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Predictors and biomarkers of treatment gains in a clinical stroke trial targeting the lower extremity.

ABSTRACT: Behavioral measures are often used to distinguish subgroups of patients with stroke (eg, to predict treatment gains, stratify clinical trial enrollees, or select rehabilitation therapy). In studies of the upper extremity, measures of brain function using functional magnetic resonance imaging (fMRI) have also been found useful, but this approach has not been examined for the lower extremity. The current study hypothesized that an fMRI-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains. Biomarkers of treatment gains were also explored.Patients with hemiparesis 1 to 12 months after stroke were enrolled in a double-blind, placebo-controlled, randomized clinical trial of ropinirole+physical therapy versus placebo+physical therapy, results of which have previously been reported (NCT00221390).(15) Primary end point was change in gait velocity. Enrollees underwent baseline multimodal assessment that included 19 measures spanning 5 assessment categories (medical history, impairment, disability, brain injury, and brain function), and also underwent reassessment 3 weeks after end of therapy.In bivariate analysis, 8 baseline measures belonging to 4 categories (medical history, impairment, disability, and brain function) significantly predicted change in gait velocity. Prediction was strongest, however, using a multivariate model containing 2 measures (leg Fugl-Meyer score and fMRI activation volume within ipsilesional foot sensorimotor cortex). Increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains.A multimodal model incorporating behavioral and fMRI measures best predicted treatment-induced changes in gait velocity in a clinical trial setting. Results also suggest potential use of fMRI measures as biomarkers of treatment gains.

SUBMITTER: Burke E

PROVIDER: S-EPMC4129459 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Predictors and biomarkers of treatment gains in a clinical stroke trial targeting the lower extremity.

Burke Erin E Dobkin Bruce H BH Noser Elizabeth A EA Enney Lori A LA Cramer Steven C SC

Stroke 20140624 8

<h4>Background and purpose</h4>Behavioral measures are often used to distinguish subgroups of patients with stroke (eg, to predict treatment gains, stratify clinical trial enrollees, or select rehabilitation therapy). In studies of the upper extremity, measures of brain function using functional magnetic resonance imaging (fMRI) have also been found useful, but this approach has not been examined for the lower extremity. The current study hypothesized that an fMRI-based measure of cortical funct ...[more]

PMID: 25070961

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Project description:Background and objectivesFunctional outcomes are important for oncology patients undergoing lower extremity reconstruction. The objective of the current study was to describe patient reported function after surgery and identify predictors of postoperative function in musculoskeletal oncology patients undergoing lower extremity endoprosthetic reconstruction.MethodsWe performed a cohort study with functional outcome data from the recently completed Prophylactic Antibiotic Regimens in Tumor Surgery (PARITY) trial. We utilized the 100-point Toronto Extremity Salvage Score (TESS), which was administered pre-operatively and at 3, 6 and 12 months post-operatively. Higher scores indicate better physical functioning, and the minimally important difference is 11 points. We calculated mean functional scores at each timepoint after surgery and developed a logistic regression model to explore predictors of failure to achieve excellent post-operative function (TESS ≥ 80) at 1 year after surgery.ResultsThe 555 patients included in our cohort showed important functional improvement from pre-surgery to 1 year post-surgery (mean difference 14.9 points, 95%CI 12.2 to 17.6; p < 0.001) and 64% achieved excellent post-operative function. Our adjusted regression model found that poor (TESS 0-39) pre-operative function (odds ratio [OR] 3.3, 95%CI 1.6 to 6.6); absolute risk [AR] 24%, 95%CI 8% to 41.2%), older age (OR per 10-year increase from age 12, 1.32, 95%CI 1.17, 1.49; AR 4.5%, 95%CI 2.4% to 6.6%), and patients undergoing reconstruction for soft-tissue sarcomas (OR 2.3, 95%CI 1.03 to 5.01; AR 15.3%, 95%CI 0.4% to 34.4%), were associated with higher odds of failing to achieve an excellent functional outcome at 1-year follow-up. Patients undergoing reconstruction for giant cell tumors were more likely to achieve an excellent functional outcome post-operatively (OR 0.40, 95%CI 0.17 to 0.95; AR -9.9%, 95%CI -14.4% to -0.7%).ConclusionsThe majority of patients with tumors of the lower extremity undergoing endoprosthetic reconstruction achieved excellent function at 1 year after surgery. Older age, poor pre-operative function, and endoprosthetic reconstruction for soft tissue sarcomas were associated with worse outcomes; reconstruction for giant cell tumors was associated with better post-operative function.Level of evidenceTherapeutic Level IV.

