Saint Genis Laval

Stroke often causes significant motor disabilities, especially hemiplegia, and its occurrence is rising with an aging population. Although some spontaneous recovery happens in the first three months after a stroke, 80% of patients still have motor deficits after six months, making intensive rehabilitation essential. Unfortunately, after hospital discharge, access to such rehabilitation is limited by factors like location, mobility challenges, and lack of insurance coverage for private therapy. This research evaluates a 12-week home-based telerehabilitation program using the MindMotion GO device, designed to supplement standard care with an additional 300 minutes of active therapy weekly. Patients participate in one weekly live session with a therapist, either in clinic or via videoconference, and complete other personalized sessions independently at home. The device offers interactive games tailored for neurological injury recovery, and the program blends remote monitoring and planning by therapists to support patient progress. Participants will be monitored over 44 weeks, with assessments at baseline and weeks 8, 20, 32, and 44 measuring changes in the Goal Attainment Scale (GAS) score. The study integrates smoothly into post-stroke care, helping patients transition from hospital to home without extending hospital stays or increasing in-person visits. Researchers will collect data on therapy adherence, motor function improvement, and overall feasibility of this telerehabilitation approach for sub-acute and chronic stroke patients.

Researchers are evaluating how using a lightweight robotic lower limb exoskeleton at home affects the quality of life for people with multiple sclerosis who have walking difficulties. This study is a multicenter, controlled, randomized, cross-over, open-label clinical investigation involving patients with an Expanded Disability Status Scale (EDSS) score between 5 and 6.5 who live at home and use assistive devices for walking. The main goal is to compare the quality of life changes between using the exoskeleton and receiving advice on physical activity. Participants are divided into two groups: one group uses the Keeogo exoskeleton for eight weeks at home during the experimental phase, following a five-day training program to become familiar with the device. After this, they use it as much as possible indoors and outdoors for seven weeks. The other group spends eight weeks in a control phase where they stay at home and follow advice for regular physical activity suited to their abilities. The study includes a wash-out period of eight weeks between the two phases, and after completing both phases, all participants have a three-month follow-up. Participants will be monitored through a questionnaire assessing quality of life changes between the screening visit and the end of each experimental phase (week 8 for one group and week 24 for the other). Researchers will collect data on how well participants adapt to and use the device, along with safety and functional assessments. The total study duration includes training, experimental and control phases, and follow-up to understand the impact of the exoskeleton on daily life and walking ability.

Researchers are evaluating the effects of a local vibration program applied to the dorsiflexor muscles on neuromotor recovery in patients undergoing subacute rehabilitation after a stroke. The study aims to determine if adding vibration therapy to a standard rehabilitation program improves walking speed compared to rehabilitation alone. The trial focuses on patients who have experienced ischemic or hemorrhagic strokes and are in the early recovery phase between 14 days and 3 months post-stroke. Participants will be randomly assigned to one of two groups: an experimental group receiving effective local vibrations at 100Hz on the paretic limb's dorsiflexor muscles, and a control group receiving sham vibration without actual vibration. Both groups will undergo 40 sessions over 8 weeks, with 5 sessions per week during hospitalization. The study includes various assessments such as the 10 meters Walk Test and 2 Minute Walk Test to measure walking speed, as well as evaluations of motor skills, muscle tone, autonomy, neuromuscular fatigue, and gait analysis. Throughout the study, participants will complete multiple tests and questionnaires including the Fugl-Meyer assessment, Modified Ashworth scale, ABILOCO questionnaire, Barthel index, electromyograms, and gait kinematics analysis. Researchers will monitor gait speed primarily at 2 months and collect data on muscle strength, fatigue, and functional autonomy. The total participation lasts for the 8-week intervention period with ongoing evaluations to assess recovery progress and safety.

Going back home after a stroke is an important step for patients and their families, who must quickly adjust to new health challenges and caregiving roles. This study evaluates whether individual peer support, provided by patient-partners with experience of stroke, can improve quality of life and patient empowerment during the discharge period compared to usual care. The research uses a mixed methods pilot design focused on stroke patients returning home from rehabilitation centers. The intervention involves psycho-social support by a peer-helper to both the patient and their main informal caregiver. This support is based on social learning and social support theories and includes a meeting before discharge followed by regular follow-ups over six months. These follow-ups can be face-to-face, virtual, or by phone, tailored to the patient's and caregiver's needs and linked to existing healthcare and social services. Participants will be involved for six months during which feasibility of the peer support intervention will be measured. The study will assess how well the support meets patients' needs and its impact on quality of life. Patients' functional status, social environment, and ability to engage in the intervention will be considered, with ongoing monitoring to ensure safety and compliance.

Researchers are investigating treatments for spastic foot in adults who have experienced a stroke, a condition that affects many patients and can lead to disabilities such as difficulty walking and maintaining balance. This study compares two treatments, Tibial Nerve Selective Neurotomy (STN) and Botulinum Toxin injections (BoNT-A), to determine which is more effective in reducing calf muscle spasticity and improving personal goals related to balance, walking, self-care, and quality of life. The research is a multi-center randomized controlled trial and aims to update guidelines for managing lower-limb spasticity in hemiplegic patients. Participants are randomly assigned to either the STN group, where they undergo surgery targeting specific muscles identified before the procedure, or the BoNT group, where injections of botulinum toxin are administered to the affected muscles using guidance techniques such as electromyography or ultrasound. Surgery is scheduled within three months after inclusion and lasts about 1 hour and 30 minutes. For the injection group, treatments respect a minimum interval of three months after the last injection. During the study, participants will be assessed using Goal Attainment Scaling to measure progress on personal goals over 14 months. Researchers will monitor changes in muscle spasticity, balance, walking ability, pain, and quality of life. The study involves various evaluations and follow-ups to ensure safety and effectiveness, with the total duration including pre-treatment visits, treatment, and monitoring through study completion.

