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Found 7 Actively Recruiting clinical trials

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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.

Age: 18Years +All GendersPhase Not Applicable
3 locations
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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.

Age: 18Years +All Genders
1 location
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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.

Age: 18Years +All GendersPhase Not Applicable
1 location
I

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.

Age: 18Years +All Genders
2 locations
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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.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
11 locations
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Actively Recruiting

This research focuses on patients who have experienced a cerebrovascular accident stroke and may have difficulties recognizing their own cognitive and driving abilities. The study aims to evaluate how video feedback affects patients awareness of their driving skills compared to usual recommendations. The goal is to help multidisciplinary teams make better decisions about whether patients should resume driving after a stroke. Participants are divided into two groups one group drives with on-board cameras activated to provide video feedback, and the other group drives without video feedback, following usual recommendations. After the driving session, patients in the video feedback group review and analyze four driving situations using the recorded videos, while those in the control group review the driving situations without video feedback. This comparison helps determine if video feedback improves awareness of driving difficulties. During the study, researchers assess patients awareness of their driving behavior on the day of the test. They also measure agreement between patients and professionals on the decision to return to driving, cognitive performance scores, and acceptability of the video device. Follow-up occurs at six months to observe patient outcomes. Various cognitive and attentional tests are conducted alongside self-assessment questionnaires and professional evaluations to monitor participants throughout the study.

Age: 18Years - 85YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Cerebral palsy is a common cause of childhood disability, and many affected children experience sleep disorders that are often not detected. This trial investigates whether connected tools can improve the screening process for sleep disorders in children with cerebral palsy by selecting those who need further examination with polysomnography PSG. The study aims to address delays in diagnosis caused by limited access to PSG and the associated difficulties in managing sleep problems in these children. Participants will use connected devices to monitor their childs sleep at home for one night. Then, the child will spend one night in a hospital where sleep will be recorded simultaneously using connected tools and the reference method, polysomnography. This approach compares the new connected tool method against the standard PSG to evaluate its accuracy in diagnosing sleep disorders. During the study, researchers will assess the sensitivity and specificity of the connected tool diagnosis, acceptability by parents and children, sleep quality, data quality, and cost-effectiveness of the screening method. The total observation includes short-term outcome measurement at 15 days and longer-term data collection over 25 months. Families will be involved in recording sleep data and completing questionnaires to help measure these outcomes.

Age: 6Years - 15YearsAll GendersPhase Not Applicable
6 locations