Clinical Research Directory

Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations

The recovery of walking ability is crucial to promote independence in daily living and is one of the major goal of neuromotor rehabilitation. Currently, standard rehabilitative programs are usually based on straight-walking training (SWT) and the assessment of their effects is performed through functional scales based on straight-walking trajectories, e.g. Timed Up and Go (TUG), 10 meters walking test (10mWT). Curved-walking training (CWT) may be interesting to provide an ecological and challenging context during rehabilitation. Indeed, CWT is based on demanding neural processes that drive an asymmetrical contribution at lower limb level, challenging balance ability and complex adaptation such as body weight shifting in response to centrifugal force and production of different step lengths. Up to now, literature has investigated CWT in healthy adults in terms of muscular activation, kinematics and kinetics of the movement. Results showed that CWT needs a different biomechanical strategy with respect to SWT. Nevertheless CWT has not been investigated in pathological adults. The present study aims at assessing the effectiveness of a rehabilitative physical therapy based on CWT with respect to traditional SWT for the recovery of locomotor abilities in neurological and orthopaedic patients. The hypothesis is that a training based on curved-walking is ecologically meaningful and may be superior with respect to standard training in improving balance, walking abilities, and independence in activity of daily live of patients. A secondary aim of the project is to propose an innovative functional scale based on the timed up and go on curved trajectory (CTUG), and to determine its reliability and responsiveness, establishing the minimum Detectable Change (MDC) and the Minimal Clinically Important Difference (MCID). A single-blind randomized controlled study is being carried out on three different populations: * Post-acute stroke patients * Idiopathic Parkinson Disease * Femoral fracture A healthy group is also being recruited to provide reference values of CTUG. For each of the three populations, subjects are randomized into two groups. The experimental one performs a novel rehabilitative program composed by a 30-minute training on curved trajectory ("S" trajectory composed by two semicircle with a radius of 1.2 m) in addition to usual care. The control group performs an equal dose of traditional treatment on straight trajectories. Both groups undergo 20 90-minutes sessions of training (three times a week for seven weeks). Participants are evaluated at baseline (T0), after training (T1), and at a three-months follow-up visit (T2). The primary outcome measure is the 10mWT (minimal clinically important difference of 0.16 m/s identified by Tilson and colleagues). On the basis of this measure, a sample size of 70 subjects for each population was computed.

Volume Dependent Effect of Pericapsular Nerve Block

In PENG block technique, the local anesthetic agent is injected between the psoas tendon and the pubic ramus to block the sensory branches of the nerves which innervates the hip capsule for providing analgesia without causing muscle weakness. Since the PENG block is a facial plane block, it causes a volume dependent distribution. There are a few case reposts and cadaveric studies on volume dependent effect of analgesia and motor weakness of PENG block. In our study, we aimed to evaluate the clinical effects of the volume-dependent efficacy of PENG block.

Outpatient Floor Pedal Bike Utilization

The goals of this clinical trial are: to test the feasibility of identifying patients and getting patients the floor pedal bikes, to test how well floor pedal bikes help patients with lower body injuries heal, and to test methods of patient self-reported logs for home pedal bike use. Participants will be given a floor pedal bike at first post-operative appointment where weightbearing restrictions are lifted (weight-bearing as tolerated) along with instructions on utilization. Participants will be asked to complete patient reported outcome measure surveys at each follow-up visit.

Effect of a Femoral Venting Hole on Embolic Load in Prophylactic Intramedullary Nailing

The purpose of this study is to measure intraoperative embolic burden during prophylactic intramedullary nailing of impending femur fractures in patients treated with versus without venting, to find the association between embolic burden and intraoperative physiologic changes, measured using standard anesthesia monitors and charted data, to measure Immediate and short-term cardiopulmonary outcomes assessed during hospitalization and to assess procedure-related complications associated with venting

Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures

The goal of this clinical trial is to evaluate the safety and efficacy of robot-assisted closed reduction for patients with femoral shaft fractures. The main questions it aims to answer are: Does robot-assisted closed reduction provide a statistically significant improvement in the excellent and good reduction rates compared to conventional surgeon-performed reduction? How do the two reduction methods compare in terms of surgical efficiency, fracture healing, and patient functional outcomes? Researchers will compare the robot-assisted closed reduction group to the conventional surgeon-performed reduction group to see if robot-assisted surgery improves the precision of fracture reduction, stability of alignment, and post-operative functional recovery while minimizing trauma. Participants will: Undergo standardized screening to ensure they meet the inclusion criteria for acute, unilateral, closed femoral shaft fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] classification 32). Be randomized in a 1:1 ratio to receive either robot-assisted closed reduction or traditional surgeon-performed closed reduction, both followed by internal fixation. Complete standardized perioperative management and follow-up assessments at 1, 3, 6, and 12 months post-surgery, including functional scales such as the Lower Extremity Functional Scale (LEFS) and the EuroQol Five-Dimensional Five-Level questionnaire (EQ-5D-5L), as well as radiographic imaging to monitor bone healing and potential complications.

Effect of Remimazolam and Propofol on Postoperative Delirium

Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.

Dual Implant Versus Single Implant Distal End of Femur

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies. This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery

To compare the immediate and postoperative analgesic efficacy of S-FICB and PENG block will be the objective. The use of ultrasonography in anesthesia has helped the anesthetist to see the nerve, needle and the distribution of the drug, thereby enhancing the chances of a favorable outcome of the nerve block. Grade A recommendation for an ultrasound guided approach to the peripheral nerve blocks is supported by level Ib evidence for a shortened time for the onset of sensory block, decreased performance time and lower drug doses10. Although individually both the blocks have been studied, there are only a handful of studies comparing both techniques under ultrasound guidance for making patient positioning for spinal anesthesia easy. And no local data is available comparing these blocks. So, we want to compare the analgesic efficacy of USG PENG block with USG S-FICB block in patients with fracture femur in reducing pain associated with positioning (sitting) for subarachnoid block, duration of analgesia, opioid sparing effect and complications. So that procedure with better analgesic efficacy and less complications will be included in our local guidelines as a part of multimodal analgesia.

Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation.

Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached \>120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle. There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT).