Clinical Research Directory

Impact Evaluation of Breizh Fabribus Intervention for Personalized Assistive Technology Creation or Adaptation

In France, more than 14 million individuals report severe functional limitations, and nearly 5 million struggle with essential daily activities. Traditional barriers to assistive technology-high costs, lengthy funding delays, lack of information, and poorly fitting off-the-shelf solutions-frequently lead to underuse, dissatisfaction, and environmental waste The BFB-IMPACT study evaluates the real-world effectiveness of Breizh Fabribus, a mobile workshop equipped with 3D printing and laser-cutting that produces and customizes assistive devices on site for people with disabilities in Finistère, France region. This retrospective, single-center investigation includes all service recipients from January 2024 to December 2025 and measures changes in users' ability to perform targeted activities at three months post-intervention. Secondary outcomes include user satisfaction and device utilization. Data collection occurs from October 2025 to May 2026, with analysis anticipated in June 2026 and results published in the second half of 2026.

Predictors of Emergency Department Use in Frail Patients

When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.

Translation and Validation of the Upper and Lower Limbs, Pain, Autonomy and Quality of Life Scales in Albanian

The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing. The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimated through stability and homogeneity assessment

Repetitive Transcranial Magnetic Stimulation Primed Self-controlled Practice on Motor Learning

This study aims to investigate the additive effects of combining self-controlled practice with repetitive transcranial magnetic stimulation (rTMS) pretreatment on motivation enhancement and motor learning performance in healthy young adults. According to the "Optimizing Performance Through Intrinsic Motivation and Attention for Learning" (OPTIMAL) theory, numerous studies have demonstrated that providing learners with autonomy during practice can facilitate intrinsic motivation and motor learning. However, self-controlled practice alone may have limited effects, and further interventions may be required to amplify learning outcomes. In recent years, non-invasive brain stimulation techniques-particularly high-frequency (facilitatory) rTMS applied to the dorsolateral prefrontal cortex (DLPFC)-have been shown to enhance motivational drive and explicit learning performance by strengthening the connectivity of the DLPFC-midbrain dopamine pathway. For example, 10 Hz high-frequency stimulation can significantly improve learners' accuracy and motivation. Interestingly, several sequence learning studies have found that low-frequency (inhibitory) rTMS, when used as a priming intervention, can instead enhance implicit procedural learning. This effect may occur because inhibiting the lateral prefrontal cortex reduces its top-down suppression of implicit learning systems, thereby releasing procedural learning potential. Based on the theory of metaplasticity, applying facilitatory or inhibitory stimulation beforehand can alter the threshold of synaptic plasticity, thus influencing subsequent learning outcomes. Therefore, this study designed two DLPFC pretreatments-facilitatory and inhibitory-and combined them with self-controlled practice to systematically examine the interaction between different stimulation protocols on motivation and motor learning. This cross-sectional experiment plans to recruit 72 healthy participants aged 20 or older, randomly assigned to one of six groups: (1) facilitatory rTMS + self-controlled practice, (2) facilitatory rTMS + yoked control, (3) inhibitory rTMS + self-controlled practice, (4) inhibitory rTMS + yoked control, (5) sham rTMS + self-controlled practice, and (6) sham rTMS + yoked control. The experiment will last for seven days. On Day 1, participants will complete baseline testing, followed by facilitatory rTMS, inhibitory rTMS, or sham stimulation over the DLPFC. Immediately afterward, they will engage in a trajectory-tracking learning task (manipulating a joystick to reproduce a sine-wave pattern). After practice, participants will complete a motivation assessment. During the trajectory-tracking task, the self-controlled group can choose when to receive feedback to adjust their learning, whereas the yoked control group will receive feedback at time points matched to their paired counterpart. On Day 2, participants will again receive the assigned rTMS (facilitatory, inhibitory, or sham), complete the trajectory-tracking task, and undergo a motivation assessment. After a five-minute rest, they will perform retention and transfer tests, followed by TMS measurement of cortical excitability. On Day 7, participants will return to the laboratory to complete another retention and transfer test, along with cortical excitability measurement via TMS. The primary behavioral outcomes are the root mean square error (RMSE) and error estimation (EE) in the trajectory-tracking task. Motivation will be assessed using the Intrinsic Motivation Inventory (IMI). As there have been no prior studies combining DLPFC rTMS pretreatment with practice autonomy, the results of this experimental design are expected to provide new insights and references for enhancing motor learning ability in healthy adults.

Neurorehabilitation Through Hippotherapy of a Brain Stroke

Cerebrovascular accident \[CVA\] (medical term for stroke) is a high burden worldwide disorder and the second leading cause of disability. As illustrated by the number of survivors that remain disabled after a CVA (2 out of 3 according to the US National Stroke Association), recovery is limited, and novel neurorehabilitation approaches are urgently needed. Hippotherapy is an emerging specialized rehabilitation approach, performed by accredited health professionals on a specially trained horse via its movement. A body of scientific evidence has gradually emerged in recent years, showing robust benefits of hippotherapy in various massive neurological disabling conditions including brain stroke. The aim of the study is to analyze the effect of a hippotherapy program of several cycles delivered during 22 weeks in total, on the functional and global evolution of post-stroke patients (with a score of Rankin ≥ 3 at inclusion) during the outpatient rehabilitation phase. A second purpose is to measure the impact of the intervention on the quality of life of their close caregivers. A prospective clinical trial on the effectiveness of hippotherapy versus conventional outpatient rehabilitation alone will be carried out. The 22-weeks program includes three cycles of hippotherapy as follows: an initial 2-weeks cycle, an intermediate 1-week cycle and a final 1-week cycle. One-hour daily sessions will be conducted during each cycle exclusive additional rehabilitation care. After each cycle, the patients will have a 9-weeks rest period where they will continue their conventional therapy. A battery of clinical tests will measure both functional and psychological outcome. The primary end point will be the functional independence of the patient. The secondary end points will consider the patient's sensorimotor and cognitive function, the severity of stroke and the quality of life, as well as the caregivers' burden and quality of life. Program evaluation is important in neurorehabilitation to ensure that patients are achieving meaningful outcomes from the care. A primary question is how do stroke patients clinically evolve after being discharged from the hospital and how stable is the achieved rehabilitation outcome. Hippotherapy optimizes brain plasticity and has a strong impact on the global rehabilitation process and functional outcome of these patients. A remaining question concerns the improvement of the caregivers' quality of life.