Clinical Research Directory

Effects of the Stimulation Site of tsMS With TMS on Functional Mobility in Individuals With Parkinson's Disease

This randomized clinical trial aims to compare the effects of two different trans-spinal magnetic stimulation (tsMS) application sites, cervical versus thoracic, when combined with repetitive transcranial magnetic stimulation (rTMS), on functional mobility in individuals with Parkinson's disease (PD). Participants diagnosed with PD will be randomized into two intervention groups (rTMS + cervical tsMS or rTMS + thoracic tsMS) and will undergo 10 treatment sessions. Outcomes will include functional mobility, gait speed, motor function, freeing of gait, balance, quality of life, global perceived improvement and adverse events. The study is expected to identify the most effective tsMS application site to enhance mobility and motor outcomes in PD, contributing to the optimization and standardization of tsMS protocols as an adjunct therapy.

Quantifying Gait Disorders With Wearable Sensors

This is a single-centre, cross-sectional observational study with adjunctive procedure for the healthy voluteers at IRCCS Ospedale San Raffaele's Rehabilitation Department. Patients (n=50): use of inertial measurement units (IMU) and electromyographic (EMG) data routinely acquired during their standard clinical gait-rehabilitation sessions (no protocol changes; purely observational, data extracted from treatments). Healthy volunteers (n=50): age- and sex-matched volunteers who complete three 18 meters gait sessions with IMUs on trunk, thighs, shanks and feet and surface EMG on gluteus, quadriceps, hamstrings, tibialis anterior, and gastrocnemius. Healthy volunteers will be enrolled from hospital personnel, family members of the patients in visit at San Raffaele Hospital. Data \& Analysis: Kinematic (range of motion - ROM, step timing, walking speed) and EMG (activation amplitude/timing) parameters will be extracted. Between-group comparisons will employ t-tests/analysis of variance - ANOVA - (or non-parametric equivalents).

Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury

Spinal cord injury (SCI) often results in partial or complete loss of movement. In the subacute phase (\< 6 months), the central nervous system shows increased potential for neuroplasticity, making it more responsive to rehabilitation and external stimulation. Standard care in rehabilitation centers relies on activity-based therapy (ABT), which uses intensive, task-specific training to promote recovery. Although ABT can improve mobility, its effects are often limited due to the nature of SCI and the indirect activation of neural circuits. Recent findings suggest that adding transcutaneous spinal cord stimulation (tSCS) to ABT in chronic SCI (\> 12 months) can enhance lower-limb motor recovery. This study will evaluate whether combining tSCS with gait training is safe and feasible in individuals with subacute SCI and whether it improves lower-limb motor outcomes compared with gait training alone. The investigators hypothesize that pairing gait training with tSCS early after injury will be safe and feasible and that tSCS delivered during gait training will augment leg muscle activation and lead to greater functional improvements. The study will also assess the feasibility, safety and tolerability of implementing this combined intervention in a intensive functional rehabilitation setting.

Walking Function Outcomes Following Surgical Correction With Rehabilitation Versus Physical Therapy Alone in Charcot-Marie-Tooth Disease: A Bidirectional Cohort Study

The goal of this study is to compare changes in walking ability in people with Charcot-Marie-Tooth disease (CMT) who receive two different treatment approaches for foot deformities that affect walking. CMT is an inherited nerve condition that can cause muscle weakness, loss of sensation, and foot deformities. These changes often make walking difficult and can reduce independence and quality of life. Treatment options commonly include physical therapy alone or surgery to correct foot alignment followed by rehabilitation. However, it is not clear whether one approach leads to better long-term walking outcomes. The main question this study aims to answer is whether individuals who undergo functional foot surgery followed by rehabilitation experience different changes in walking ability over time compared with those who receive structured physical therapy alone. Researchers will compare walking performance between these two treatment groups over a period of up to two years. Walking ability will be evaluated using standardized walking tests and patient questionnaires. Participants included in this study are individuals with CMT-related foot deformities that affect walking and who received either surgery followed by rehabilitation or physical therapy alone. Researchers will analyze changes in walking ability over time and determine how many participants achieve meaningful improvement. The findings from this study may help clinicians and individuals with CMT better understand how different treatment strategies influence walking function over time.

Effect of Mental Arithmetic Priming on Gait and Balance in Stroke

This study investigates the effect of cognitive priming through mental arithmetic on functional mobility in post-stroke patients. It hypothesizes that performing mental calculations (addition, subtraction, multiplication) prior to movement stimulates frontoparietal networks, thereby improving gait speed and dynamic balance compared to a passive control condition.

