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Wounds and Injuries clinical trials

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NCT ID: NCT05811884 Not yet recruiting - Clinical trials for Spinal Cord Injuries

Patient-centered Assessment of the Effects of Powered Exoskeleton Use in People With Spinal Cord Injury

Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of the use of powered exoskeleton for ambulation on the quality of life in subjects with spinal cord injury. The main questions it aims to answer are: 1. How much does the use of powered exoskeleton improve the quality of life in subjects with spinal cord injury after a 24 months treatment period in a house context (treatment 1) or in a clinical setting (treatment 2)? 2. How much do the two treatments differ in terms of cost-utility ratio? Participants will be included in a multi-step process consisting of: 1. Recruitment, based on eligibility criteria; 2. Observation of the "stability" over time (2 months) of specific clinical parameters; 3. Training in the use of the powered exoskeleton (1 month); 4. Random selection of the rehabilitation treatment (house rehabilitation or central rehabilitation); concerning the house rehabilitation, the subject will be provided the device for home use; concerning the central rehabilitation, the subject will be asked to use intensively the device 1-week every three months in a clinical facility. 5. Follow-up: every six months each subject will be asked to attend a single-day activities session consisting of walking activities with the exoskeleton, compilation of questionnaires, sub-maximal effort test with arm-ergometer, and physical examinations made by a physiatrist.

NCT ID: NCT05810077 Not yet recruiting - Clinical trials for Brachial Plexus Injury

Feasibility of Brachial Plexus Ultrasound in Evaluation of Patients With Brachial Plexus Injuries

Start date: June 2023
Phase:
Study type: Observational

Evaluation of ultrasound as a diagnostic tool in assessment of patients with brachial plexus injuries before undergoing surgical exploration

NCT ID: NCT05799170 Not yet recruiting - Trauma Clinical Trials

Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial.

NCT ID: NCT05788146 Not yet recruiting - Stroke Clinical Trials

A Blended Psychological Intervention for Depression After Acquired Brain Injury

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

1.3 million people in the UK live with an Acquired Brain Injury (ABI) as a result of experiencing a stroke or traumatic brain injury (TBI). Up to 50% of individuals with ABI will experience depression. NICE guidelines recommend Cognitive behaviour therapy (CBT) for depression after ABI. There is growing interest into increasing access to CBT through mHealth technology, including mobile applications. Objective: Phase 1 of the study aims to investigate whether a blended psychological intervention, using a novel smartphone-based application alongside individual therapy sessions is acceptable and feasible for targeting depression after ABI. Phase 2 of the study aims to use qualitative interviews to better understand the participants' experiences of using the mobile app as part of the intervention. Methodology: The researchers aim to recruit 20 individuals with ABI, who are experiencing mild-moderate symptoms of depression. Participants will complete outcome measures and cognitive tasks at the beginning of the study. Participants will then receive a six-week blended psychological intervention; engaging the CBT-based mobile app alongside weekly, 30-minute video or telephone sessions for therapeutic and technology support. Participants will then be asked to complete the same outcome measures as completed at the beginning of the study. Participants will then be invited to take part in a 30-minute interview about their experience of using the mobile app as part of the intervention. Data Analysis: Change scores will be calculated from the data collected as part of phase 1 of the study, to investigate initial efficacy. Recruitment and dropout rates will help determine the feasibility of the blended intervention. In the 2nd phase, qualitative data will be analysed following Ritchie and Lewis (2003)'s Framework Analysis. Findings: Results from this study will help increase understanding into the acceptability and feasibility of using mHealth technology for treating depression following ABI. If effective, it could help to increase access to psychological interventions for individuals living with ABI. We hope to publish findings in a peer reviewed journal.

NCT ID: NCT05777499 Not yet recruiting - Stroke Clinical Trials

MUSic Therapy In Complex Specialist Neurorehabilitation

MUSICS
Start date: March 2023
Phase: N/A
Study type: Interventional

Aim: Investigate whether patients undergoing specialist rehabilitation after complex neurological injury show different functional outcomes if music therapy is included in their rehabilitation program compared to usual care. Background: Patients with complex needs following a brain, spinal cord, and/or peripheral nerve injury often require a period of specialist neurorehabilitation. This involves multiple therapy disciplines, led by a Consultant in Rehabilitation Medicine, Neurology, or Neuropsychiatry. Although music therapy is suggested to enhance neuroplasticity and recovery in patients with brain injury, it is not routinely commissioned in clinical care due to a lack of supportive evidence. Hypothesis: Patients undergoing music therapy in addition to complex specialist rehabilitation show better functional outcomes compared to usual care. Number of participants: 75, aged 16-80 years. Methods: Patients undergo baseline assessments and are randomised to MUSIC or CONTROL Therapy. Both arms receive 1-3 additional therapy sessions per week, matched for duration and number, total 15 hours. After approximately 10-weeks intervention, assessments are repeated. All participants then have access to music therapy until they are discharged from Neurorehabilitation Unit (NRU), with additional qualitative data collection using semi-structured interviews, field notes, staff reports, staff stress surveys, and broader ecological observations. Duration for Participants: From consent to discharge from NRU. Primary Outcome: Change in Functional Independence Measure+Functional Assessment Measure (FIM+FAM), Northwick Park Dependency Scale (NWPDS), and Barthel Activities of Daily Living pre and post 15 hours intervention. Secondary Outcome: Change in quality of life (Flourishing Scale), psychological distress (Hospital Anxiety and Depression Scale, Depression Intensity Scale Circles), social interaction (Sickness Impact Profile Social Interaction Subscale), well-being (WHO Well-Being Index), and communication (Communication Outcomes After Stroke Scale), pre and post 15 hours intervention. Mean difference in well-being (WHO Well-Being Index) throughout the intervention period between music therapy and control therapy groups. Mean difference in post-intervention pain and mood visual analogue scores between music therapy and control therapy groups.

