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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the impact of the SAM Ergonom light SAM device on helping individuals who cannot transfer independently from lying down to sitting at the edge of a bed. This randomized, crossover, multi-center, open-label study compares the SAM device to an over bed pole hoist for improving transfer independence. The study focuses on participants who require assistance to transfer and aims to support reimbursement decisions for the SAM device. Participants will use both devices in two separate phases, each lasting 7 days. In Phase A, they will use the experimental SAM device, which is a removable structure fixed to the bed frame with a handle to assist sitting up. In Phase B, they will use the control device, an over bed pole hoist. The order of device use depends on randomization one group starts with the SAM device followed by the control device, and the other group uses the devices in the reverse order. During the study, therapists will directly observe participants to measure transfer independence using the Functional Independence Measure FIM at days 7 and 14. Secondary assessments include quality of life, satisfaction with the devices, device acceptability, overall independence, effort during transfers measured by duration, and the number and quality of lifts detected by bed sensors. The study involves in-patient participants using medical beds, with various evaluations conducted at the end of each 7-day device use period.
Actively Recruiting
Researchers are studying adults with chronic lateral epicondylalgia, also known as tennis elbow, to understand how patients respond to platelet-rich plasma PRP injections. This observational study aims to find out how many patients show improvement 90 days after receiving PRP treatment and to explore clinical, demographic, and work-related factors linked to treatment response. The study also seeks to develop a model that can predict which patients are likely to benefit from PRP. Participants will have already received a PRP injection within the past 48 hours before joining the study. They will attend three visits at the start Day 0, Day 45, and Day 90. During these visits, they will undergo clinical exams, pain assessments using scales like EVA and DN4, hand grip strength tests, and complete questionnaires such as the PRTEE. The Clinical Global Impression - Change CGI-C scale will be used at Days 45 and 90 to evaluate how they respond to treatment. Most procedures are part of routine care except for the additional CGI-C assessments. Throughout the approximately three-month follow-up, researchers will collect information on participants professional activities, medical history, and treatments. They will monitor pain levels, hand strength, and functional abilities over time. The main outcome measure is treatment response at 90 days post-injection. Secondary outcomes include identifying factors predicting response and tracking changes in clinical and functional status from baseline to Day 90.
Actively Recruiting
Researchers are evaluating the use of compression garments to reduce neuropathic pain in people with Complex Regional Pain Syndrome CRPS of the upper limbs. This condition can involve pain and swelling, and while compression garments are used to reduce swelling, their effect on neuropathic pain is not well established. The study aims to explore whether wearing these garments can notably reduce pain, based on clinical experience and patient reports. Participants will receive usual care in day hospitals, consisting of three occupational therapy sessions per week for three months. One group will also wear compression garments during this period, while the other group will receive the same care without compression garments. The therapy includes desensitization using devices such as Aquaroll and Vibralgic. Follow-up visits will occur at six months and one year to continue assessments. During the study, pain will be measured weekly using a Visual Analog Scale VAS over three months, along with monitoring the tolerance and adherence to wearing the compression garments. Additional evaluations include range of motion, muscle strength, sensitivity tests, anxiety and depression assessments, quality of life surveys, and pain questionnaires. Researchers will track changes in medication, hand circumference, and disability scores. The total participation time includes the initial three-month treatment period plus follow-ups at six months and one year.
Actively Recruiting
Researchers are evaluating the impact of upper limb assistance devices used by people with disabilities, focusing on both clinical and psychosocial aspects. This study is part of a broader project developing robotic exoskeletons for upper and lower limbs to improve interaction with various environments, from rehabilitation to daily life. It aims to understand how these devices affect users independence, satisfaction, quality of life, social participation, and economic factors. Participants are regular users of CE-marked upper limb assistance devices, including types such as grasping gloves, mealtime aids, robotic arms, and arm supports. The study collects information through interviews and questionnaires about users experiences and caregivers perspectives. No new devices are provided participants share their experiences with their own devices as integrated into their daily routines. During the study, participants complete questionnaires and semi-structured interviews to assess psychosocial impact, satisfaction, quality of life, caregiver burden, and economic considerations. Data collection occurs from enrollment Day 0 through a clinical evaluation phase lasting up to 60 days. The study includes both patient-users and caregiver-users, with assessments conducted via videoconference. The overall participation duration varies but focuses on capturing real-life use and effects of the devices.
Actively Recruiting
This research focuses on adults with bilateral traumatic amputation of both forearms, a rare condition that greatly affects independence and quality of life. The study evaluates two approaches bilateral hand and forearm allografts transplants and the use of prosthetic forehands. It aims to compare these options in terms of costs, quality of life, usefulness, satisfaction, autonomy, and social integration. The study builds on previous work that demonstrated the feasibility and functional benefits of bilateral hand grafts, despite the need for immunosuppressive treatment and potential medical complications. Participants receive either a bilateral allograft of the hands and forearms or prosthetic forehands. The transplant group must meet specific medical and psychological criteria, including a minimum of three months since amputation and no recent cancer history. The prosthetic group uses prosthetic devices for limb replacement. This non-randomized study conducted by Hospices Civils de Lyon compares these two treatment approaches over a 36-month period. During the study, researchers will monitor treatment costs over 36 months as the primary outcome. Participants will be assessed for quality of life, autonomy, satisfaction, and social integration. Medical evaluations include psychological assessments, kidney function, heart function, and blood pressure control for the transplant group. The study runs until October 2031, and participants will be regularly evaluated to understand the long-term impact and benefits of each treatment option.
Actively Recruiting
Researchers are conducting a study to translate and adapt the Trunk Impairment Scale TIS into French and to verify its validity and reliability for measuring trunk control and seated balance, especially in patients who have experienced a stroke or transient ischemic attack. This study involves two main phases translation and adaptation of the scale, followed by a metrological study to assess its measurement properties. Maintaining evaluator blindness regarding patient function is an important part of the study design. The first phase includes translating and back-translating the TIS, validating the structure of the French version, and conducting cognitive interviews to ensure understanding. The second phase is a cross-sectional study at a single center where patients will be evaluated using the TIS on two consecutive days by different therapists to assess reliability and validity. This process helps confirm that the adapted tool measures trunk impairment accurately and consistently. Participants will undergo assessments involving the TIS performed by multiple evaluators to ensure unbiased results. Evaluations will include tests of content validity, reliability, internal consistency, measurement errors, and validity through various metrics over up to 21 months. The study team will monitor data such as intra- and inter-examiner reliability, convergent validity, and known-groups discrimination. Overall participation spans from initial translation validation up to long-term measurement analysis.
Actively Recruiting
Researchers are evaluating a new method to screen for sleep disorders in children aged 6 to 15 years with cerebral palsy, a condition that is the most common cause of child disability. Many children with cerebral palsy suffer from sleep disorders, which often go undiagnosed due to limited access to the standard diagnostic test called polysomnography. This study aims to assess whether connected tools can help identify children who need further sleep disorder evaluation more efficiently. The study involves children recording their sleep at home for one night using connected devices. After this, the child will spend one night in a hospital where sleep will be recorded both by the connected tools and standard polysomnography simultaneously. This approach will help compare the connected tools to the standard exam to see if the new method can accurately screen for sleep disorders. Participants will be involved for about 15 days to complete the primary outcome assessments, which include measuring the accuracy sensitivity and specificity of the sleep disorder diagnosis. Parents and children will also provide feedback on how acceptable the connected tools are. Additional evaluations involve quality of sleep questionnaires and a cost analysis over 25 months. The study tracks data quality and quality of life related to the screening method during this period.