Project description:BackgroundBalance impairments are common in patients with infratentorial stroke. Although robot-assisted gait training (RAGT) exerts positive effects on balance among patients with stroke, it remains unclear whether such training is superior to conventional physical therapy (CPT). Therefore, we aimed to investigate the effects of RAGT combined with CPT and compared them with the effects of CPT only on balance and lower extremity function among survivors of infratentorial stroke.MethodsThis study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation hospital. Patients (n = 19; 16 men, three women; mean age: 47.4 ± 11.6 years) with infratentorial stroke were randomly allocated to either group A (4 weeks of RAGT+CPT, followed by 4 weeks of CPT+CPT) or group B (4 weeks of CPT+CPT followed by 4 weeks of RAGT+CPT). Changes in dynamic and static balance as indicated by Berg Balance Scale scores were regarded as the primary outcome measure. Outcome measures were evaluated for each participant at baseline and after each 4-week intervention period.ResultsNo significant differences in outcome-related variables were observed between group A and B at baseline. In addition, no significant time-by-group interactions were observed for any variables, indicating that intervention order had no effect on lower extremity function or balance. Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention.ConclusionRAGT produces clinically significant improvements in balance and lower extremity function in individuals with infratentorial stroke. Thus, RAGT may be useful for patients with balance impairments secondary to other pathologies.Trial registrationClinicalTrials.gov Identifier NCT02680691. Registered 09 February 2016; retrospectively registered.

Project description:ImportanceThe use of perioperative, prophylactic, intravenous antibiotics is standard practice to reduce the risk of surgical site infection after oncologic resection and complex endoprosthetic reconstruction for lower extremity bone tumors. However, evidence guiding the duration of prophylactic treatment remains limited.ObjectiveTo assess the effect of a 5-day regimen of postoperative, prophylactic, intravenous antibiotics compared with a 1-day regimen on the rate of surgical site infections within 1 year after surgery.Design, setting, and participantsThis randomized clinical superiority trial was performed at 48 clinical sites in 12 countries from January 1, 2013, to October 29, 2019. The trial included patients with a primary bone tumor or a soft tissue sarcoma that had invaded the femur or tibia or oligometastatic bone disease of the femur or tibia with expected survival of at least 1 year who required surgical management by excision and endoprosthetic reconstruction. A total of 611 patients were enrolled, and 7 were excluded for ineligibility.InterventionsA 1- or 5-day regimen of postoperative prophylactic intravenous cephalosporin (cefazolin or cefuroxime) that began within 8 hours after skin closure and was administered every 8 hours thereafter. Those randomized to the 1-day regimen received identical saline doses every 8 hours for the remaining 4 days; patients, care providers, and outcomes assessors were blinded to treatment regimen.Main outcomes and measuresThe primary outcome in this superiority trial was a surgical site infection (superficial incisional, deep incisional, or organ space) classified according to the criteria established by the Centers for Disease Control and Prevention within 1 year after surgery. Secondary outcomes included antibiotic-related complications, unplanned additional operations, oncologic and functional outcomes, and mortality.ResultsOf the 604 patients included in the final analysis (mean [SD] age, 41.2 [21.9] years; 361 [59.8%] male; 114 [18.9%] Asian, 43 [7.1%] Black, 34 [5.6%] Hispanic, 15 [2.5%] Indigenous, 384 [63.8%] White, and 12 [2.0%] other), 293 were randomized to a 5-day regimen and 311 to a 1-day regimen. A surgical site infection occurred in 44 patients (15.0%) allocated to the 5-day regimen and in 52 patients (16.7%) allocated to the 1-day regimen (hazard ratio, 0.93; 95% CI, 0.62-1.40; P = .73). Antibiotic-related complications occurred in 15 patients (5.1%) in the 5-day regimen and in 5 patients (1.6%) allocated to the 1-day regimen (hazard ratio, 3.24; 95% CI, 1.17-8.98; P = .02). Other secondary outcomes did not differ significantly between treatment groups.Conclusions and relevanceThis randomized clinical trial did not confirm the superiority of a 5-day regimen of postoperative intravenous antibiotics over a 1-day regimen in preventing surgical site infections after surgery for lower extremity bone tumors that required an endoprosthesis. The 5-day regimen group had significantly more antibiotic-related complications.Trial registrationClinicalTrials.gov Identifier: NCT01479283.

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Predictors and biomarkers of treatment gains in a clinical stroke trial targeting the lower extremity.

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Predictors and biomarkers of treatment gains in a clinical stroke trial targeting the lower extremity.

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