Clinical Research Directory

Professional Impact of Osteoarticular Trauma

This study aims to describe the medical, social, and organizational determinants of returning to work after an osteoarticular injury, particularly limb fractures. Using observational data, the study will evaluate the modalities of returning to work within 12 months of the injury and analyze the factors influencing professional reintegration, including the severity of the injury, functional recovery, pain, professional characteristics, workplace accommodations, and administrative support measures such as recognition of disabled worker status. The study will also explore the point at which the issue of returning to work is first raised with the patient during hospitalization, a period during which professional reintegration is often insufficiently anticipated. By identifying current practices and breaking points, this study aims to improve understanding of the pathways to returning to work in the context of the healthcare system and the world of work in France.

Precision Medicine for Nociception, Sngception and Proprioception.

Precision medicine is defined as "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person" by the Precision Medicine Initiative. Patients have different response to different treatment modalities, and sore/pain medicine is no exception. In our experience, low-level laser (LLL), ultrasound, and prolotherapy can reduce sore /pain through different genetic pathway. Whether the therapeutic effect is controlled by the genetic variants of those sore /pain related genes or not, is still in debate. The aims of this study are (1) To set up next generation sequencing (NGS)-based approach to find genetic variants which can determine the response of sng/pain treatment modalities and the phenotype of idiopathic scoliosis. (2) To find possible metabolomics and proteomic markers of sng/pain. (3) To determine the algorithm of precision medicine for sng/pain control via the genetic markers. Investigators will recruit 80 myofascial pain participant and 80 idiopathic scoliosis participant from Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Bei-Hu Branch in 2023 and 2025. The myofascial pain participant participants will receive LLL, ultrasound, and prolotherapy, and the therapeutic effect will be recorded. The clinical trial will evaluate the Sng / pain (VAS) and muscle tone of the idiopathic scoliosis participant. The blood and urine samples from the first, the second, and the third visits will be analyzed by next generation sequencing, and mass spectrometry to find the possible biomarker in 2024 and 2025. Investigators expect to develop the individualized treatment plan by means of these biomarkers. Hopefully, the results will be widely applied in the field of sore /pain medicine.

EFFECTIVENESS AND CLINICAL OPTIMIZATION OF A STANDARDIZED PHYSIOTHERAPY EXERCISE PROGRAM TARGETING BALANCE-POSTURE INTERACTION AND FALL RISK IN OSTEOPOROSIS: A RANDOMIZED CONTROLLED TRIAL

Osteoporosis is a systemic disorder of the skeletal system characterized by decreased Bone Mass and deterioration of the Microarchitecture, making it significantly easier to fracture the bones. In addition to the increased risk of fracture due to reduced Bone Strength, other common impairments in the balance, postural control and coordination of muscles may increase the risk of falling, as well. Recent research has increasingly begun to conceptually link fall risk to be a multi-factorial issue, due to the interaction of the biomechanical, neuromuscular and functional deficits that an older person most likely experiences in conjunction with the effects of ageing (Papalia et al., 2020). As such, physiotherapy techniques for treating persons at risk of falling have progressed away from providing isolated (and consequently limited) gains in strength or mobility, towards providing a more multi-faceted and thus comprehensive, integrated method of enhancing overall physical performance through exercise. Physical activity interventions are being used to treat the condition of osteoporosis and have been identified as an essential component of preventing osteoporosis. Many recent statements have indicated that through the incorporation of organized physical activity into each individual's physical activity routine, as opposed to the previous recommendation for just resistance training and balance activities, the ability for individuals to experience a change in their physical abilities and thereby decrease their risk of falling is significantly improved (Brooke-Wavell et al., 2022; Bae et al., 2023). Among the many types of exercise-based interventions for treating osteoporosis, those that focus on improving balance have been shown to be effective in improving stability of the body postural position as well as decreasing the fear of falling (which can contribute to decreased mobility and increase the risk of falling) (Wei et al., 2023). A systematic review and analysis of the available literature indicates that targeted balance training is effective for improving both static and dynamic postural stability among older adults and persons with osteoporosis; moderate effects were found with regard to the risk of falling as a result of balance training (Zhou et al., 2018; Papalia et al., 2020). Randomized controlled trials provide additional evidence of the positive impact of physiotherapy programs on their clinical use. For Osteoporotic women, having balance training interventions leads to the to the outcome of significantly reducing falls and enhancing stability (Mikó et al., 2017). On the same note, Multicomponent programs that combine resistance and balance training have resulted in increased muscle strength, physical performance and health-related quality of life for patients with vertebral fractures, along with reduced fear of falling. (Stanghelle et al., 2020). Newer developments in this area such as virtual reality exercise programs have provided additional improvements in Balance performance and increased patient engagement in rehabilitation (Yilmaz \& Kösehasanoğulları, 2024).

