Dataset Information

Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial.

ABSTRACT: Clinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits.To compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation.Phase 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.Structured, 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.The 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).Among 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.Among 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.clinicaltrials.gov Identifier: NCT00871715.

SUBMITTER: Winstein CJ

PROVIDER: S-EPMC4795962 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial.

Winstein Carolee J CJ Wolf Steven L SL Dromerick Alexander W AW Lane Christianne J CJ Nelsen Monica A MA Lewthwaite Rebecca R Cen Steven Yong SY Azen Stanley P SP

JAMA 20160201 6

<h4>Importance</h4>Clinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits.<h4>Objective</h4>To compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation.<h4>Design, setting, and participants</h4>Phase 3, pragmatic, single-blind randomized trial among 361 participants with moderate motor ...[more]

PMID: 26864411

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Project description:ObjectiveTo 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.DesignRasch 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.SettingOutpatient stroke rehabilitation.ParticipantsICARE participants (N=361).InterventionsNot applicable.Main outcome measuresItem difficulties, person abilities, and sample size.ResultsBecause 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).ConclusionsIn 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.

Project description:Background and objectivePrediction of voluntary upper extremity (UE) movement recovery is largely unknown in patients with little voluntary UE movement at admission. The present study aimed to investigate (1) the extent and variation of voluntary UE movement recovery, and (2) the best predictive model of the recovery of voluntary UE movement by clinical variables in patients with severe UE paresis.DesignProspective cohort study.Methods140 (out of 590) stroke patients with severe UE paresis completed all assessments. Voluntary UE movement was assessed using the UE subscale of the Stroke Rehabilitation Assessment of Movement (STREAM-UE). Two outcome measures, STREAM-UE scores at discharge (DC(STREAM-UE)) and changes between admission and discharge (Δ(STREAM-UE)), were investigated to represent the final states and improvement of the recovery of voluntary UE movement. Stepwise regression analyses were used to investigate 19 clinical variables and to find the best predictive models of the two outcome measures.ResultsThe participants showed wide variation in both DC(STREAM-UE) and Δ(STREAM-UE). 3.6% of the participants almost fully recovered at discharge (DC(STREAM-UE) > 15). A large improvement (Δ(STREAM-UE) >= 10) occurred in 16.4% of the participants, while 32.9% of the participants did not have any improvement. The four predictors for the DC(STREAM-UE) (R(2) = 35.0%) were 'baseline STREAM-UE score', 'hemorrhagic stroke', 'baseline National Institutes of Health Stroke Scale (NIHSS) score', and 'cortical lesion excluding primary motor cortex'. The three predictors for the Δ(STREAM-UE) (R(2) = 22.0%) were 'hemorrhagic stroke', 'baseline NIHSS score', and 'cortical lesion excluding primary motor cortex'.ConclusionsRecovery of voluntary UE movement varied widely in patients with severe UE paresis after stroke. The predictive power of clinical variables was poor. Both results indicate the complex nature of voluntary UE movement recovery in patients with severe UE paresis after stroke.

Project description:ObjectiveTo investigate the potential benefits of 3 therapeutic instrumental music performance (TIMP)-based interventions in rehabilitation of the affected upper-extremity (UE) for adults with chronic poststroke hemiparesis.DesignRandomized-controlled pilot study.SettingUniversity research facility.ParticipantsCommunity-dwelling volunteers (N=30; 16 men, 14 women; age range, 33-76 years; mean age, 55.9 years) began and completed the protocol. All participants had sustained a unilateral stroke more than 6 months before enrollment (mean time poststroke, 66.9 months).InterventionTwo baseline assessments, a minimum of 1 week apart; 9 intervention sessions (3 times/week for 3 weeks), in which rhythmically cued, functional arm movements were mapped onto musical instruments; and 1 post-test following the final intervention. Participants were block-randomized to 1 of 3 conditions: group 1 (45 minutes TIMP), group 2 (30 minutes TIMP, 15 minutes metronome-cued motor imagery [TIMP+cMI]), and group 3 (30 minutes TIMP, 15 minutes motor imagery without cues [TIMP+MI]). Assessors and investigators were blinded to group assignment.Main outcome measuresFugl-Meyer Upper-Extremity (FM-UE) and Wolf Motor Function Test- Functional Ability Scale (WMFT-FAS). Secondary measures were motor activity log (MAL)-amount of use scale and trunk impairment scale.ResultsAll groups made statistically significant gains on the FM-UE (TIMP, P=.005, r=.63; TIMP+cMI, P=.007, r=.63; TIMP+MI, P=.007, r=.61) and the WMFT-FAS (TIMP, P=.024, r=.53; TIMP+cMI, P=.008, r=.60; TIMP+MI, P=.008, r=.63). Comparing between-group percent change differences, on the FM-UE, TIMP scored significantly higher than TIMP+cMI (P=.032, r=.57), but not TIMP+MI. There were no differences in improvement on WMFT-FAS across conditions. On the MAL, gains were significant for TIMP (P=.030, r=.54) and TIMP+MI (P=.007, r=.63).ConclusionTIMP-based techniques, with and without MI, led to significant improvements in paretic arm control on primary outcomes. Replacing a physical training segment with imagery-based training resulted in similar improvements; however, synchronizing internal and external cues during auditory-cMI may pose additional sensorimotor integration challenges.

Project description:BackgroundTranscutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising brain stimulation modality in poststroke upper extremity rehabilitation. Although several studies have examined the safety and reliability of taVNS, the mechanisms underlying motor recovery in stroke patients remain unclear.ObjectivesThis study aimed to investigate the effects of taVNS paired with task-oriented training (TOT) on upper extremity function in patients with subacute stroke and explore the potential underlying mechanisms.MethodsIn this double-blinded, randomized, controlled pilot trial, 40 patients with subacute stroke were randomly assigned to two groups: the VNS group (VG), receiving taVNS during TOT, and the Sham group (SG), receiving sham taVNS during TOT. The intervention was delivered 5 days per week for 4 weeks. Upper extremity function was measured using the Fugl-Meyer Assessment-Upper Extremity (FMA-UE), the Action Research Arm Test (ARAT). Activities of daily living were measured by the modified Barthel Index (MBI). Motor-evoked potentials (MEPs) were measured to evaluate cortical excitability. Assessments were administered at baseline and post-intervention. Additionally, the immediate effect of taVNS was detected using functional near-infrared spectroscopy (fNIRS) and heart rate variability (HRV) before intervention.ResultsThe VG showed significant improvements in upper extremity function (FMA-UE, ARAT) and activities of daily living (MBI) compared to the SG at post-intervention. Furthermore, the VG demonstrated a higher rate of elicited ipsilesional MEPs and a shorter latency of MEPs in the contralesional M1. In the VG, improvements in FMA-UE were significantly associated with reduced latency of contralesional MEPs. Additionally, fNIRS revealed increased activation in the contralesional prefrontal cortex and ipsilesional sensorimotor cortex in the VG in contrast to the SG. However, no significant between-group differences were found in HRV.ConclusionThe combination of taVNS with TOT effectively improves upper extremity function in patients with subacute stroke, potentially through modulating the bilateral cortex excitability to facilitate task-specific functional recovery.

Dataset Information

Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial.

Publications

Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial.

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