Exoskeleton devices are wearable technologies designed to assist movement and enhance mobility, often used in rehabilitation and supportive care settings. Clinical trials for these devices evaluate their safety, effectiveness, and impact on quality o...
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Found 9 Actively Recruiting clinical trials
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Researchers are studying the use of digital twin technology to improve exoskeleton control for healthy individuals. This project aims to create a virtual model that runs parallel to the users movements, calculating the torque needed at each joint to maintain stable walking without falling. This approach addresses current limitations in exoskeleton applications that focus mainly on motor torque compensation without considering overall motion stability and fall prevention. Participants will wear sensors such as inertial measurement units IMU and electromyography EMG devices on their lower limbs to non-invasively capture body signals while performing various common actions or transitions between actions. The system will analyze joint angles, angular velocity, and acceleration to predict human intent and adjust exoskeleton support accordingly. This includes warning and reducing auxiliary forces when movements fall outside a stable gait, and recognizing changes in movement modes like stopping or sitting. During the study, participants joint angles, muscle activity, and overall movement intentions will be monitored over three years. The data collected will help refine the machine learning models predicting human intent. Participation involves wearing sensors and performing movements while researchers collect and analyze body signal data. Safety and stability will be assessed continuously, with no invasive procedures involved. The study is led by National Taiwan University Hospital and allows healthy volunteers aged 18 to 80 years.
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This research aims to evaluate the safety and effectiveness of an intelligent powered exoskeleton designed to help patients regain lower limb function after spinal surgery. The study focuses on patients who have motor disorders in both legs following surgery for conditions like degeneration, tumor, or trauma. The goal is to compare different rehabilitation approaches and provide data to support future clinical studies. Participants are randomly assigned to one of two groups one group will perform rehabilitation exercises using the powered exoskeleton device, while the other group will undergo traditional rehabilitation exercises without the exoskeleton. The study is conducted at a single center and follows patients for up to 12 months to assess various outcomes. During the study, participants will undergo several tests and measurements at 3 months, including a six-minute walk test, muscle strength evaluation, walking speed tests, hip joint mobility, stride length, heart rate changes, and oxygen levels. Safety is monitored through the recording of adverse events over 12 months. This comprehensive monitoring helps researchers understand how well the exoskeleton supports recovery and its safety profile over time.
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Researchers are studying adults with lower-limb impairment following a stroke to find the best ankle-foot orthosis AFO design that can improve their health-related quality of life. This clinical trial aims to compare three different modern carbon fiber AFO options and understand how they impact walking and balance. The study will also develop prediction models based on biomechanical function linked to each AFO design to guide clinical prescriptions. Participants will try three different AFO designs in a randomized order, wearing each device for one month after receiving training. The three types of AFOs include a pre-fabricated PF device customized to the patient, a carbon-strut CS AFO molded to the affected limb, and a multifunctional articulating MA AFO with controlled ankle movement. Each participant will follow one of six sequences where they wear each AFO for four weeks, covering all three devices. During the study, participants will complete questionnaires and performance tests with each AFO. A subset will also undergo biomechanical analyses using high-speed cameras and force plates while walking and balancing with each device. Researchers will measure health-related quality of life over the four-week real-world use of each AFO. The study is expected to last until October 2027, with ongoing assessments to understand the impact of each AFO on function and quality of life.
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This research aims to evaluate the effects of training with a powered lower-limb exoskeleton on muscle strength, respiratory function, ventilator-free days within 28 days, and hospital stay length in patients who require prolonged mechanical ventilation. These patients often suffer from muscle weakness and respiratory issues due to extended bed rest, which can reduce their chances of successful ventilator weaning and prolong hospitalization. The study seeks to provide clinical evidence supporting combined rehabilitation and respiratory care for this group. Thirty patients on prolonged mechanical ventilation will be recruited and matched by gender, age, and ICU stay length. Participants will be divided into two groups one receiving standard care plus exoskeleton-assisted lower-limb training, and the other receiving standard care without the exoskeleton. The intervention will be conducted in a respiratory care center using purposive sampling. Participants will be assessed over a two-week period, including manual muscle testing to measure lower limb strength. Researchers will monitor respiratory parameters, days free from ventilator use within 28 days, and duration of hospital stay. Informed consent will be obtained prior to enrollment, and the results aim to guide clinical integration of exercise rehabilitation with respiratory care in prolonged mechanical ventilation patients.
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Researchers are evaluating the effects of three different trunk assistance exoskeleton designs on muscle fatigue, lumbar load, and comfort during repetitive lifting tasks in healthy adult men. The study aims to determine whether these exoskeletons can reduce muscle fatigue and cumulative lumbar loading. The investigation is interventional and involves healthy volunteers performing specific lifting tasks under controlled conditions. Participants will undergo five sessions an initial adjustment and practice session followed by four lifting sessions in random order. These sessions include lifting tasks performed without assistance and with each of the three exoskeletons Uplift Lite, Biolift, and Laevo Flex. During each lifting session, participants complete three blocks of 20 minutes of a box transfer task, moving a box weighing 10% of their maximal lifting strength from ground to hip-height table at a rhythm of 7 cycles per minute. Each session lasts about three hours, with 4 to 14 days of rest between sessions. Participants will be assessed for changes in spinal compression, muscular exertion perception, and maximal lifting strength before and after each lifting session. Additional measures include exoskeleton assistance, parasitic forces, movement restriction, postural instability, pressure points, discomfort, and comfort scores. The study involves detailed monitoring of physical performance and comfort during these tasks, with total participation spanning several sessions over time.
