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Wounds and Injuries clinical trials

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NCT ID: NCT04879862 Recruiting - Clinical trials for Spinal Cord Injuries

Locomotor and Bladder Function in Individuals With Acute Spinal Cord Injury

MC-PP-3
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.

NCT ID: NCT04875052 Recruiting - Clinical trials for Osteoarthritis, Knee

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Start date: January 11, 2021
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to evaluate the effects of vibration on factors related to the risks of post-traumatic knee osteoarthritis and secondary anterior cruciate ligament (ACL) injury in individuals who have undergone anterior cruciate ligament reconstruction surgery (ACLR). The main objectives are to compare the effects of Standard rehabilitation vs. rehabilitation that includes whole body vibration (WBV) or local muscle vibration (LMV) on: - Quadriceps muscle function - Gait biomechanics linked to post-traumatic knee osteoarthritis development - Patient self-report outcomes - MRI indicators of knee joint health and muscle quality - Landing biomechanics linked to secondary ACL injury risk - Evidence-based return-to-physical-activity criteria Participants will be assigned to 1 of 3 groups (standard rehabilitation, standard rehabilitation + WBV, or standard rehabilitation + LMV) and will complete assessments of quadriceps function, gait biomechanics, landing biomechanics, functional ability, patient-report outcomes, and MRI 1, 6, and 12 months after ACLR. Researchers will compare the groups to see if vibration embedded in ACLR rehabilitation improves joint health outcomes.

NCT ID: NCT04871893 Recruiting - Covid19 Clinical Trials

Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy

multiECCO2R
Start date: March 25, 2022
Phase: N/A
Study type: Interventional

Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal replacement therapy (CRRT) in patients presenting with hypercapnia due to acute lung failure and acute kidney injury.

NCT ID: NCT04869059 Recruiting - Clinical trials for Traumatic Brain Injury

Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation

HDtDCS-TBI
Start date: August 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in military veteran participants with histories of traumatic brain injuries. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.

NCT ID: NCT04856449 Recruiting - Trauma Clinical Trials

DBT Skills Plus EMDR for BPD and Trauma

TT-BPD
Start date: September 6, 2021
Phase: N/A
Study type: Interventional

Borderline Personality Disorder (BPD) is a severe disorder that frequently co-occurs with post-traumatic stress disorder (PTSD). The comorbidity of BPD and PTSD is more disabling, predicting lower rates of BPD remission. Dialectical behavioral skills training (DBT-ST), is a group-delivered training that covers four types of skills: emotion regulation, mindfulness, interpersonal effectiveness and distress tolerance. As a stand-alone treatment, research suggest that DBT-ST is an efficacious treatment for BPD. In parallel, EMDR has emerged in last years as an efficacious approach to adult trauma. However, so far, the efficacy of EMDR to treat trauma in populations with BPD diagnosis has not been tested. The present pilot randomized-controlled clinical trial aims to test whether a combination of DBT-ST plus EMDR could be efficacious to treat trauma in individuals with BPD. 40 participants will be recruited from the BPD Unit at the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain) and will be randomized (1:1) to DBT-ST + EMDR or DBT-ST alone. The primary outcome will be the reduction of PTSD symptoms. In addition, symptom-related variables will be collected before and after the interventions. This will be the first study to test the combination of DBT-ST and EMDR.

NCT ID: NCT04856241 Recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Making Football Safer for Women: Implementing an Injury Prevention Program

Prep-to-Play
Start date: April 22, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to determine how we can best support coaches to implement an injury prevention (IP) program (Prep-to-Play) in female community Australian Football. We will recruit at least 140 female community football teams from 15 different football leagues in Victoria, Australia. Teams will be competing in U16, U17, U18, U19 or open womens competitions. We will train and support coaches to implement the IP program and evaluate the effects of the IP program on injuries across two football seasons.