Multisensory Environment-Based Occupational Therapy for Alzheimer's Patients

This study aims to examine the effects of a multisensory environment-based occupational therapy intervention on sensory processing, cognitive functions, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Non-pharmacological approaches to Alzheimer's disease management have been shown to slow functional decline, reduce behavioral symptoms, and improve caregivers' well-being. Multisensory environments provide visual, auditory, tactile, proprioceptive, vestibular, olfactory, and gustatory stimuli to support sensory integration and enhance engagement, particularly among individuals with cognitive and communication difficulties. The study will be conducted using a randomized controlled design and will include individuals aged 65 years and older with moderate-stage Alzheimer's disease and their primary caregivers. The intervention will be implemented over eight weeks, with two sessions per week. Outcome measures will include the Adult Sensory Processing Scale, Mini-Mental State Examination, Loewenstein Occupational Therapy Cognitive Assessment-Geriatric, Neuropsychiatric Inventory, and Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.

"Prehabilitation as a Predictor of Functional Success Following Rotator Cuff Repair: A Pilot Randomized Controlled Trial"

Rotator cuff injuries are the third leasing cause of pain and disability, accounting for 16% of all musculoskeletal injuries. Following surgical intervention, patients typically undergo a 4 to 6 week immobilization period before starting physical therapy. This rehabilitation phase can last between 4 to 6 months. Despite this, there is currently a lack of clear guidelines regarding specific physical therapy protocols or the expected post surgical recovery for patients who have undergone rotator cuff repair.

Development and Evaluation of a Self-Management Model for Cancer Rehabilitation

Participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. They were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model. During the intervention period, trained oncology advanced practice nurses conducted weekly questionnaire surveys for enrolled patients. During the follow-up period, these surveys were conducted every four weeks. Peripheral venous blood samples were collected at baseline and at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.

Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients

Conventional in-hospital mobility programs are challenging to deliver to hospitalized infected patients (e.g., COVID-19) due to infection risk to staff, staffing shortages, and potential exposure of other patients. This study evaluates a tele-exergame mobility program, a self-administered, game-based exercise intervention guided by foot-worn sensors and step-by-step interactive guidance on a tablet. The platform promotes strength, balance, and flexibility while enhancing patient motivation and engagement through cognitively demanding gamified tasks, with remote supervision and no to minimum direct physical contact.

Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program

Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. Patients with chronic nonspecific neck pain (CNSP) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. However, it is also reported that chronic pain occurs as a result of neuroplasticity, that is, the brain learning pain through the central synthesis mechanism in the central nervous system. For this reason, although the importance of central nervous system-oriented therapies is increasing day by day, this system-oriented therapies are still ignored in clinics. Therefore, in this master's thesis study, it is aimed to investigate the effects of central nervous system-focused therapies (pain neuroscience education, breathing exercises and relaxation exercises with guided imagery) on pain, range of motion, functional status, pain-related fear, anxiety, depression and quality of life in addition to traditional physiotherapy applied to patients with CNSP.

Animal Assisted Therapy

This study looks at whether walking with a therapy dog helps adult and pediatric trauma patients move more during their hospital stay. Early movement after an injury or surgery can prevent problems such as blood clots, pressure sores, and muscle loss, but pain and anxiety often make it hard for patients to get out of bed. Each patient in this study takes part in two walking sessions-one with a certified therapy dog and one without a dog. The order is randomized, so some patients walk with the dog first and others walk without the dog first. Before and after each walk, patients fill out short surveys about their pain, anxiety, and motivation to move. The research team measures how far and how long each patient walks in both sessions. The goal of this project is to see if therapy dog visits can safely and effectively improve mobility, reduce pain and anxiety, and make walking more enjoyable for trauma patients. Findings from this study may help hospitals design better rehabilitation programs that use animal-assisted therapy to support physical and emotional recovery.

Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)

This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility. The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT. Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits. The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients. At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ). The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly. For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years. Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.

