Clinical Research Directory

Real World Pediatric Oncology Rehabilitation in Italy ( ReWori )

This observational study aims to describe changes in the functional abilities of children, adolescents and young adults with cancer who are undergoing physiotherapy or neuropsychomotor rehabilitation. This is real-world study aiming to describe normal rehabilitation pathways in many different hospitals or rehabilitation centres in Italy. The primary research question is: 1\) What are the longitudinal changes in functional abilities among these patients receiving physiotherapy or neuropsychomotor rehabilitation? The secondary research questions are: 1. What types of rehabilitation practices are implemented across AIEOP centres? 2. What are the rehabilitation needs among patients undergoing physiotherapy or neuropsychomotor rehabilitation? 3. How does health-related quality of life differ across the various stages of the rehabilitation pathway? Participants undergoing usual rehabilitation treatment are evaluated on their functional abilities on a monthly basis. If they agree to participate in this study, the main characteristics of the rehabilitation treatment and the monthly evaluation are collected.

Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction

The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention. Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups. Outcome measures of interest include: * muscle atrophy; * ankle function; * fatigability/manual muscle testing; * pain scores; * cardiovascular effects (heart rate, blood pressure).

Neck and Low Back Pain in Physical Therapy Students at The University of the West Indies, Mona, Jamaica

The purpose of this study is to determine the prevalence of neck and low back pain among physical therapy students enrolled at The University of the West Indies, Mona. It also aims to assess students' knowledge, attitudes, and practices regarding spine health and to evaluate the effectiveness of an eight-week standardised spine-specific exercise programme in reducing musculoskeletal pain and improving functional status among those reporting symptoms. The study will be conducted in two phases, beginning with a descriptive cross-sectional assessment of prevalence, followed by a prospective randomised controlled trial in which students experiencing neck and/or low back pain will be allocated to either a spine-specific exercise intervention group or a non-spine-specific exercise control group for comparative analysis of outcomes.

Immersive Physical Therapy in the Neonatal Intensive Care Unit (NICU)

To learn if and how the physical and occupational therapy program in the Newborn Critical Care Center helps parents with their stress levels and ability to meet the needs of their preterm infants.

Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?

Conventionally, physical therapy (PT) clearance is sought before total joint arthroplasty (TJA) discharge. However, PT staffing limitations may preclude same-day discharge in patients having surgery late in the day. Failed same-day discharge in eligible TJA patients results in unnecessary hospital bed occupancy, which increases costs, limits operating room throughput for patients requiring inpatient admission, and introduces risks associated with longer length-of-stay. In collaboration with an institutional PT department, the investigators developed a protocol for discharging same-day TJA patients without postoperative PT clearance. Immediately preoperatively, PT administers gait training. Patients are then discharged home after ambulating with post-anesthesia care unit (PACU) nurses trained by PT on postoperative mobilization. This allows for the maximum number of patients discharged home, including the last patient of the day, PT staffing limitations notwithstanding. Single-institution pilot data demonstrates no increased risk of falls, emergency room (ER) visits, or readmissions with this process. The investigators propose a prospective, controlled, multicenter study to expand on pilot data. The study aim is to assess safety of day-of-surgery preoperative PT and postoperative ambulation with PACU nursing before TJA discharge. The primary endpoint is postoperative falls, while secondary endpoints include 90-day ER visits, 90-day hospital readmissions, patient-reported outcome measures, and patient satisfaction scores.

Art and Physical Therapy in Pediatric HCT

The purpose of this study is to compare the effect of a combination of art therapy (AT) and physical therapy (PT) to PT only in children undergoing hematopoietic cell transplant (HCT). Each child will receive daily AT and PT or only PT for 5 days per week for 2 weeks. These sessions will begin approximately on day 15 following the transplant. Prior to starting the sessions and following 2-weeks of sessions, self-care and mobility skills will be measured. During each session, the following variables will be measured: heart rate variability (i.e., time between heart beats) using a small monitor on the chest (about the size of a quarter), walking distance using an accelerometer (similar to wearing a watch), and self-reported happiness and excitability. Although results cannot be guaranteed, it is expected that each group will benefit and demonstrate improvements in emotional state, self-care, and mobility skills.

Study of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) Outcomes

This is a trial comparing self-directed rehabilitation using the Zimmer Biomet mymobility digital platform versus standard office-based physical therapy after reverse shoulder replacement. The investigators hypothesize that there will be no difference in the postoperative outcomes between the mymobility cohort and the standard office-based physical therapy cohort.

