Combining specific task-oriented training with manual therapy to improve balance and mobility in patients after stroke: a mixed methods pilot randomised controlled trial.

PURPOSE: In absence of existing studies, to describe changes in balance and mobility, following specific task-oriented training (TOT), its combination with talocrural manual therapy (MT-TOT) or no intervention, in chronic stroke patients. To explore the feasibility of a full-scale randomised controlled trial (RCT) based on criteria of recruitment, retention and adherence rates, adverse events, falls and acceptability of the intervention. MATERIALS AND METHODS: Using an assessor-blinded pilot RCT, 36 stroke patients were allocated to either MT-TOT, TOT, or controls. Supervised interventions were performed 45 min, 2×/weekly, for 4 weeks, and home-based practice 20 min, 4x/weekly for 4 weeks. Qualitative interviews evaluated intervention acceptability. Outcomes of balance, mobility, ankle dorsiflexion range of motion (ROM), falls and health-related quality of life (HRQoL) were assessed at baseline, post-intervention and 4-week follow-up. RESULTS: Preliminary efficacy of MT-TOT and TOT was shown in improving balance (effect size 0.714), walking speed (0.683), mobility (0.265), dual-tasking mobility (0.595), falls (0.037), active and passive talocrural ROM (0.603; 0.751) and activities and social participation related HRQoL domains (0.332-0.784) in stroke patients. The feasibility of a larger RCT was confirmed. CONCLUSIONS: Specific MT-TOT and TOT appeared effective and are feasible in stroke patients. A larger RCT is needed to validate the results.Trial Registration: German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068.

A specific goal- and task-oriented training involving timed mobility and dynamic balance activities based on the demands of daily life, of high intensity and progressed in difficulty according to predefined criteria is feasible in patients after stroke.In this mixed methods pilot study patients indicated high acceptability of task-oriented training with and without ankle mobilisations, with their descriptions being in line with the Theoretical Framework of Acceptability.Specific task-oriented training and its combination with talocrural joint manual therapy improved balance, mobility, talocrural dorsiflexion range of motion and some domains of health-related quality of life in people after stroke.

Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies.

Background: Mirikizumab, an anti-IL-23p19 antibody, demonstrated efficacy in phase 3, randomized, double-blind, placebo-controlled LUCENT-1 (induction/NCT03518086) and LUCENT-2 (maintenance/NCT03524092) ulcerative colitis (UC) studies. We evaluated the effect of mirikizumab on quality-of-life (QoL) outcomes in these studies. Methods: In LUCENT-1, 1162 patients with moderately-to-severely active UC were randomized 3:1 to receive mirikizumab 300 mg intravenous or placebo every 4 weeks (Q4W) for 12 weeks. In LUCENT-2, mirikizumab induction responders (N = 544) were re-randomized 2:1 to receive mirikizumab 200 mg subcutaneous or placebo Q4W through week (W) 40 (W52 of treatment). QoL was assessed at W12 and W52 using patient-reported outcomes. Treatments were statistically compared using analysis of covariance model (continuous outcomes) and Cochran-Mantel-Haenszel test (binary outcomes). Results: At W12 and W52, mirikizumab showed significant improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) total and domain scores (P < .001); 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS), Mental Component Summary (MCS), and domain scores (P < .05); EQ-5D-5L scores (P < .001); Work Productivity and Activity Impairment Questionnaire (UC) scores (P < .05); Patient Global Rating of Severity (P < .001); and Patient Global Rating of Change (P < .01) scores. A significantly higher proportion of mirikizumab-treated patients achieved IBDQ response (W12: 72.7% vs 55.8%; W52: 79.2% vs 49.2%; P < .001), IBDQ remission (W12: 57.5% vs 39.8%; W52: 72.3% vs 43.0%; P < .001), and clinically important improvements in PCS (W12: 50.6% vs 41.5%; W52: 61.9% vs 36.9%; P < .01) and MCS (W12: 44.2% vs 37.8%; W52: 51.2% vs 34.6%; P < .05) scores. Conclusions: Mirikizumab improved QoL in patients with moderately-to-severely active UC in phase 3 LUCENT-1 and LUCENT-2 studies. Clinical trials registration number: LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.

Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial.

BACKGROUND: Large studies have shown that stroke is among the most relevant causes of acquired adult disability. Walking and balance impairment in stroke survivors often contribute to a restriction in daily activities and social participation. Task-oriented training (TOT) is an effective treatment strategy and manual therapy (MT) is used successfully to enhance ankle joint flexibility in this population. No study, however, has compared TOT against its combination with MT in a randomised controlled trial. Aims of this pilot study are therefore to explore the feasibility of a full-scale RCT using predefined feasibility criteria. Secondary aims are to explore the preliminary effects of specific TOT with a combined specific TOT-MT versus a control group in people post stroke. METHODS: This is a protocol of a 4-week prospective randomised controlled parallel pilot trial in people post stroke at the chronic stage with limited upper ankle joint mobility and an impairment in balance and mobility. At a German outpatient therapy centre using 1:1:1 allocation, 36 patients will be randomised into one of three groups: 15-min talocrural joint MT plus 30-min specific TOT (group A), 45-min specific TOT (group B), and controls (group C). Training will be goal-oriented including tasks that are based on daily activities and increased in difficulty utilising predefined progression criteria based on patients' skill levels. Interventions will be provided face-to-face 2 times per week, for 4 weeks, in addition to 20-min concurrent x4 weekly home-based training sessions. Data will be collected by blinded assessors at baseline, post-intervention and 4-week follow-up. The primary outcome will be feasibility assessed by recruitment, retention and adherence rates, compliance, adverse events, falls and the acceptability of the intervention. Secondary outcomes will be walking speed, single and dual tasking functional mobility, ankle range of motion, disability and health-related quality of life. DISCUSSION: Feasibility provided, results from this study will be used to calculate the sample size of a larger randomised controlled trial to investigate the effects of specific TOT and specific TOT-MT compared to a post stroke control group. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00023068. Registered on 21.09.2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023068 .

Students' Perceptions on a Business Plan Assignment for an Ambulatory Care Pharmacy Elective.

Objective. To evaluate a business-centered assignment implemented in a pharmacy elective course at two different institutions and analyze student perceptions of the delivery platforms used and the value and utility of the assignment. Methods. The ambulatory care electives at Butler University and Samford University introduce students to the expanding role of the ambulatory care pharmacist, emphasizing business plan development for new ambulatory care pharmacy services. As part of the elective, students are asked to work in groups to complete a business plan for a new ambulatory care service of their choosing. A survey was conducted to assess student perceptions on the assignment. Results. Of the 58 students who completed the business plan assignment, 49 completed the survey and were included in the data analysis. Overall, 100% of Samford students and 97% of Butler students either strongly agreed or agreed that the business plan was an innovative assignment unlike others completed in the curriculum. Samford students strongly agreed (100%) that if asked by a future employer to develop a new pharmacy service, concepts learned from this assignment would be useful, compared to 59% of Butler students who felt this way. While both the web and written delivery platforms had identical learning outcomes, the written business plan was the approach that the majority of students were more comfortable using. Conclusion. The business plan assignment was used as a method to familiarize students with the process of developing new ambulatory care pharmacy services. Based on survey results, the students perceived this to be an innovative assignment that allowed them to feel confident in developing and communicating ambulatory care business plans. As the practice of ambulatory care pharmacy expands, assignments such as this can be included in the pharmacy curriculum to meet the need for teaching effective business strategies to future pharmacists.