Clinical trials

This study investigates whether wearing a thoracic spinal orthosis (back brace) improves functional mobility in physically active older adults (60 years and older) with thoracic hyperkyphosis, an excessive forward curvature of the upper spine that is associated with slower walking, reduced muscle strength, and a higher risk of falls. Who can participate? Community-dwelling adults aged 60 years or older with thoracic hyperkyphosis (Cobb angle of 40 degrees or more), who walk independently without assistive devices and actively participate in the supervised exercise program for older adults (PIAFI) at the Pontifical Catholic University of Rio Grande do Sul (PUCRS), Porto Alegre, Brazil. How does the study work? Participants are randomly assigned, in equal numbers, to one of four groups: 1. Triple-Adjustable Posture Corrector (Mercur, Brazil), a three-point pressure orthosis; 2. Generation Dynamic Osteoporosis Brace (Bort, Germany), a dynamic elastic-resistance orthosis; 3. Placebo orthosis, similar in appearance but without corrective function; 4. Control group, which does not wear any orthosis. Participants in the orthosis groups wear their device for 16 weeks following a progressive schedule (from 1-2 hours per day in the first weeks up to 4 hours per day), recording daily use in a weekly logbook. All participants continue their usual supervised exercise program. What is measured? At the start (baseline) and after 16 weeks, participants undergo: gait analysis on a pressure platform (baropodometry), isokinetic dynamometry of the shoulder rotator and trunk muscles, and physical activity monitoring with a waist-worn accelerometer. These measures are combined into a Functional Mobility Score (primary outcome). Participants, outcome assessors, and the statistician are blinded to group allocation. Why is this study important? Evidence on the effects of thoracic orthoses on gait, muscle torque, and physical activity in older adults with hyperkyphosis is limited. The results may help clinicians decide whether, and which type of, thoracic orthosis can support mobility in this population.

This study aims to evaluate bone formation in grafts in terms of its quality (density), quantity (volume) and maturation obtained with the application of a tissue-engineered bone grafting compound containing concentrated autogenous cell-culture medium (CM) and a synthetic bone substitute. The present study was designed as an experimental prospective split-mouth randomized controlled clinical trial. After protocol approval by the Research Ethics Committee, a total of 20 consecutive participants in need of maxillary reconstruction aiming implant-supported oral rehabilitation will be invited to join the study. To collect autogenous adipose tissue-derived mesenchymal stem cells (hASCs), an outpatient lipoplasty procedure at the abdominal area of each patient will be performed. To isolate and expand hASCs from the lipoaspirate, specific cell culture protocols will be followed, resulting in cultured viable cells and their conditioned medium (CM). Cells and CM will be then separated by a sequence of filters and centrifugation, and isolated CM will be frozen. ELISA will analyze the presence of chemokines and their concentration in CM before grafting. Following pre-op surgical planning, both maxillary sinuses of each patient will be grafted internally applying a lateral window to each sinus. The bony floor of the test maxillary sinus will be augmented with synthetic bone substitute (BoneCeramic™ 1-2 mm) mixed with 10 to 15 ml of CM (test). The control site will receive bone substitute with saline. Lateral windows in both sinuses will be then closed with a collagen membrane (Bio-Gide™). After 6 months, first-stage implant surgery will be performed placing 6 implants in each patient. Registration of implant stability by manual torque wrench will be performed. Also, bone biopsies from each drilled implant site will be collected for histology, histomorphometry and immunohistochemistry (RT-PCR). Tomographic evaluation of the bone formation will include cone beam computed tomographies (CBCTs) at pre-operative \[Baseline\], 90 \[T1\] and 180 \[T2 = implant placement\] days for bone 3D image analysis.

This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach. In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance. Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months.