the assessment of arm motor function in hemiparetic patients after stroke.

Background: The Fugl-Meyer Assessment (FMA) is widely used as the gold standard in stroke research. However, the FMA has not been used in general clinical practice, which may be related to the fact that the FMA is a time-consuming measurement. Therefore, the FMA (upper extremity motor section) has already been shortened to a 6-item version using Rasch analysis for routine assessments of patients with low endurance. Although the shortened FMA has already demonstrated sound clinical utility, data on its psychometric properties remain insufficient.Objective: This study aimed to investigate the psychometric properties of the shortened FMA for the affected upper extremity in patients following stroke.Methods: A retrospective single-center study involving 30 patients was conducted. This study was registered in 2018 as a pre-initiation condition. The data used in this study were obtained from a study conducted between 2016 and 2017. The FMA (33- and 6-item versions) and the Action Research Arm Test, the Box-and-Block Test, and the Motor Activity Log were employed, and inter-rater reliability/agreement, validity, and internal consistency were assessed.Results: Regarding inter-rater reliability, the intraclass correlation coefficient was 0.994 (95% confidence interval: 0.988-0.997; P < .001). The mean differences between the raters of the shortened FMA were 0.07, and the limits of agreement were calculated to be between -0.81 and 0.95. Regarding the motor-related measurements, Spearman's rho were all higher than 0.91. On the other hand, regarding the sensation and joint motion/pain domain, Spearman's rho ranged from 0.25 to 0.50, and Cronbach's alpha was 0.92.Conclusions: The shortened FMA can reliably assess the affected upper extremity in patients with hemiparesis after stroke.

Assessment of the Efficacy of ReoGo-J Robotic Training Against Other Rehabilitation Therapies for Upper-Limb Hemiplegia After Stroke: Protocol for a Randomized Controlled Trial.

Background: Stroke patients experience chronic hemiparesis in their upper extremities leaving negative effects on quality of life. Robotic therapy is one method to recover arm function, but its research is still in its infancy. Research questions of this study is to investigate how to maximize the benefit of robotic therapy using ReoGo-J for arm hemiplegia in chronic stroke patients. Methods: Design of this study is a multi-center parallel group trial following the prospective, randomized, open-label, blinded endpoint (PROBE) study model. Participants and setting will be 120 chronic stroke patients (over 6 months post-stroke) will be randomly allocated to three different rehabilitation protocols. In this study, the control group will receive 20 min of standard rehabilitation (conventional occupational therapy) and 40 min of self-training (i.e., sanding, placing and stretching). The robotic therapy group will receive 20 min of standard rehabilitation and 40 min of robotic therapy using ReoGo®-J device. The combined therapy group will receive 40 min of robotic therapy and 20 min of constraint-induced movement therapy (protocol to improve upper-limb use in ADL suggests). This study employs the Fugl-Meyer Assessment upper-limb score (primary outcome), other arm function measures and the Stroke Impact Scale score will be measured at baseline, 5 and 10 weeks of the treatment phase. In analysis of this study, we use the mixed effects model for repeated measures to compare changes in outcomes between groups at 5 and 10 Weeks. The registration number of this study is UMIN000022509. Conclusions: This study is a feasible, multi-site randomized controlled trial to examine our hypothesis that combined training protocol could maximize the benefit of robotic therapy and best effective therapeutic strategy for patients with upper-limb hemiparesis.

Reliability of remote evaluation for the Fugl-Meyer assessment and the action research arm test in hemiparetic patients after stroke.

Background Blinding for outcome assessors is considered less possible in rehabilitation treatment trials than in pharmacologic trials. This problem can be solved in part by the standardized remote evaluation system, in which researchers video-record patients for centralized assessment using prospectively standardized shooting procedures, and then outside assessors evaluate the videos using prospectively standardized methods. Objective To assess the inter-rater reliability of remote evaluation for the Fugl-Meyer assessment (FMA) and the action research arm test (ARAT) in hemiparetic patients after stroke. Methods A prospective, cross-sectional, single-center study involving 30 patients with mild-to-severe hemiparesis was conducted (Clinical Trial Registration-URL: http://www.umin.ac.jp/ . Unique identifier: UMIN000022192). Two assessments (direct observation and video observation) were performed for each participant by trained assessors. The direct observation assessment was video-recorded for the video observation assessment. In the current study, a standardized guidebook for test administration and scoring was used, along with prospectively standardized shooting procedures. Results Regarding the sum scores of the total/subtests of the FMA and ARAT, the intraclass correlation coefficient ranged from 0.992 to 0.998 (95% confidence interval [CI], 0.960-0.999; p < 0.0001) and Spearman's rho ranged from 0.949 to 1.000 (95% CI, 0.985-1.000; p < 0.0001). Regarding the individual item scores of the outcome measures, weighted kappa (median of the sum scores of total/subtests) ranged from 0.921 to 1.000. Conclusions Remote evaluation of the FMA and ARAT reliably assesses the affected upper extremities in patients with mild-to-severe hemiparesis after stroke.

Clinimetric properties of the Fugl-Meyer assessment with adapted guidelines for the assessment of arm function in hemiparetic patients after stroke.

BACKGROUND: Against the background of linguistic and cultural differences, there is a need for translation and adaptation from the English version of the Fugl-Meyer Assessment (FMA) to Japanese. In addition, there is no study of inter-rater reliability of FMA all domains for affected upper extremities with appropriate sample size based on the intraclass correlation coefficient (ICC) focusing on non-simultaneous assessment. OBJECTIVE: This study aimed (1) to translate the English version of the FMA and its administration/scoring manual; and (2) to investigate the psychometric properties of the Japanese version of the FMA in patients with stroke. METHODS: A prospective single-center study involving 30 patients was conducted. The FMA and the Action Research Arm Test, the Box-and-Block Test, and the Motor Activity Log were employed. The inter-rater/intra-rater reliability, the internal consistency, the validity, and the floor/ceiling effects were assessed. RESULTS: Regarding the non-simultaneous and simultaneous inter-rater reliability, ICC ranged from 0.809-0.983 (P<0.001) and 0.991-0.999 (P<0.001), respectively. Regarding the simultaneous intra-rater reliability, ICC ranged from 0.994-0.999 (P<0.001). The Cronbach's alpha was 0.973 in the non-simultaneous evaluation and 0.981 in the simultaneous evaluation. Regarding the validity, Spearman's rhos were higher than 0.92 for the FMA all domains and motor domain. The patients who showed the highest score and the lowest score of the FMA (all domains and motor domain) were 10% and 0%, respectively. CONCLUSIONS: The Japanese version of the FMA motor domain and all domains can reliably assess the affected upper extremities in patients with mild-to-severe hemiparesis after stroke for both non-simultaneous and simultaneous assessment.