Inaccurate Use of the Upper Extremity Fugl-Meyer Negatively Affects Upper Extremity Rehabilitation Trial Design: Findings From the ICARE Randomized Controlled Trial.
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ABSTRACT: Objective
To determine the extent to which estimates of sample and effect size in stroke rehabilitation trials can be affected by simple summation of ordinal Upper Extremity Fugl-Meyer (UEFM) items compared with a Rasch-rescaled UEFM.Design
Rasch analysis of Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) phase III trial data, comparing 3 upper extremity (UE) motor treatments in stroke survivors enrolled 45.8±22.4 days poststroke. Participants underwent a structured UE motor training known as the Accelerated Skill Acquisition Program, usual and customary care, or dose-equivalent care. UEFM data from baseline, postintervention, and 6 and 12 months later were included for analysis.Setting
Outpatient stroke rehabilitation.Participants
ICARE participants (N=361).Interventions
Not applicable.Main outcome measures
Item difficulties, person abilities, and sample size.Results
Because of their ordinality, summed raw UEFM scores measured motor impairment inconsistently across different ranges of stroke severity relative to the rescaled UEFM. In the full ICARE sample, raw UEFM understated scores relative to the rescaled UEFM by 7.4 points for the most severely impaired, but overstated scores by up to 8.4 points toward the ceiling. As a result, 50.9% of all UEFM observations showed a residual error greater than 10% of the total UEFM score. Relative to the raw scores, the rescaled UEFM improved the effect size of change in motor impairment between baseline and 1 year (d=0.35). For a hypothetical 3-arm trial resembling ICARE, UEFM rescaling reduced the required sample size by 32% (n=108) compared with raw UEFM (n=159).Conclusions
In UE rehabilitation trials, a rescaled UEFM potentially decreases sample size by one-third, decreasing costs, duration, and the number of subjects exposed to experimental risks. This benefit is obtained through increased measurement efficiency. Reductions in ceiling effects are also possible. These findings apply to ICARE-like trials. Confirmatory validation in another phase III trial is needed.
SUBMITTER: Geed S
PROVIDER: S-EPMC7854957 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and objectives: The Upper Extremity Fugl-Meyer Assessment (UEFMA) is one of the most recommended and used methods of clinical evaluation not only for post-stroke motor function disability conditions but also for physiotherapy goal-setting. Up to the present, an official Romanian version has not been officially available. This study aims to carry out a translation, adaptation, and validation of UEFMA in Romanian, thus giving both patients and medical practitioners the equal opportunity of benefiting from its proficiency. Material and methods: The English version of the motor component of UEFMA was back and forth translated in the assent of best practice translation guidelines. The research was performed on a group of 64 post-stroke in-patients regarding psychometric properties for content validation and an exploratory and confirmatory factorial analysis was performed using the Bayesian model. To assess internal consistency and test-retest reliability, we used the Cronbach Alpha index and Intraclass Correlation Coefficient (ICC). We used Pearson correlation with the Functional Independence Measure (FIM) and Modified Rankin Scale (MRS) to determine concurrent validation. Standardized response mean (SRM) was applied to determine the responsiveness of the instrument used. Results: After performing the exploratory factor analysis, a single factor was extracted, with an Eigenvalue of 19.363, which explained 64.543% of the variation. The model was confirmed by Bayesian exploration, with Root Mean Square Residual (RMR) 0.051, Goodness-of-fit Index (GFI) 0.980, Normed-Fit Index (NFI) 0.978 and Relative Fit Index (RFI) 0.977. The Cronbach Alpha value was 0.981, the Intraclass Correlation Coefficient (ICC) index for average measures was 0.992, the Pearson correlation with FIM 0.789, and MRS -0.787, while the SRM was 1.117. Conclusions: The Romanian version of the UEFMA scale is a reliable, responsive and valid tool which can be used as a standardized assessment in post-stroke patients across Romania.
