Clinical Research Directory

Impact Study on Users of Upper Limb Assistive Devices

This impact study of upper limb (UL) assistance devices is part of the Exploratory PEPR O2R "Robotic assistance for human movements." The integrated project PI3 "ASSISTMOV," composed of a multidisciplinary team in engineering and Human and Social Sciences (HSS), targets the use case of employing robotic assistance for the movement of persons with disabilities (PWD). Through the development of a range of exoskeletons (lower and upper limbs), this project aims for a breakthrough technology enabling fluid and robust interaction with a variety of environments and uses (from rehabilitation to daily life). The proposed study contributes to this objective by exploring the clinical and psychosocial dimensions of the daily use of UL assistance devices. Through interviews and questionnaires, it aims to collect data on their impact in terms of independence in activities of daily living (ADL), satisfaction, quality of life, social participation, as well as social perceptions related to the use of these technical aids. It will make it possible to document the benefits and limitations of existing devices from the users' point of view (patients and informal and/or professional caregivers), by identifying the factors that facilitate or hinder their adoption and by exploring the care pathway, from prescription to daily use. The questionnaires will also allow examination of economic dimensions. The participants included in this study will be recruited among users already using, in their daily life, an UL movement assistance device. All will be regular users of their device, functionally integrated into their usual environment for at least two months. Only devices benefiting from CE marking, guaranteeing their compliance with European regulations, will be eligible. No equipment will be specifically provided within the framework of this research: each participant will share their experience with their own device, as it is integrated into their ADL. A preliminary literature review helped identify the main categories of UL movement assistance devices, grouped according to the following typologies: grasping gloves, mealtime aids, robotic manipulation arms, and arm supports (electric or mechanical). The purpose of the approach is both diagnostic and forward-looking. It is diagnostic in that it makes it possible to analyze current practices, real activity, and users' viewpoints, in order to identify elements likely to be improved in the recommendation and use of the devices. It is also forward-looking, since it aims to identify new opportunities, needs, or potential developments, in order to support the thinking of roboticists based on field observations.

Nursing Health Education to Improve Functionality and Quality of Life After Ischemic Stroke

This study is titled "Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke." It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place. The primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke. To achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed. Regarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls. Independent Variables: Sociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs. Health education: received vs. not received. Dependent Variables: Cognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale). Instruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)

Xingnao Kaiqiao Acupuncture vs Electroacupuncture for Post-Stroke Upper Limb Recovery

This is a single-center interventional study conducted at the Ho Chi Minh City Hospital for Orthopedics and Rehabilitation, led by investigators from the University of Medicine and Pharmacy at Ho Chi Minh City. The study aims to evaluate the effectiveness of a specific acupuncture protocol (Xingnao Kaiqiao - Brain Awakening Acupuncture) in improving upper limb motor recovery in post-ischemic stroke patients during the early rehabilitation phase. Data collection has been completed, and the study is currently being registered on ClinicalTrials.gov to ensure research transparency, ethical compliance, and to facilitate future publication. The final results and publication will be updated once the study receives a registration number.

Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia

The aim of the study is to investigate whether intensive speech-language therapy (SLT) combined with anodal transcranial direct current stimulation (tDCS) leads to better communication performance than SLT combined with placebo stimulation (using sham-tDCS).

Efficacy of Shock Wave Therapy in Post-Stroke Muscle Spasticity Management

The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are: Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does SWT improve the quality of life for these patients? What side effects, if any, occur during or after SWT? Researchers will compare SWT to conventional spasticity treatments to determine its effectiveness and potential advantages. Participants will: Undergo SWT sessions as part of their rehabilitation protocol over a period of 8 weeks. Attend follow-up visits to assess muscle tone, joint mobility, and overall functional improvement. Complete quality-of-life questionnaires to measure the therapy's impact on daily living.

Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries.

Neurological disorders \[such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)\] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life. Deterioration in motor function after stroke or BM is closely linked to the level of force produced at joint level. This is influenced by adaptations (neurological and tissue) inherent to the pathophysiology of the injury, and characterized by the presence of a spastic paresis syndrome. A great deal of effort is devoted to motor neurorehabilitation (particularly physiotherapy) in the days and weeks following neurological injury. This so-called sub-acute rehabilitation phase is designed to have a positive impact on the patient's motor recovery (to prevent the development of spastic paresis), and to prevent future severe limitations in the long term. Disorders observed in the chronic phase (partial recovery of strength, severe orthopedic deformities) demonstrate the limits of current therapies. In view of the results obtained in healthy subjects, eccentric training now seems to be one of the most promising physiotherapy methods for recovering muscle strength and countering neurological disorders. However, its use in the sub-acute rehabilitation phase has never been evaluated in post-stroke or post-BM patients, either in terms of its effects on the strength developed in the strengthened muscles, or more locally on the neurological and tissue disorders found in these patients in the context of spastic paresis. The aim of this project is to evaluate the effects of an eccentric muscle-strengthening exercise protocol on neurological patients in the sub-acute phase of their neurological impairment. The protocol will be applied to the ankle joint, given its importance for walking and the significant deficits found at this level in neurological populations.We hypothesize that the strengthening protocol will improve muscle strength at the ankle, and generate beneficial adaptations to combat the spastic paresis syndrome (improved muscle activation, increased muscle length, muscle volume, etc.).