NCT ID: NCT04855396 Recruiting - Clinical trials for Traumatic Brain Injury

The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)

Start date: January 19, 2021
Phase:
Study type: Observational

There are no therapeutic agents that have been shown to improve outcomes from severe traumatic brain injury (TBI). Critical barriers to progress in developing treatments for severe TBI are the lack of: 1) monitoring biomarkers for assessing individual patient response to treatment; 2) predictive biomarkers for identifying patients likely to benefit from a promising intervention. Currently, clinical examination remains the fundamental tool for monitoring severe TBI patients and for subject selection in clinical trials. However, these patients are typically intubated and sedated, limiting the utility of clinical examinations. Validated monitoring and predictive biomarkers will allow titration of the dose of promising therapeutics to individual subject response, as well as make clinical trials more efficient by enabling the enrollment of subjects likely to benefit. Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and high sensitivity c-reactive protein (hsCRP) are promising biomarkers that may be useful as 1) monitoring biomarkers; 2) predictive biomarkers in severe TBI trials. Although the biological rationale supporting their use is strong, significant knowledge gaps remain. To address these gaps in knowledge, we propose an ancillary observational study leveraging an ongoing severe TBI clinical trial that is not funded to collect biospecimen. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial that seeks to determine the dose of hyperbaric oxygen therapy (HBOT) that that has the highest likelihood of demonstrating efficacy in a phase III trial. The proposed study will: 1) validate the accuracy of candidate monitoring biomarkers for predicting clinical outcome; 2) determine the treatment effect of different doses of HBOT on candidate monitoring biomarkers; and 3) determine whether there is a biomarker defined subset of severe TBI that responds favorably to HBOT. This proposal will: 1) inform a go/no-go decision for a phase III trial of HBOT by providing adjunctive evidence of the effect of HBOT on key biological pathways through which HBOT is hypothesized to affect outcome; 2) provide evidence to support further study of the first monitoring biomarkers of severe TBI; 3) increase the likelihood of success of a phase III trial by identifying the sub-population of severe TBI likely to benefit from HBOT; 4) create a repository of TBI biospecimen which may be accessed by other investigators. This study is related to NCT04565119

NCT ID: NCT04855214 Recruiting - Amputation Clinical Trials

Evaluating the Experience of Upper Limb Prosthesis Use

Start date: December 16, 2020
Phase:
Study type: Observational

Our goal is to understand the critical factors associated with outcome acceptance following upper limb loss. We aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. This conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed two-year study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 18 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices.

NCT ID: NCT04849676 Recruiting - Clinical trials for Incomplete Spinal Cord Injury

Neurofeedback to Improve Spasticity After Incomplete Spinal Cord Injury

Start date: August 31, 2021
Phase: N/A
Study type: Interventional

After incomplete spinal cord injury (iSCI), many people still have control over their upper and/or lower limbs, but secondary conditions such as spasticity impair the function they have left. Spasticity includes increased reflex response and muscle tone, and is often painful. In this study we want to test a rehabilitation therapy to reduce spasticity after iSCI and improve participants' control over their extremities. The study involves recording participants' brain signals (EEG) and displaying them on a computer, so that they learn to control specific features derived from their brain waves. This is called neurofeedback (NF). Two studies conducted in our group that explored NF effect on central neuropathic pain in iSCI reported as incidental finding a decrease in spasms, muscle tightness and foot drop. The effect of NF is immediate and lasts up to 24 hours. In this study, we will explore systematically the short- and medium-term effect of NF on a larger number of iSCI, to inform a potential randomized clinical trial. Gaining control over one's brain activity requires practice and 80-90% people eventually learn the skill. Each participant will therefore attend five sessions of NF taking no longer than two hours each. 20 participants will be recruited and assigned to either upper or lower limb spasticity groups. This will allow us to determine if the mechanism of NF differs between arms and legs. Participants will be further grouped into sub-acute and chronic groups, depending on the time since injury, to pinpoint at what stage post-injury NF is the most effective. All groups will receive the same number of NF sessions. The primary outcome of this study is the change in spasticity of the hand or leg, as measured by the Modified Ashworth Scale (MAS). Secondary outcomes include use of arm/leg, quality of life, and the relation between functional improvement and EEG changes. Outcomes will be compared before/after each session, and before/after the whole intervention period, both inter- and intra-group.

NCT ID: NCT04849143 Recruiting - Diabetes Clinical Trials

The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

There has been no study yet on the effect of stingless bee honey (Kelulut honey) produced by Melipolini sp. in diabetic wound healing in Malaysia. Kelulut honey, apart from possessing similar pro-healing properties with other honey, is also found to have a better antioxidant capacity, anti-inflammatory, and free radical scavenging activity than Tualang honey. These effects are due to the much higher content of phenolic and flavonoid substances in Kelulut honey, the key bioactive factors promoting wound healing and preventing oxidative stress-related injury. Australian researchers have also recently discovered a novel source of the rare disaccharide trehalose in stingless bee's honey, which is highly anti-diabetic and antioxidating. This study aims to investigate the efficacy of honey against gel dressing for wound bed preparation among diabetic patients.