Researchers are evaluating the EXOPULSE Suit, a medical device designed to improve walking ability in people with Multiple Sclerosis (MS) who have an Expanded Disability Status Scale (EDSS) score between 4 and 6. This device uses electrical stimulation to relax tense and spastic muscles, potentially enhancing mobility and balance. The study aims to confirm the benefits of the EXOPULSE Suit compared to a sham condition, especially for individuals who cannot use Fampridine, the only drug approved to improve walking in MS, due to contraindications or side effects. Participants will use the EXOPULSE Suit at home, worn as a non-invasive body garment with 50 electrodes that stimulate up to 43 major muscle groups. The device will be used for one hour every other day. The study involves two modes of the device: the Active mode, which stimulates muscles throughout the 60-minute session, and the Sham mode, which only stimulates during the first minute and then turns off for the remaining time. This randomized controlled crossover trial will compare walking ability between these two modes. During the study, participants' walking ability will be assessed using the Multiple Sclerosis Walking Scale 12 over 28 days. Researchers will monitor muscle spasticity, walking stability, and the participant's ability to use the device and smartphone app at home. Safety and adherence will be checked through medical visits and questionnaires. Participants will be followed throughout the study to evaluate improvements and the device's impact on daily activities and mobility.

Researchers are evaluating KRT-232, a new oral drug that inhibits MDM2, for patients with Philadelphia chromosome-positive (Ph+) Chronic Myeloid Leukemia (CML) who have relapsed, are resistant, or cannot tolerate Tyrosine Kinase Inhibitors (TKIs). This global open-label study includes Phase 1b and Phase 2 parts and aims to determine the safety and effectiveness of KRT-232 in chronic phase CML (CML-CP) and accelerated phase CML (CML-AP) patients who have not responded to prior TKI treatments. Participants receive KRT-232 combined with a TKI such as Dasatinib or Nilotinib, both taken by mouth. The study has different arms: Phase 1b focuses on finding the maximum tolerated or administered dose of KRT-232 over 28 days. In Phase 2, Arms A and B assess the major molecular response rate over 6 months, while Arm C measures the major hematological response rate during the same period. Treatments are given orally and monitored for safety and effectiveness. During the study, participants undergo regular medical assessments, including blood tests to evaluate response and safety. Researchers track how well the leukemia responds to the treatment and monitor side effects. The study follows patients closely for at least 6 months to measure key outcomes such as response rates and dose tolerance, aiming to better understand KRT-232's potential when combined with TKIs in this patient group.

This research focuses on adults aged 18 to 60 who have experienced the rare and serious condition of double amputation of both forearms. It evaluates and compares two treatment strategies: bilateral allograft (transplant) of the hands and forearms versus the use of prosthetic forehands. The aim is to assess these options in terms of costs, quality of life, usefulness, satisfaction, autonomy, and social integration, building on previous findings that hand transplants can restore autonomy but require immunosuppressive treatment. Participants may receive either a bilateral allograft of the hands and forearms or prosthetic forehands. The transplant group must meet specific health criteria, such as having had their amputation at least three months prior and no severe psychiatric or uncontrolled medical conditions. The study compares the two approaches, considering both medical and economic outcomes over time. During the study, researchers will monitor costs and other important outcomes over 36 months. They will assess autonomy, quality of life, and social integration, along with medical complications related to treatments. The study builds on earlier results showing that hand transplants can help patients regain function and return to work, despite the need for ongoing immunosuppression and possible risks. This evaluation will help guide treatment choices for patients with bilateral upper limb amputations.

Researchers are studying patients with post-acute COVID-19 syndrome, commonly known as long-COVID, to identify different clinical profiles and connect these with immune and molecular data. The goal is to find biomarkers that can predict outcomes and discover possible targets for treatment. This observational study collects detailed biological and clinical information without administering any treatments. Participants will have a one-time blood sample of 30 mL taken during their initial visit for analysis as part of the research program. No medications or therapeutic interventions are given, and samples are used immediately for immunological and molecular study without being stored. The study focuses on patients entering a multidisciplinary care pathway for post-COVID syndromes. During the study, researchers measure participants' clinical features and immunological markers at the time of inclusion. The primary outcome is the classification of participants into clinical clusters based on various clinical and laboratory variables at day 0. Participants are monitored through this single inclusion visit, and no long-term intervention or follow-up is described. The study includes adults who have persistent or complex symptoms following COVID-19 infection lasting over four weeks or more than three months.

Researchers are evaluating whether applying repetitive somatosensory stimulation (RSS) to one hand can temporarily improve tactile perception in the other hand for patients who have sensory impairments in their hand caused by stroke. The study focuses on adults aged 30 to 80 years who have experienced either ischemic or hemorrhagic stroke at least three months prior and have varying degrees of sensory loss in the hand opposite the stroke. The main goal is to compare the effects of real RSS stimulation to a sham stimulation strategy in improving tactile acuity. Participants will receive tactile stimuli on the index finger of their intact hand. One group will receive 45 minutes of continuous RSS stimulation, while the other group will receive a sham stimulation consisting of brief tactile stimuli totaling 4 minutes spread over 45 minutes in six blocks of 40 seconds each. These procedures aim to assess whether the treatment can enhance sensory function in the affected hand. The study does not include any drug treatments and focuses solely on these tactile stimulation methods. During the study, the tactile acuity of the affected hand will be measured immediately after the stimulation using tests such as the two-point discrimination test and the absolute threshold detection test. Participants will be assessed for their sensory function changes and monitored for any difficulties in maintaining hand position due to spasticity. The total participation duration and follow-up details are not specified, but the assessments focus on the immediate effects after the 45-minute stimulation period.