Early vs. Late Referral for Scapular Exercises in Shoulder Function After Neck Dissection

This study aims to investigate the effects of comparing early versus late referrals for scapular-focused exercise on shoulder function in head and neck cancer patients following neck dissection.

Skilled Nursing Facility Care at Home

We will perform a parallel-group multicenter patient-level randomized controlled evaluation of skilled nursing facility care at home. Patients typically referred to a skilled nursing facility following hospitalization will be eligible for enrollment. Instead of admission to a skilled nursing facility, participants will receive care from a technology-enabled team in their own homes or will be allocated to receive care in a traditional skilled nursing facility setting.

Development of a Rehabilitation Strengthening and Mobility Program for Ventilator Dependent Older Patients

As the general population ages and technology advances, many who suffer from catastrophic critical illness (i.e. septic shock, respiratory failure, Acute Respiratory Disease Syndrome) survive only to find themselves severely physically debilitated and compromised from a pulmonary standpoint, requiring assistance from a mechanical ventilator in order to breath. Oftentimes, these patients require a long course of physical rehabilitation and ventilator support. These patients frequently remain ventilator dependent for greater than 3 weeks, and are thus referred to as requiring prolonged mechanical ventilation (PMV). Older patients are at significantly higher risk for requiring PMV for reasons that are not entirely clear, but which may include physical deconditioning, impaired cardiopulmonary physiology, and cognitive or behavioral disturbances. The purpose of this study is two fold: 1. to characterize the functional phenotype of ventilator dependent, and recently ventilated patients with respect to general strength, endurance, balance, and pulmonary functioning and body composition. 2. To pilot test a rehabilitation protocol that targets improving this populations disabilities through exercises focused on improving strength, endurance, balance, and pulmonary functioning.

Is Adding Extracorporeal Shock Wave Therapy to Physiotherapy and Corticosteroid Injection Beneficial for Frozen Shoulder

Frozen shoulder, or adhesive capsulitis of the shoulder, is a common clinical problem characterized by pain, loss of both passive and active range of motion (ROM) of glenohumeral joint (GHJ), leads to functional limitation, and reduces quality of life. Primary frozen shoulder occurs without any obvious connection to any other condition, and secondary frozen shoulder is related to some medical problems, such as an injury, inflammatory, immunological, and endocrine conditions, or surgery of the shoulder. The prevalence of frozen shoulder is 2%-5% in general population, usually between 40 to 60 years old, and more in female. Diabetes patients have more chance of developing frozen shoulder than general population and the prevalence was 13.4%. Frozen shoulder is clinically divided into 3 overlapping phases. The painful freezing phase has a duration of 10 to 36 weeks and is characterized by pain and stiffness around the shoulder, which may worsen at night. The frozen phase is characterized by restricted ROM with a gradual relief of pain, which occurs at 4 to 12 months. The thawing phase with spontaneous improvement in the ROM takes 12 to 42 months. .Although frozen shoulder is a self-limited condition, the recovery may be slow and incomplete. Treatment of frozen shoulder consists of physiotherapy, oral medication (nonsteroidal anti-inflammatory drugs or corticosteroid), intra-articular corticosteroid injection, hydrodilatation, suprascapular nerve block, mobilization, manipulation under anesthesia, and operative intervention (arthroscopic release or open release). Because of the uncertainty of the efficacy and risk of surgical treatment, nonsurgical treatments are more likely chosen by patients. Among them, intra-articular steroid injection and physical therapy are commonly used nonsurgical treatments and have shown some benefits. .Because the clinical picture of frozen shoulder may be similar to, or combining with chronic subacromial bursitis, especially in the freezing stage, concomitant subacromial/subdeltoid (SASD) bursa injection may be needed for treatment of frozen shoulder. In addition, the 3 stages of frozen shoulder often overlap and the clinical symptoms of patients are complex, adjuvant therapy is often needed throughout the course of treatment. Even after physical therapy (PT) and corticosteroid injection, mild to moderate contracture, especially external rotation, abduction, and internal rotation may still be present. Over the past few years new evidence has emerged on the effectiveness of extracorporeal shock wave therapy (ESWT) in the treatment of many musculoskeletal disorders. Briefly, ESWT has been shown to promote neovasculization, amplify growth factor and protein synthesis, increase of pain inhibiting substance, alteration of pain receptor neurotransmission, and intensification of tissue regeneration. Furthermore, ESWT can produce a cavitation effect between tissues, cause intertissue release, promote the separation of adhesion, and release the adhesive tissue. Because of its analgesic, anti-fibrotic, and anti-inflammatory effect, application of ESWT as main treatment or an adjunct to other interventions has been tried. Knoblock et al found that focused ESWT can reduce pain in painful nodules in Dupuytren's disease; in a randomized controlled trial Chen et al showed focused ESWT was superior to oral corticosteroid for frozen shoulder, although oral corticosteroid is not commonly prescribed for patients with frozen shoulder. Vahdatpour compared ESWT with sham ESWT on treatment of frozen shoulder after 40mg triamcinolone intra-articular injection, and found that ESWT group seemed to have positive effects on treatment, and quicker return to daily life. Another two studies investigating application of radial shock wave to patients with frozen shoulder showed improvement of ROM, even for diabetic patients. A systemic review and meta-analysis also showed ESWT seems beneficial to patients with frozen shoulder and could be used as an adjunct therapy to routine treatments. However, the authors mentioned that the quality of the included randomized controlled trials were hampered by significant heterogeneity regarding long-term analgesia and joint ROM. Because the effect of ESWT against frozen shoulder has not been well established, we aim to investigate whether adding ESWT to corticosteroid injection and routine PT beneficial for patients with frozen shoulder? We hypothesize that ESWT would be a positive adjunctive therapy in the treatment of frozen shoulder.

