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).

A scoping review of cognitive assessment tools and domains for chemotherapy-induced cognitive impairments in cancer survivors.

Backgrounds: Cancer survivors suffer from specific symptoms known as chemotherapy-induced cognitive impairments (CICIs). CICIs are difficult to capture with existing assessments such as the brief screening test for dementia. Although recommended neuropsychological tests (NPTs) exist, international consensus and shared cognitive domains of assessment tools are unknown. The aim of this scoping review was as follows: (1) to identify studies that assess CICIs in cancer survivors; (2) to identify shared cognitive assessment tools and domains by mapping the domains reported in studies using the International Classification of Functioning, Disability and Health (ICF) framework. Methods: The study followed the recommendations made by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. We searched the following three databases through October 2021: PubMed, CINAHL, and Web of Science. Prospective longitudinal or cross-sectional studies were selected to determine CICI-specific assessment tools for adult cancer survivors. Results: Sixty-four prospective studies (36 longitudinal studies and 28 cross-sectional studies) were included after checking for eligibility. The NPTs were divided into seven main cognitive domains. The specific mental functions were often used in the order of memory, attention, higher-level cognitive functions, and psychomotor functions. Perceptual functions were used less frequently. In some ICF domains, shared NPTs were not clearly identified. In some different domains, the same NPTs were used, such as the trail making test and the verbal fluency test. When the association between the publishing year and the amount of NPT use was examined, it was found that the amount of tool use tended to decline over the publication years. The Functional Assessment of Cancer Therapy-Cognitive function (FACT-Cog) was a shared consensus tool among the patient-reported outcomes (PROs). Conclusion: Chemotherapy-induced cognitive impairments are currently gaining interest. Shared ICF domains such as memory and attention were identified for NPTs. There was a gap between the publicly recommended tools and the tools actually used in the studies. For PROs, a clearly shared tool, FACT-Cog, was identified. Mapping the domains reported in studies using the ICF can help in the process of reviewing consensus on which NPTs may be used to target cognitive domains. Systematic review registration: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000053710, identifier UMIN000047104.

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.

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.

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.

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.

A one-year follow-up after modified constraint-induced movement therapy for chronic stroke patients with paretic arm: a prospective case series study.

BACKGROUND: Despite the confirmed short-term effects of constraint-induced movement therapy, the long-term effects have not been sufficiently verified in terms of functional improvement of the affected arm. OBJECTIVE: To evaluate the long-term effects and relationship between arm use in activities of daily living and arm improvement with modified constraint-induced movement therapy in chronic stroke patients. METHODS: At 1 year after completing modified constraint-induced movement therapy, arm function (Fugl-Meyer Assessment) and amount of daily arm use (motor activity log) were assessed. RESULTS: Fourteen post-stroke patients with mild to moderate impairment of arm function were analyzed. One year after completing modified constraint-induced movement therapy, participants consistently showed improvements in arm function and amount of daily arm use (analysis of variance: Fugl-Meyer Assessment, P < 0.001; Motor Activity Log, P < 0.001). For the Fugl-Meyer Assessment, post-hoc tests detected significant improvements (pre versus post, P = 0.009; pre versus 1 year, P < 0.0001; post versus 1 year, P < 0.036). For the Motor Activity Log, post-hoc tests also detected significant improvements (pre versus post, P = 0.0001; pre versus 1 year, P < 0.0001; post versus 1 year, P = 0.0014). The magnitude of the change in Fugl-Meyer Assessment score correlated significantly with the change in Motor Activity Log score (R = 0.778, P = 0.001). CONCLUSIONS: Among post-stroke patients with mild to moderate impairments of arm function, modified constraint-induced movement therapy without any other rehabilitation after intervention may improve arm function and increase arm use for 1 year. In addition, increasing arm use may represent an important factor in improving arm function, and vice versa.

Constraint-Induced Movement Therapy After Injection of Botulinum Toxin Type A for a Patient With Chronic Stroke: One-Year Follow-up Case Report.