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Project description:Virtual home-based rehabilitation is an emerging area in stroke rehabilitation. Functional assessment tools are essential to monitor recovery and provide current function-based rehabilitation. We developed the Fugl-Meyer Assessment (FMA) tool using Kinect (Microsoft, USA) and validated it for hemiplegic stroke patients. Forty-one patients with hemiplegic stroke were enrolled. Thirteen of 33 items were selected for upper extremity motor FMA. One occupational therapist assessed the motor FMA while recording upper extremity motion with Kinect. FMA score was calculated using principal component analysis and artificial neural network learning from the saved motion data. The degree of jerky motion was also transformed to jerky scores. Prediction accuracy for each of the 13 items and correlations between real FMA scores and scores using Kinect were analyzed. Prediction accuracies ranged from 65% to 87% in each item and exceeded 70% for 9 items. Correlations were high for the summed score for the 13 items between real FMA scores and scores obtained using Kinect (Pearson's correlation coefficient = 0.873, P<0.0001) and those between total upper extremity scores (66 in full score) and scores using Kinect (26 in full score) (Pearson's correlation coefficient = 0.799, P<0.0001). Log transformed jerky scores were significantly higher in the hemiplegic side (1.81 ± 0.76) compared to non-hemiplegic side (1.21 ± 0.43) and showed significant negative correlations with Brunnstrom stage (3 to 6; Spearman correlation coefficient = -0.387, P = 0.046). FMA using Kinect is a valid way to assess upper extremity function and can provide additional results for movement quality in stroke patients. This may be useful in the setting of unsupervised home-based rehabilitation.
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Project description: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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Project description:ImportanceClinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits.ObjectiveTo compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation.Design, setting, and participantsPhase 3, pragmatic, single-blind randomized trial among 361 participants with moderate motor impairment recruited from 7 US hospitals over 44 months, treated in the outpatient setting from June 2009 to March 2014.InterventionsStructured, task-oriented upper extremity training (Accelerated Skill Acquisition Program [ASAP]; n = 119); dose-equivalent occupational therapy (DEUCC; n = 120); or monitoring-only occupational therapy (UCC; n = 122). The DEUCC group was prescribed 30 one-hour sessions over 10 weeks; the UCC group was only monitored, without specification of dose.Main outcomes and measuresThe primary outcome was 12-month change in log-transformed Wolf Motor Function Test time score (WMFT, consisting of a mean of 15 timed arm movements and hand dexterity tasks). Secondary outcomes were change in WMFT time score (minimal clinically important difference [MCID] = 19 seconds) and proportion of patients improving ≥25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points).ResultsAmong the 361 randomized patients (mean age, 60.7 years; 56% men; 42% African American; mean time since stroke onset, 46 days), 304 (84%) completed the 12-month primary outcome assessment; in intention-to-treat analysis, mean group change scores (log WMFT, baseline to 12 months) were, for the ASAP group, 2.2 to 1.4 (difference, 0.82); DEUCC group, 2.0 to 1.2 (difference, 0.84); and UCC group, 2.1 to 1.4 (difference, 0.75), with no significant between-group differences (ASAP vs DEUCC: 0.14; 95% CI, -0.05 to 0.33; P = .16; ASAP vs UCC: -0.01; 95% CI, -0.22 to 0.21; P = .94; and DEUCC vs UCC: -0.14; 95% CI, -0.32 to 0.05; P = .15). Secondary outcomes for the ASAP group were WMFT change score, -8.8 seconds, and improved SIS, 73%; DEUCC group, WMFT, -8.1 seconds, and SIS, 72%; and UCC group, WMFT, -7.2 seconds, and SIS, 69%, with no significant pairwise between-group differences (ASAP vs DEUCC: WMFT, 1.8 seconds; 95% CI, -0.8 to 4.5 seconds; P = .18; improved SIS, 1%; 95% CI, -12% to 13%; P = .54; ASAP vs UCC: WMFT, -0.6 seconds, 95% CI, -3.8 to 2.6 seconds; P = .72; improved SIS, 4%; 95% CI, -9% to 16%; P = .48; and DEUCC vs UCC: WMFT, -2.1 seconds; 95% CI, -4.5 to 0.3 seconds; P = .08; improved SIS, 3%; 95% CI, -9% to 15%; P = .22). A total of 168 serious adverse events occurred in 109 participants, resulting in 8 patients withdrawing from the study.Conclusions and relevanceAmong patients with motor stroke and primarily moderate upper extremity impairment, use of a structured, task-oriented rehabilitation program did not significantly improve motor function or recovery beyond either an equivalent or a lower dose of UCC upper extremity rehabilitation. These findings do not support superiority of this program among patients with motor stroke and primarily moderate upper extremity impairment.Trial registrationclinicaltrials.gov Identifier: NCT00871715.