Effect of Oral Nutritional Supplements to Older Patients Discharged With a Rehabilitation Plan

The purpose of the study is to investigate whether an extra intake of energy and protein in the form of nutritional drinks twice a day for 12 weeks can improve muscle strength, muscle mass, quality of life and the implementation of rehabilitation in elderly patients at nutritional risk who are discharged to municipal rehabilitation

Implementing Powered Mobility in Early Childhood Settings for Children With Cerebral Palsy

The goal of this clinical trial is to learn if a therapist training program can help providers in Part C Early Childhood Settings use powered mobility (PM) with young children who have cerebral palsy (Gross Motor Function Classification System Levels IV-V). The study will also look at whether this training is practical and useful for therapists, families, and children. The main questions it aims to answer are: 1. Can therapists successfully use the training to provide powered mobility interventions in home and early childhood settings? 2. Do families and children find the intervention acceptable and helpful? 3. What benefits do children show in mobility, participation, and engagement after using powered mobility? In this study, therapists and families will: 1. Take part in a training program about how to use powered mobility with young children 2. Use powered mobility devices (Permobil Explorer Mini) with children during everyday routines 3. Complete surveys, interviews, and observations about their experiences

Impact of Group Participation on Adults With Aphasia

The purpose of the study is to examine the impact of group participation on adults with aphasia. Participants will complete a standard pre-and post-assessment of language abilities (speech, comprehension, reading, and/or writing). Then participants will attend 90-minute weekly reading group sessions during an academic semester.

Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas

Pulmonary rehabilitation (PR) is a key non-pharmacological intervention for patients with chronic obstructive pulmonary disease (COPD), yet it remains underutilized, particularly among patients living in peripheral areas due to limited access, travel distance, and logistical barriers. Tele-pulmonary rehabilitation (TPR) has the potential to improve access to care, but its feasibility and effectiveness as a group-based intervention have not been well established. The aim of this study is to evaluate whether a group-based TPR program can improve treatment initiation and adherence compared to usual care, defined as referral to standard PR, among COPD patients living in peripheral areas. In addition, the study will assess the effect of the intervention on COPD exacerbations, symptom burden, quality of life, and patient satisfaction. This is a prospective randomized controlled trial that will enroll patients with COPD who are eligible for PR according to the Israeli health basket criteria and have not participated in PR in the past year. Participants will be randomly assigned to one of two groups: (1) referral to standard PR (control group), or (2) participation in a 12-week, twice-weekly, group-based TPR program delivered remotely via a dedicated application and video sessions (intervention group).

Tele-Pulmonary Rehabilitation For Patients With Chronic Lung Diseases

Pulmonary rehabilitation is a key treatment for lung diseases, but many patients struggle to attend sessions due to travel distances, physical limitations, or logistical barriers. The purpose of this study is to evaluate whether a tele-pulmonary rehabilitation (TPR) program can improve the rates of treatment initiation and adherence among patients with chronic lung diseases compared to traditional, center-based pulmonary rehabilitation. Additionally, the study will assess improvements in quality of life, physical symptoms, and safety in both groups. This study will enroll 90 patients from two medical centers in Israel (Tel Aviv and Barzilai). Participants will be randomly assigned to one of two groups: 1. The control group will receive usual care with a referral by a pulmonologist to standard pulmonary rehabilitation at a medical center. 2. The intervention group will participate in a supervised remote tele-rehabilitation program using a dedicated application and remote monitoring.