BACKGROUND AND PURPOSE: Spasticity, an aspect of upper motor neuron syndrome, is a widespread problem in patients with stroke. To date, no study has reported the long-term (up to 1 year) outcomes of botulinum toxin (BTX) injection in combination with constraint-induced movement therapy in patients with chronic stroke. In this case report, the long-term (1 year) effects of the combination of BTX type A injection and constraint-induced movement therapy on spasticity and arm function in a patient with chronic stroke and arm paresis are described. CASE DESCRIPTION: The patient was a 66-year-old man who had had an infarction in the right posterior limb of the internal capsule 4 years before the intervention. At screening, the patient was not able to voluntarily extend his interphalangeal or metacarpophalangeal joints beyond the 10 degrees required for constraint-induced movement therapy. From 12 days after BTX type A injection, the patient received 5 hours of constraint-induced movement therapy for 10 weekdays. OUTCOMES: All outcome measures (Modified Ashworth Scale, Fugl-Meyer Assessment, Action Research Arm Test, and amount of use scale of the Motor Activity Log) improved substantially over the 1-year period (before intervention to 1 year after intervention). Repeat BTX type A injections were not necessary because muscle tone and arm function did not worsen during the observation period. DISCUSSION: The improved arm function may have reflected improvements in volitional movements and coordination or speed of movements in the paretic arm as a result of a reduction in spasticity, a reduction of learned nonuse behaviors, or use-dependent plasticity after the combination of BTX type A injection and constraint-induced movement therapy. In addition, the possibility of an influence of the passage of time or the Hawthorne effect cannot be ruled out. If this approach proves useful in future controlled studies, it may reduce the rising medical costs of the treatment of stroke.

Therapeutic synergism in the treatment of post-stroke arm paresis utilizing botulinum toxin, robotic therapy, and constraint-induced movement therapy.

Botulinum toxin type A (BtxA) injection, constraint-induced movement therapy (CIMT), and robotic therapy (RT) each represent promising approaches to enhance arm motor recovery after stroke. To provide more effective treatment for a 50-year-old man with severe left spastic hemiparesis, we attempted to facilitate CIMT with adaptive approaches to extend the wrist and fingers using RT for 10 consecutive weeks after BtxA injection. This combined treatment resulted in substantial improvements in arm function and the amount of arm use in activities of daily living, and may be effective for stroke patients with severe arm paresis. However, we were unable to sufficiently prove the efficacy of combined treatment based only on a single case. To fully elucidate the efficacy of the combined approach for patients with severe hemiparesis after stroke, future studies of a larger number of patients are needed.

A 6-month follow-up after constraint-induced movement therapy with and without transfer package for patients with hemiparesis after stroke: a pilot quasi-randomized controlled trial.

OBJECTIVE: To investigate the long-term effects of the 'transfer package' in constraint-induced movement therapy, which is an optional protocol to facilitate actual use of the trained affected arm in activities of daily living. DESIGN: A pilot quasi-randomized controlled trial with a blinded single assessor with six-month follow-up. SETTING: Hospitalized care at university hospital. SUBJECTS: Twenty-one post-stroke patients were quasi-randomized to either a group with transfer package during constraint-induced movement therapy or a control group (without transfer package). INTERVENTIONS: The transfer package group received 4.5 hours of intensive task training and 0.5 hours of transfer package whereas the control group received 5.0 hours of intensive task training per day during 10 consecutive weekdays. MAIN MEASURES: Arm function was measured with Fugl-Meyer Assessment and Amount of Use score of Motor Activity Log. RESULTS: Twenty-three patients were quasi-randomized, but data from two patients were missing from the long-term follow-up. Both groups showed increase in arm function postintervention. However, at six months' follow-up only the transfer package group showed consistent increase in arm function (with transfer package group versus control group; Fugl-Meyer Assessment, mean (± SD) from 48.6 ± 7.8 (preintervention) to 55.7 ± 4.5 (postintervention) and 59.0 ± 3.6 (six months postintervention) versus from 49.1 ± 5.5 to 52.8 ± 6.0 and 53.3 ± 4.9, P= 0.003; Amount of Use scale of Motor Activity Log, mean from 1.3 ± 0.55 (preintervention) to 2.12 ± 0.55 (postintervention) and 2.79 ± 0.98 (six months postintervention) versus from 1.18 ± 0.70 to 1.61 ± 0.54 and 1.65 ± 0.68, P= 0.002). CONCLUSIONS: Our results confirmed the long-term effects of the transfer package in constraint-induced movement therapy.