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Background: Cerebral palsy is the most common brain injury in the pediatric population. Patients with cerebral palsy present different affectations such as decreased muscle strength, gait deviations, impaired proprioception, and spasticity. Isokinetic strengthening programs combined with intensive rehabilitation may improve muscle strength and therefore gait efficiency., Objective: The primary aim of this randomized controlled trial is to compare the effect of an intensive rehabilitation combined with a nonfunctional isokinetic progressive strengthening program to an intensive rehabilitation alone on gait parameters and muscle strength in patients with cerebral palsy. Another goal of this study is to determine whether adding an isokinetic program to intensive rehabilitation is more effective than intensive rehabilitation alone at decreasing spasticity and improving joint position sense in patients with cerebral palsy., Methods: A total of 30 adolescents with spastic diplegia cerebral palsy (Gross Motor Function Classification System levels I to III) will be randomized, by an independent researcher, into a 3-week intensive rehabilitation and isokinetic progressive strengthening group or an intensive rehabilitation control group. Gait parameters, muscle strength, spasticity, and knee joint position sense will be assessed. These variables will be evaluated at baseline (T0) and at the end of the intervention (T1). The intensive rehabilitation will consist of physiotherapy sessions twice a day and hydrotherapy and virtual reality gait training once a day. The isokinetic training group will have a total of 9 supervised isokinetic strength training sessions focusing on knee flexors and extensors with different execution speeds., Results: The protocol has been accepted by the French National Ethics Committee in October 2022. The inclusion of patients will start in November 2022., Conclusions: The combination of intensive rehabilitation with an isokinetic program on knee flexors and extensors has not been studied yet. The findings of this study may determine if an isokinetic strength training program of knee flexors and extensors is beneficial for the improvement of gait parameters, muscle strength, spasticity, and joint position sense in adolescents with spastic diplegia., International Registered Report Identifier (irrid): PRR1-10.2196/43221., (©Mathias Guérin, Benoit Sijobert, Benjamin Zaragoza, Flore Cambon, Laurence Boyer, Karine Patte. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.05.2023.)

Background: Structured treatment interruptions in chronic HIV infection have been explored as a drug-sparing strategy to reduce drug-related adverse events and costs while maintaining CD4 cell counts at a level high enough to prevent the risk of disease progression., Objectives: To test the hypothesis and put a figure on the reduction in total medical costs, we conducted a cost study analysis in the setting of a randomized open-label study comparing an intermittent to a continuous antiretroviral regimen., Patients and Methods: Four hundred three HIV-1-infected adults who were tolerating highly active antiretroviral therapy (HAART), with a nadir CD4 count of 100 cells per microliter or more and a CD4 count above 450 cells per microliter at screening, were randomly assigned to switch to a fixed 8-week off, 8-week on intermittent treatment (IT) or to maintain their current treatment (CT) strategy. The proportions of patients who reached a CD4 cell count below 300 cells per microliter through 96 weeks (primary end point) were not significantly different between arms. Costs were estimated from the viewpoint of the payer over the 96-week study period. Unit costs were provided from the national reimbursement schedules for hospital inpatient and outpatient admissions and ambulatory visits and the national selling price for medications. All analyses were performed on an intention-to-treat basis., Results: Complete cost data were available for 391 patients (197 patients in the IT and 194 in the CT arms). The mean cost in euros (Euro) per patient over the 96 weeks of follow-up (excluding protocol-driven costs) was 9738 in the IT arm vs. 16,162 in the CT arm, a 6424 difference almost entirely due to the difference in HAART cost. Mean protocol-driven costs represented Euro290 in the IT vs. Euro280 in the CT arm. The use of IT achieved a 40% reduction in the total cost of HAART., Conclusions: Reducing by 40% the cost ofHAART medications in a treatment interruption strategy did not increase the costs related to adverse events or consultations.