Clinical trials

Spinal cord injuries resulting in paraplegia affect patients' mobility and, consequently, their ability to participate in activities of daily living. In France, according to available sources, the number of people with a symptomatic spinal cord injury is estimated to be between 97,000 and 132,000, with an average age of 55. The incidence is estimated at 1,300 new cases per year. Following initial treatment, patients' aim is to resume their daily activities. Engaging in these activities is associated with a better quality of life and is recognised as having a positive effect on health. Limitations in their ability to move around directly affect their participation in activities of daily living and, consequently, their quality of life. To this end, mobility can be supported by a manual wheelchair (MW) or an electric wheelchair (EW); however, these aids do not enable patients to regain the ability to stand, which remains one of the main goals for people with spinal cord injuries. Robotic exoskeletons can assist with standing and locomotion. To date, robotic exoskeletons have been used in rehabilitation centres. During the rehabilitation phase, these devices have proven to be usable and safe for a wide range of patients with spinal cord injuries. Motorised exoskeletons thus enable patients to perform tasks such as walking, standing upright, rotating, and carrying out dynamic balance exercises. In the longer term, personal exoskeletons, used at home, could facilitate the performance of productive, domestic, social or recreational activities, such as those carried out on a daily basis by every individual. Personal powered exoskeletons (PPEs) also appear to generate physiological and psychosocial benefits. Studies describe potential improvements in cardiovascular health, bladder and sphincter function, and a reduced risk of osteoporosis. After a few weeks of training with a motorised exoskeleton, patients report improvements in social functioning, mental health and sub-domains of general health perception on the SF36 Walk Wheel. It should be noted that the ability to interact socially whilst standing is an important aspect of quality of life for patients with spinal cord injuries. Patients describe the pleasure of eye contact, of being able to walk with assistance, and an improvement in mood. The PPE would complement the wheelchair by enabling ambulation and participation in activities whilst standing. Preserving upper limb function is a prerequisite for the widespread use of walking exoskeletons in everyday life. A self-supporting PPE, such as the EVE® device, which does not require the use of crutches, aims to enable users to stand up and walk whilst retaining the use of their upper limbs. This active balance control is a crucial function for achieving many functional skills in a domestic environment. One of the technological advantages of the self-balancing exoskeleton lies in the use of dynamics to eliminate the need for crutches, whilst ensuring walking safety. The next step towards the development of personal exoskeletons for people with spinal cord injuries is to investigate the performance of activities of daily living whilst wearing an exoskeleton. To our knowledge, no such study has been carried out, and our work addresses a gap in the scientific literature by analysing the impact of using a self-propelled PPE on satisfaction and performance when carrying out activities of daily living. The investigators hypothesise that the personal exoskeleton leads to greater satisfaction when carrying out the four tasks of daily living, compared with that achieved using a manual wheelchair. In this context, the KER-EXHOME clinical trial, proposed by Dr Stéphanie LEPLAIDEUR (coordinator of this study), and led by the Kerpape Centre (sponsor), aims to compare, in participants with paraplegia, satisfaction and performance when carrying out activities of daily living and physical activities, using the EVE® device compared with a manual wheelchair.

Concussion is a major concern in the sports world. It represents an immediate and transient alteration of neurological functions due to a direct or indirect trauma, with or without loss of consciousness. Concussions affect between 1.6 and 3.8 million people per year in the United States across all sports. The prevalence varies depending on the sport. In France, the incidence of sport-related concussions is estimated at 200,000 cases. According to the French Academy of Medicine (March 2025), concussions account for between 5% and 9% of all sports-related injuries. Among these cases, 30% involve individuals aged 5 to 19. Football (soccer) is one of the most affected sports, with its 2 million registered players. In French professional football (Ligue 1 and 2), during the 2023-2024 season, one concussion was recorded every 55 matches on average (declared concussion). During the 2018-2019 and 2019-2020 seasons, the rate of matches with concussion was approximately 2.5%. In professional rugby, it is estimated that one concussion occurs every three matches in France. There are no precise statistics on the number or frequency of concussions in amateur football in France, due to a lack of reporting and insufficient diagnosis. Currently, practical recommendations exist for managing football players from the moment of impact on the field, implemented within the French Football Federation. The current concussion protocol includes a standardized tool for evaluating concussion intended for healthcare professionals, the SCAT6. However, this protocol is not always sufficient, and return-to-play sometimes occurs too early. Indeed, current assessments are too brief and do not evaluate all cognitive functions. They do not allow a clear understanding of the real on-field consequences. It is estimated that 50% of athletes return to play too early after a concussion, with risks of neurological complications or prolonged symptoms. However, defining rest time and return-to-play criteria is not straightforward. In practice, return to play relies, among other things, on neuropsychological tests, whose interpretation is difficult in the absence of baseline data. The concussion protocol does not allow for an accurate determination of whether performance has normalized without this neuropsychological baseline. Recent European and international recommendations advise conducting pre-season assessments to provide comparative values. Several studies have been published on the type of pre-season assessments to perform, most using paper-and-pencil or computerized neurocognitive tests. The current concussion protocol relies mainly on paper-and-pencil tests. However, the literature shows dissociations between cognitive performance measured in ecological environments and performance measured through paper-and-pencil tests. Ecological tasks have the advantage of closely approximating the daily actions of a player and assessing cognitive functioning more precisely. Thus, these ecological tasks, combined with a baseline assessment, would improve the evaluation of athletes following a concussion. These tasks would facilitate return-to-play decisions through more objective observations and normed data. Finally, ecological tasks would enhance player monitoring and allow a more accurate understanding of their health status. For this reason, it seems necessary to develop a standardized ecological test performed in real-game situations. This would improve decision-making regarding return to play without medically endangering the player and would allow better understanding of the cognitive effects of concussion. These tasks will first be reviewed and tested by experts (players, football staff members, national concussion reference physician, and neuropsychologists) for feedback and refinement.

The objective of this project is to verify the validity and determine the clinimetric properties after translation and adaptation into French of the Trunk Impairment Scale (TIS), a scale for measuring trunk control and seated balance.

The goal of this non-interventional study is to identify patients who respond to platelet-rich plasma (PRP) injections for chronic lateral epicondylalgia (tennis elbow) and to investigate factors associated with treatment response. The study will include approximately 139 adults (18 years and older) with chronic lateral elbow pain who received a PRP injection within the last 48 hours. The main question it aims to answer is: How many patients respond to PRP treatment for chronic lateral epicondylalgia at 90 days after injection? Secondary questions include: Which clinical, demographic, and occupational factors are associated with response to PRP? Can a predictive model be developed to identify patients likely to respond to PRP? How do pain, hand grip strength, and functional outcomes evolve over 90 days in responders versus non-responders? Participants will: Attend three visits at baseline (Day 0), Day 45, and Day 90. Undergo clinical examinations, pain assessments (EVA, DN4), functional tests (hand grip, PRTEE), and questionnaires. Have data on professional activities, medical history, and treatments collected. All procedures are part of routine care, except for the addition of the Clinical Global Impression - Change (CGI-C) scale at Day 45 and Day 90 to assess treatment response. The study will be conducted at the CMRRF de Kerpape and the CHU de Rennes in France. Each participant will be followed for approximately 3 months.

The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.

Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities. This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams. The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.