NCT ID: NCT05771233 Not yet recruiting - Athletic Injuries Clinical Trials

Effectiveness of Abdominal Muscle Strengthening and Pelvic Control in the Prevention of Dance Injuries

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

Introduction. After observing the lack of lumbo-pelvic control and the difficulty in identifying the musculature used when performing the different dance positions, it was decided to carry out an exercise intervention to strengthen the abdominal musculature and lumbo-pelvic stabilization with dancers of the Dance Conservatory of Murcia. Approximately 40 students in the 6th year of professional dance of the 4 specialties taught will participate in this study. Objectives. To improve abdominal musculature, lumbo-pelvic stability, dance technique and proprioception, to favor the correct integration of the dancer's body scheme and muscular synergies, to reduce the risk of injury and to avoid muscular compensations in the specific Arabesque dance position. Methods. In order to develop the study, two individual and specific assessments of the dancer will be performed, pre and post intervention. In these, data and personal history were collected, assessing joint ranges and asymmetries in the movement of upper and lower limbs, and musculoskeletal assessment of the spine, hip and knee was performed by orthopedic tests. Flexibility of the ischiosural muscles will be evaluated by means of the toes-floor test and the popliteal angle test, and muscle strength in the abdominal and lumbar region for the muscles most involved in the Arabesque movement. In addition, core stability will be assessed by specific tests and hip and knee extension range along with the increase in lumbar curve when performing Arabesque. The intervention will be carried out through group sessions of 4 to 6 participants, and exercises aimed at muscle strengthening and improving lumbo-pelvic stability will be taught. The intervention will be performed 1 hour per week, with each group, for 2 months and they will be instructed to work this routine two hours per week at home.

NCT ID: NCT05762588 Not yet recruiting - Knee Injuries Clinical Trials

JuggerKnot With Broadband PMCF Study

Start date: March 31, 2023
Phase:
Study type: Observational

The purpose of the study is to collect post-market clinical follow-up data, which is needed to confirm the safety and performance of the JuggerKnot device and meet existing EU regulatory requirements.

NCT ID: NCT05752058 Not yet recruiting - Clinical trials for Liver Transplantation

Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children

Start date: August 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children .The main questions it aims to answer are what the risk factors are for early ALI in children and to evaluate the predictive value for the development of ALI.Participants will be divided into non-ALI group and ALI group according to whether they had ALI in a week after liver transplantation.Researchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ALI, and receiver operating characteristic(ROC) curve was used to evaluate the predictive efficacy of risk factors.

NCT ID: NCT05749510 Not yet recruiting - Clinical trials for Radiation-induced Intestinal Injury

Prediction of Radiation-induced Late Intestinal Injury

RLII
Start date: March 1, 2023
Phase:
Study type: Observational

Our team has constructed a prediction model based on the phase separation level of DNA repair factors (MRNIP、NONO、NOP53) to predict radiation-induced late intestinal injury (RLII) and verified the predictive efficacy of the system in retrospective studies. This clinical study intends to further prospectively verify the accuracy of this prediction model in rectal cancer patients. In this study, we plan to enroll 200 patients diagnosed with locally advanced rectal cancer by pathology and MRI, who undergo neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME). We will follow up the occurrence and progression of radiation-induced intestinal injury within 1 year after TME. Phase separation level of DNA repair factors will be detected in pathological tissue after TME and applied to the prediction model to predict RLII. Based on the clinical diagnosis of RLII, the area under curve (AUC), accuracy, precision, specificity, and sensitivity of this prediction model in predicting RLII will be evaluated. The main outcome hypothesis is that the AUC of RLII predicted by the prediction model based on the phase separation level of DNA repair factors is more than 0.8.

NCT ID: NCT05749497 Not yet recruiting - Clinical trials for Radiation-induced Intestinal Injury

Prediction of the Chronicization of Radiation-induced Acute Intestinal Injury Based on the Expression Level of lncRNA

PCRAII
Start date: March 1, 2023
Phase:
Study type: Observational

Our team has constructed a prediction model based on the expression level of lncRNA (lncRNA-UCID、NEAT1、ciRS-7) to predict the chronicization of radiation-induced acute intestinal injury (RAII) and verified the predictive efficacy of the system in retrospective studies. This clinical study intends to further prospectively verify the accuracy of this prediction model in rectal cancer patients. In this study, we plan to enroll 200 patients diagnosed with locally advanced rectal cancer by pathology and MRI, who undergo neoadjuvant chemoradiotherapy (NCRT) and total mesorectal excision (TME) and develop RAII during NCRT or within 1 month. We will follow up the occurrence and progression of radiation-induced intestinal injury within 1 year after TME. Expression levels of lncRNA will be detected in pathological tissue after TME and applied to the prediction model to predict the chronicization of RAII. Based on the clinical diagnosis of chronic radiation-induced intestinal injury, the area under curve (AUC), accuracy, precision, specificity, and sensitivity of this prediction model in predicting the chronicization of RAII will be evaluated. The main outcome hypothesis is that the AUC of chronicization of RAII predicted by the prediction model based on the expression level of lncRNA is more than 0.8.