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Project description:BackgroundThe majority of stroke survivors experience motor impairment which benefits from rehabilitation treatment. Telerehabilitation, remote delivery of rehabilitation services, is a possible solution providing access to rehabilitation for stroke survivors living in rural areas or in situations like the COVID-19 pandemic where face-to-face treatment may be risky. However, valid and reliable motor impairment measures have not yet been established over a telerehabilitation platform. The Fugl-Meyer (FM) lower extremity assessment is widely used clinically and in research. Thus, the aim was to develop a modified FM for telerehabilitation (FM-tele) and assess the feasibility and preliminary agreement of FM-tele scores with the FM.MethodsThree phases were employed: phase 1 development, phase 2 feasibility, and phase 3 preliminary agreement. Literature review and consultation with clinicians were employed to develop the FM-tele. Community-dwelling individuals with stroke and FM evaluators were consulted to provide feedback via questionnaires on the feasibility of the FM-tele. To assess the preliminary agreement of the FM-tele, individuals with stroke participated in two sessions, one in-person and one via telerehabilitation. The standard version of the FM was administered during the in-person session. The FM-tele was administered in both sessions.ResultsFrom phase 1, clinician consultation identified the following key principles: safety of the client, clear lower extremity visualization, and minimization of position changes which guided FM-tele development (n = 7). Feasibility was established in phase 2 where participants with stroke indicated that they felt safe and experienced ease following the standardized instructions, despite some technological concerns (n = 5). FM evaluators agreed that participants were safe and indicated effective standardized instructions. Phase 3 (n = 5) indicated preliminary agreement of the FM-tele compared with the FM.ConclusionsParticipants with stroke and clinical consultation indicated the FM-tele developed for telerehabilitation is feasible. A lower extremity motor assessment tool for telerehabilitation is urgently needed for stroke survivors living in rural areas or when face-to-face visits are impossible. This pilot study provides preliminary support for a future study.
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Project description:BackgroundExergames are increasingly being used among survivors of stroke with chronic upper extremity (UE) sequelae to continue exercising at home after discharge and maintain activity levels. The use of virtual reality exergames combined with a telerehabilitation app (VirTele) may be an interesting alternative to rehabilitate the UE sequelae in survivors of chronic stroke while allowing for ongoing monitoring with a clinician.ObjectiveThis study aimed to determine the feasibility of using VirTele in survivors of chronic stroke at home and explore the impact of VirTele on UE motor function, quantity and quality of use, quality of life, and motivation in survivors of chronic stroke compared with conventional therapy.MethodsThis study was a 2-arm feasibility clinical trial. Eligible participants were randomly allocated to an experimental group (receiving VirTele for 8 weeks) or a control group (receiving conventional therapy for 8 weeks). Feasibility was measured from the exergame and intervention logs completed by the clinician. Outcome measurements included the Fugl-Meyer Assessment-UE, Motor Activity Log-30, Stroke Impact Scale-16, and Treatment Self-Regulation Questionnaire-15, which were administered to both groups at four time points: time point 1 (T1; before starting the intervention), time point 2 (after the intervention), time point 3 (1 month after the intervention), and time point 4 (T4; 2 months after the intervention).ResultsA total of 11 survivors of stroke were randomized and allocated to an experimental or a control group. At the onset of the COVID-19 pandemic, participants pursued the allocated treatment for 3 months instead of 8 weeks. VirTele intervention dose was captured in terms of time spent on exergames, frequency of use of exergames, total number of successful repetitions, and frequency of videoconference sessions. Technical issues included the loss of passwords, internet issues, updates of the system, and problems with the avatar. Overall, most survivors of stroke found the technology easy to use and useful, except for 9% (1/11) of participants. For the Fugl-Meyer Assessment-UE and Motor Activity Log-30, both groups exhibited an improvement in >50% of the participants, which was maintained over time (from time point 3 to T4). Regarding Stroke Impact Scale-16 scores, the control group reported improvement in activities of daily life (3/5, 60%), hand function (5/5, 100%), and mobility (2/5, 40%), whereas the experimental group reported varied and inconclusive results (from T1 to T4). For the Treatment Self-Regulation Questionnaire-15, 75% (3/4) of the experimental group demonstrated an increase in the autonomous motivation score (from T1 to time point 2), whereas, in the control group, this improvement was observed in only 9% (1/11) of participants.ConclusionsThe VirTele intervention constitutes another therapeutic alternative, in addition to conventional therapy, to deliver an intense personalized rehabilitation program for survivors of chronic stroke with UE sequelae.International registered report identifier (irrid)RR2-10.2196/14629.