Stroke Rehabilitation Through Intensive Exercise

The goal of this clinical trial is to learn whether combining moderate to high intensity aerobic exercise with constraint-induced movement therapy (CI therapy) can improve walking ability in adults who have had a stroke. The study will also learn if telerehabilitation at home can support long-term recovery after intensive rehabilitation. The main questions this study aims to answer are: * Does moderate to high intensity aerobic exercise before CI therapy improve walking ability, balance and lower extremity function in people with long-lasting gait difficulties after stroke? * Does CI therapy alone lead to similar or different improvements in walking ability, balance or lower extremity function? * Does telerehabilitation help participants maintain or further improve their function after the intensive rehabilitation period? Researchers will compare two groups. One group will receive 4 weeks of CI therapy, 5 days per week, plus 20 minutes of moderate-to-high-intensity aerobic exercise before the rehabilitation session on 3 of these days, and the other group will receive 4 weeks of CI therapy, 5 days per week, without preparatory aerobic exercise. After the completion of CI therapy, all participants will be offered an individualized 8-week telerehabilitation program to follow at home. They will use a mobile application to report physical activity and follow instructions for telerehabilitation. All participants will complete two assessment visits (about 3 hours each), 1-2 weeks before and 1-2 weeks after CI therapy. They will also complete questionnaires electronically after the telerehabilitation program. Daily activity will be measured twice during the study: once during a week after the intensive rehabilitation and once during a week after the telerehabilitation program. A small movement sensor worn on the thigh will be used. The sensor is attached with a soft strap or an adhesive patch and is comfortable to wear all day. The sensor shows how much a person walks, stands, or sits in everyday life. It is light, does not disturb normal activities, and only collects movement information for the study. An instruction sheet will be included to make it easy to use.

Virtual Reality Mirror Therapy With Focused Object-Directed Attention System

In this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke. The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in stroke patients.

Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis

Peripheral facial palsy affects 15 to 40 people per 100,000 inhabitants and induces important functional and social repercussions. Synkinesis is a frequent after-effect of facial palsy recovery, consisting of involuntary facial spasms that disturb the gestural harmony and can go as far as a painful hypertonic spasm. More than 55% of patients recovering from facial palsy will develop transient or permanent synkinesis. These facial hypertonias have two main causes: imperfect axonal regeneration, which is all the more important as the damage is proximal, and hyperexcitability of the facial nerve nucleus due to a lack of central control. Management is therefore essential for the functional restoration of the face, especially since synkinesis do not evolve spontaneously. The main treatments are currently botulinum toxin injection, acting on the motor plate, and functional rehabilitation, consisting on local muscle relaxation and central motor control work. In recent years, therapies based on biofeedback and acting on central motor control have shown interesting results, and technological advances in virtual reality have made it possible to deepen this treatment in patients suffering from stroke, limb trauma or Parkinson's disease. In this project, the investigators evaluate the contribution of virtual reality to the management of facial palsy, and hypothesize that self-rehabilitation using this technology will improve motor control of the skin muscles and reduce complications related to their hypertonia such as synkinesis.

Personalized Rehabilitation Program for Elderly Patients That Fall

The risk of falling affects more than one third of people over 65 years old and over 50% of persons over 80 years. These falls have important consequences for the autonomy of the elderly patient and also increase the risk of sequelae and death. The goal of this study is to evaluate a personalized rehabilitation program for elderly patients that fall for the first time and to measure the impact on the fear of falling of these patients. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors.

Effect of Extracorporeal Radial Shock Wave Phonophoresis on Subacromial Space in Patients With Impingement Syndrome.

The goal of the study is to determine the effect of radial shock wave Phonophoresis on patients with impingement syndromes. to answer the following questions: does shock wave Phonophoresis have and effect on pain? does shock wave Phonophoresis have and effect on shoulder function? does shock wave Phonophoresis have and effect on subacromial space? patients will be randomized to two groups: Group (A): patients will receive shock wave Phonophoresis plus conventional physical therapy. Group (B): Patients will receive shock wave plus conventional Physical therapy.