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Researchers are studying different types of ankle foot orthoses AFOs in adults who have had lower limb salvage, reconstruction, or other problems affecting limb function. The study aims to compare conventional AFOs with advanced energy-storing-and-returning AFOs to find out which type may better reduce pain and improve function for people with lower limb injuries. This research will help healthcare providers modify AFOs to make them more comfortable and useful for patients. Participants will test both AFO types during the study. Initially, each participant will be fit with the AFO category they do not usually use to ensure they try both types. Each AFO is worn for up to three weeks with training on proper use and maintenance. After these accommodation periods, participants will continue using the devices for up to one year, with monthly assessments to gather information about their experience, including physical tests, surveys, and activity monitoring. During the study, participants will complete various physical performance tests such as the Timed Up & Go, Two-minute Walk Test, and Four-Square-Step-Test after each AFO accommodation period. They will also complete balance confidence scales and patient-reported surveys monthly for a year. Researchers will collect data on device usage, failures, and participant feedback through interviews to understand preferences and outcomes. The total study participation lasts about 18 months.
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Low back pain is a widespread condition causing significant health care costs, often without a clear cause. This research evaluates whether wearing a lumbar brace after emergency department visits for benign low back pain can reduce pain, improve spine function, decrease painkiller use including opioids, and lower future health care resource use. The study is a randomized controlled trial aiming to provide emergency staff with better pain control options beyond medications. Participants with benign low back pain will be randomly assigned to either wear a semi-rigid lumbar brace for six weeks during the day along with their usual care or to continue their current back pain management without a brace. The brace is adjustable to fit various waist sizes and is designed to limit lumbar spine movement without restricting overall spinal function. Both groups will be monitored over time with data collected through questionnaires and electronic monitoring of brace use. Participants will complete self-reported surveys measuring pain and disability at baseline and at multiple follow-up points up to 12 months. A temperature and force sensor in the brace will track how long and how tightly it is worn. Text messages will be sent three times per week for four weeks to gather ongoing data about pain, function, brace use, and painkiller consumption. Researchers will also analyze health care use data from the year before and during the study to explore broader impacts. The study is designed with blinded outcome assessors and statisticians to reduce bias.
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Researchers are studying how forces inside carbon fiber custom dynamic orthoses CDOs can be reliably measured using special sensors called Loadpad and Loadsol. These devices support the foot and ankle, and understanding the forces within the orthosis, especially around the proximal cuff that wraps just below the knee, may improve future research, fitting methods, and patient guidance. The study involves three groups healthy adults using generic CDOs, individuals without peripheral neuropathy who regularly use ankle foot orthoses AFOs, and those with peripheral neuropathy who also use AFOs regularly. Participants will test different tightness levels of the proximal cuff, including self-selected tightness, loose, moderate, and tight fastening. The forces on the leg and foot will be measured using wireless sensors during activities such as sitting quietly, standing, and walking. Group 1 will experience randomized testing of the different cuff tightness, while Groups 2 and 3 will test their usual AFO tightness. The orthosis includes a carbon fiber footplate, posterior strut, and the proximal cuff. Throughout the study, participants will wear the orthoses under various conditions while researchers collect force data and have them complete questionnaires about comfort and pain. Primary measures include forces on the cuff and foot, pain levels, and comfort scores. This study runs from March 2024 through December 2026, with participants undergoing assessments at different cuff tightness levels and activity states to better understand the impact of fastening on orthosis function.
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Walking rehabilitation after a stroke is most effective within the first three months, but many patients beyond six months can still improve their walking ability. Researchers are studying a new end-effector exoskeleton robot system called HIWIN MRG-P110 to see how usable and effective it is for gait training in patients who are 6 months to 3 years post-stroke. This randomized, single-blind study will enroll 60 stroke survivors with limited walking ability to test this new device. Participants will be randomly assigned to one of two groups an active-assistive mode group, where the robot helps but encourages voluntary movement, or a fully passive mode group, where the robot moves the legs without active assistance. Both groups will receive 15 treatment sessions over 5 weeks using the HIWIN MRG-P110 device. The study will compare improvements in walking and balance as well as brain activity changes measured by functional near-infrared spectroscopy. During the study, participants will complete walking tests before treatment, immediately after the last session, and again 3 months later. Researchers will assess gait, balance, and brain function to evaluate the robots effects. Participants must attend all treatment sessions and follow-up assessments. The study lasts about 3 months, including treatment and follow-up, with careful monitoring of safety and progress throughout.