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Project description:Robotic rehabilitation is a promising approach to treat individuals with neurological or orthopedic disorders. However, despite significant advancements in the field of rehabilitation robotics, this technology has found limited traction in clinical practice. A key reason for this issue is that most robots are expensive, bulky, and not scalable for in-home rehabilitation. Here, we introduce a semi-passive rehabilitation robot (SepaRRo) that uses controllable passive actuators (i.e., brakes) to provide controllable resistances at the end-effector over a large workspace in a manner that is cost-effective and safe for in-home use. We also validated the device through theoretical analyses, hardware experiments, and human subject experiments. We found that by including kinematic redundancies in the robot's linkages, the device was able to provide controllable resistances to purely resist the movement of the end-effector, or to gently steer (i.e., perturb) its motion away from the intended path. When testing these capabilities on human subjects, we found that many of the upper-extremity muscles could be selectively targeted based on the forcefield prescribed to the user. These results indicate that SepaRRo could serve as a low-cost therapeutic tool for upper-extremity rehabilitation; however, further testing is required to evaluate its therapeutic benefits in patient population.
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Project description:Immersive and non-immersive virtual reality (NIVR) technology can supplement and improve standard physiotherapy and neurorehabilitation in post-stroke patients. We aimed to use MIRA software to investigate the efficiency of specific NIVR therapy as a standalone intervention, versus standardized physiotherapy for upper extremity rehabilitation in patients post-stroke. Fifty-five inpatients were randomized to control groups (applying standard physiotherapy and dexterity exercises) and experimental groups (applying NIVR and dexterity exercises). The two groups were subdivided into subacute (<six months post-stroke) and chronic (>six months to four years post-stroke survival patients). The following standardized tests were applied at baseline and after two weeks post-therapy: Fugl-Meyer Assessment for Upper Extremity (FMUE), the Modified Rankin Scale (MRS), Functional Independence Measure (FIM), Active Range of Motion (AROM), Manual Muscle Testing (MMT), Modified Ashworth Scale (MAS), and Functional Reach Test (FRT). The Kruskal-Wallis test was used to determine if there were significant differences between the groups, followed with pairwise comparisons. The Wilcoxon Signed-Rank test was used to determine the significance of pre to post-therapy changes. The Wilcoxon Signed-Rank test showed significant differences in all four groups regarding MMT, FMUE, and FIM assessments pre- and post-therapy, while for AROM, only experimental groups registered significant differences. Independent Kruskal-Wallis results showed that the subacute experimental group outcomes were statistically significant regarding the assessments, especially in comparison with the control groups. The results suggest that NIVR rehabilitation is efficient to be administered to post-stroke patients, and the study design can be used for a further trial, in the perspective that NIVR therapy can be more efficient than standard physiotherapy within the first six months post-stroke.
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Project description:Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.www.ClinicalTrials.gov Identifier: NCT00871715
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Project description:BACKGROUND Both spinal cord stimulators (SCS) and interdisciplinary chronic pain rehabilitation program (CPRP) are evidence-based treatments for chronic pain but differ on treatment foci. SCS focuses on decreasing the subjective pain experience as a means of improving function and quality of life. CPRP focuses on addressing the cognitive, emotional, and behavioral factors associated with chronic pain to improve function. Due to experimental constraints, these 2 treatment options are difficult to compare; however, this case report offers a unique opportunity to examine outcomes for both interventions in a sequential manner for changes in pain, function, and mood. CASE REPORT This single case study examined the separate and sequential outcomes of SCS and CPRP in a 26-year-old patient with a work-related injury resulting in chronic upper extremity pain. This patient was treated within an interdisciplinary CPRP following failure and removal of an SCS. Outcomes were measured by psychological assessments and return-to-work through a 6-month post-CPRP follow-up. CONCLUSIONS Pain intensity decreased following SCS placement and CPRP, while pain-related distress, pain interference, and overall affect improved only after CPRP, with sustained improvements at 6-month follow-up. Patient evidenced improvement following treatment with SCS and CPRP. SCS resulted in improvement in subjective pain and modest improved self-reported activity. CPRP demonstrated marked improvement in pain, self-reported function, and mood with patient eventually returning to work and maintaining most of these gains 6-months after completing CPRP treatment.
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