Effects of Transcranial Direct Current Stimulation Combined With Nordic Walking on Gait and Balance in Parkinson's Disease

Parkinson's disease can cause slow or unsteady walking and balance problems that raise the risk of falls. This study will test whether adding a gentle, non-invasive brain stimulation called transcranial direct current stimulation (tDCS) during a supervised Nordic Walking program improves mobility in people with Parkinson's disease. Participants will be randomly assigned to receive either active tDCS or an inactive (sham) procedure that feels the same but does not deliver current, while both groups complete the same supervised walking program. Sessions occur three times per week for four weeks. We will measure walking speed with a 10-Meter Walk Test as the main outcome, and also evaluate balance, motor symptoms, quality of life, and any side effects. We expect that tDCS given during the walking sessions will help people walk faster and feel steadier compared with the walking program alone.

The Relationship Between Self-Awareness and Risk of Falls During Walking in Adults

This study examines the relationship between self-awareness and the risk of falls during walking in older adults and rehabilitation patients. Falls are a major health concern among older adults worldwide. Many studies have shown that executive functions, such as attention and problem-solving, are related to fall risk; however, little is known about the role of self-awareness-the ability to recognize one's own strengths, limitations, and errors-in predicting falls. In this study, approximately 100 participants (adults aged 60-85 years) will be recruited from both a rehabilitation day center and community settings. Participants will complete cognitive tests, self-awareness questionnaires, and walking assessments using wearable sensors. Walking will be tested both at a normal pace and while performing a secondary task (dual-task walking). The results will help clarify whether reduced self-awareness is an independent risk factor for falls. Findings may improve fall-prevention strategies in both rehabilitation and community settings. The study protocol has been reviewed and approved by the Faculty Ethics Committee, University of Haifa, and the Helsinki Committee of Clalit Health Services.

Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture

With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.

Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems

The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground. Researchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study. During the study participants will be asked to do the following: * Answer questions about their medical history and balance. * Do some standing and walking tests. Some of the tests will be timed. * Attend study visits and participate in study phone calls. * Keep track of any falls and notify study staff if they fall. * Wear the Walkasins device on a regular basis.

The Effect of Balance-focused Exercise Programme in Enhancing the Solus-muscle Activation During Gait Initiation for People With Parkinson Disease

Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired. The purpose of this study is determining effectiveness of comprehensive, balanced-focused exercise programme in controlling the activation of Solus-muscle in people with Parkinson disease. We hypothesise that balance-focus exercise programe could improve Solus-muscle activation during GI. study type: this is a parallel group prospective (10 weeks) randomised single-blinded controlled trial conduct in Kuwait. Participant: People with Parkinson, who met the inclusion criteria.

Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders

Aging is a global trend, and consequently, the prevalence of age-related diseases is increasing. Gait disorders are common among the elderly and can result not only from various underlying conditions affecting gait but also from the decline in physiological and neurological functions associated with the normal aging process. Gait is a fundamental daily activity that requires the coordinated integration of the central and peripheral nervous systems, as well as the musculoskeletal system. Therefore, impairments in any of these systems-including the nervous, cardiovascular, respiratory, or musculoskeletal systems-can lead to gait dysfunction. Gait disorders negatively impact quality of life by increasing the risk of falls, reducing the ability to perform activities of daily living (ADLs), and limiting physical activity. Accordingly, various approaches to maintaining and improving gait function in older adults are being actively explored. Currently, gait aids such as canes and walkers are commonly used to support individuals with gait impairments. These devices help redistribute body weight by providing a broader base of support, thereby assisting with balance and stability. However, they do not directly facilitate the movement of the lower limbs. To enhance gait function, numerous studies have investigated repetitive lower-limb movement training using bicycles or robotic devices. However, the extent of functional improvement resulting from such training remains unclear, and the long-term efficacy is still uncertain. Recent advancements in sensing technology for joint motion and actuator efficiency have led to the development of wearable assistive devices that are significantly more compact and lightweight compared to conventional robotic systems. This study aims to evaluate the effectiveness of a newly developed electrically powered orthopedic exercise device in patients with gait disorders by assessing changes in gait parameters upon wearing the device, thereby exploring its clinical feasibility.

The Effects of the Control Strategies of Wearable Lower Limb Rehabilitation Robots

Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.

2D Video Gait Analysis Platform Applying to AI Model for Adjustment of the Shoes' Sole

Artificial intelligence (AI) technology makes gait analysis based on two-dimensional images feasible. The first aim of this study is to develop an analysis platform that uses two-dimensional image analysis technology to determine the relative excursion of body segments and limbs in gait. The second aim is to apply this analysis platform to develop an artificial intelligence model for customized shoe adjustment to optimize gait. For the methodology, OpenPose will be used as the analysis tool to quantify the relative shifts between specific joint/node trajectories of the body, and the VICON three-dimensional motion analysis system will be used to verify the acquisition parameters. For the second aim, an existing 2D gait image database before customized shoe adjustment will be used to obtain the inputs to the customized shoe adjustment AI model. Through training the AI model, enabling to generate the outputs of the most appropriate adjustment parameters for shoe soles. After the AI model has well-trained, the walking kinematics and foot pressure before and after wearing ordinary sports shoes or customized shoes will be compared during running on a treadmill. This research is expected to establish an efficient customized shoe adjustment AI model, allowing users to improve walking efficiency.

Study of the Link Between Freezing of Gait and Oropharyngeal Freezing in Parkinson's Patients

Parkinson's Disease: Study of the Link Between Gait Freezing and Oropharyngeal Freezing Parkinson's disease is the second most common neurodegenerative disorder worldwide. Parkinsonian dysphagia is a frequently encountered disorder in this condition, affecting all phases of swallowing: oral, pharyngeal, and esophageal. This dysphagia can occur at any stage of the disease. While most swallowing difficulties develop in the advanced stages of Parkinson's disease, they can also appear early on and are often underdiagnosed. The prevalence of swallowing disorders in Parkinson's disease is estimated to range from 40% to 80%, with this variability explained by the significant differences in the precision of swallowing evaluations conducted and the fact that dysphagia is still too frequently underdiagnosed. Yet, dysphagia is the leading cause of mortality in Parkinson's patients. Dysphagia can negatively affect patients' quality of life. It leads to difficulties during oral intake (food, liquids, and medications), weight loss, dehydration, malnutrition, and limitations in social activities. Depression is frequently associated with reduced quality of life in Parkinson's patients with swallowing disorders. Moreover, aspiration pneumonia due to mis-swallowing is one of the primary reasons for hospitalization in Parkinson's patients, potentially leading to severe complications and, at times, death. Oropharyngeal freezing, also called oral festination, is an involuntary, repetitive anteroposterior movement of the tongue against the soft palate performed before transferring the food bolus to the pharynx. This movement is also observed during multiple swallows. This phenomenon is more frequent in dysphagic Parkinson's patients, yet its impact on swallowing dynamics remains poorly understood. Oropharyngeal freezing has been observed in approximately 40% to 75% of Parkinson's patients during videofluoroscopic swallow studies, also known as swallowing pharyngography. Oropharyngeal freezing inhibits the initiation of swallowing, keeping the airway open and leading to tracheal aspiration of residues. Some fragments then slide into the valleculae and pyriform sinuses. Thus, oropharyngeal freezing exacerbates pharyngeal phase incoordination, increasing the risk of aspiration pneumonia. Therefore, addressing this swallowing disorder is essential. Oropharyngeal freezing is intrinsically rhythmic. While limited studies have been conducted on the topic, they agree that gait freezing (difficulty initiating walking, stopping in response to obstacles, or circumventing them) and oropharyngeal freezing share common pathophysiological mechanisms. Gait freezing is not limited to deficits in the locomotor network but is part of a broader deficit affecting spatiotemporal coordination in various tasks, similar to oropharyngeal freezing. It is, therefore, crucial to detect this oral phase swallowing disorder as early as possible, enabling tailored early intervention that helps patients maintain their swallowing abilities for as long as possible and prevents complications mentioned earlier. Since gait freezing is diagnosed much earlier and more systematically, it would be interesting to investigate whether there is a correlation between the presence of gait freezing and oropharyngeal freezing in these patients. This could guide patients with gait freezing toward early speech-language assessments to evaluate the presence of oropharyngeal freezing. The objectives of the study are examine the prevalence of oropharyngeal freezing in Parkinson's patients. Based on the results obtained from the NFOG-Q (New Freezing of Gait Questionnaire), two groups will be formed: The first group will consist of patients exhibiting gait freezing. The second group will consist of patients without gait freezing. The secondary objectives of the study are examine the common characteristics between these two types of freezing (gait and oropharyngeal). To assess the sensitivity and reliability of the NFOG-Q in detecting oropharyngeal freezing.To determine the prevalence of oropharyngeal freezing based on the score obtained on the UPDRS (Unified Parkinson's Disease Rating Scale). To analyze the link between patients' rhythmic abilities and the presence or absence of one or both types of freezing.

Effects of Biofeedback Footwear in Parkinson's Disease: Assessment of Functional Motor Abilities and Locomotion

The study aims to verify whether the use of a specific footwear providing increased plantar feedback (plantar feedback shoes) could improve gait parameters, postural control and functional performances in people with Parkinson's disease. Specifically, the aims are: * To evaluate the acute effect of plantar feedback shoes, by comparing gait, functional and postural performances in three conditions: neutral shoes, barefoot, and plantar feedback shoes; * To evaluate the effect of four weeks of plantar feedback shoes, on gait, functional and postural performances. Participants will undergo a comprehensive neurological examination, with administration of disease-specific scales (UPDRS III part 3, NFOG-q, LEDD, DASS-21). At each assessment the participants will perform an inertial gait analysis, a static posturography, and will undergo functional capacity assessments (TUG, 2MWT, 5-STST, 10- mFW).