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.

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.

Virtual Reality and Dual-Task Training for Cortical Plasticity in Children With Brachial Plexus Injury

Brachial plexus birth injury (BPBI) is a condition that occurs when the nerves controlling the arm are injured during birth, leading to weakness, limited movement, and sensory problems. These motor difficulties may also affect cognitive processes related to movement. BPBI requires long-term follow-up and rehabilitation. This study will compare two treatment approaches in children with BPBI: * virtual reality (VR)-based exercises, and * motor-cognitive dual-task exercises. We will examine their effects on brain adaptation (cortical activation), muscle strength, joint motion, proprioception, and upper-limb function. Fourteen children aged 7-14 years will be randomly assigned to one of the two programs, each delivered for 12 weeks. Afterward, participants will continue a 9-month home program. Assessments will be conducted at baseline, after treatment, and at 12 months, including functional MRI (fMRI). This study will be the first to evaluate long-term brain changes and functional outcomes after these two rehabilitation approaches in children with BPBI.

Pain Perception and Exercise-Induced Hypoalgesia Across Circadian Rhythms

The goal of this randomized crossover clinical trial is to investigate whether exercise-induced hypoalgesia (EIH) is influenced by circadian rhythm in healthy adults aged 18-40 years. The main questions it aims to answer are: * Does the time of day (morning vs. evening) influence changes in pain perception following exercise? * Do chronotype, sex, or stimulation site (bony vs. muscular) alter the magnitude of this effect? Participants will: * Complete questionnaires * Undergo quantitative sensory testing * Attend both morning and evening sessions in randomized crossover order

The Effect of Mulligan and GMI on Distal Radius Proprioception

Distal radius fractures are common in the elderly population and clinical findings after treatment include limitation of joint motion, pain, and muscle weakness. Physical therapy modalities include exercises, physical agents, and manual therapy techniques. The Mulligan Concept-specific mobilization with movement (MWM) technique improves joint movement by reducing pain and is effective in musculoskeletal disorders. Graded motor imagery activates the motor system, increases neuroplasticity, and promotes functional recovery. It has been observed that proprioception is impaired after distal radius fracture, affecting muscle tone and postural reflexes. Our study will examine proprioception measurements with an electrogonometer (K Force Sens) and universal goniometer and the effectiveness of MWM and progressive motor imagery treatments. The study is designed as a one-blind randomized study and a total of 33 patients between the ages of 25-65 who were treated with volar plate screws after distal radius fracture will be included. Patients will be randomized as 11 people and one group will be treated with Mulligan Mobilisation in addition to conventional physiotherapy and the other group will be treated with Graded motor imagery techniques in addition to conventional physiotherapy. The control group will receive only conventional physiotherapy. Clinical Follow-up Form, Proprioception, Kinesiophobia, Hand Grip strength, Muscle strength, Pain, and functional evaluations will be performed 2 times in total, just before the patient starts physical therapy after surgery and at the end of the 6-week treatment. A goniometer and electrogoniometer will be used to measure proprioception. Visual Analogue Scale (VAS) and algometer will be used to determine the pain assessment. Jamar's hand grip strength meter and Digital Handheld Dynamometer will be used for muscle strength assessment. Tampa Kinesiophobia Scale will be used to measure the level of kinesiophobia. Patient Rated Wrist/Hand Evaluation (PRWHE) will be used to evaluate the functionality of the patients. Proprioception evaluation in the upper extremity is limited in the literature, and it will be an original study to examine the relationship between the two measurements after distal radius fracture surgery; in addition, it will be the first study to examine graded motor imagery and mulligan Mobilisation in terms of treatment efficacy.

Virtual Reality on Balance of Parkinson's Disease

This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. It aims to evaluate the effectiveness of a immersive virtual reality program in enhancing balance for patients with Parkinson.s disease (PD). PD is a neurodegenerative disease that has a major impact on patients' balance and gait, affecting their quality of life. Physical rehabilitation is crucial for maintaining and improving balance, and immersive virtual reality promises to be an alternative for improving outcomes in patients with PD.

Effectiveness of a Dual Program for Improving Sleep in Older Adults.

The present clinical trial aims to test whether a dual program of physical activity and cognitive training improves sleep and quality of life in people over 65 years of age.

Resistance Exercise and Sleep Quality by Chronotype

This study examines whether doing moderate resistance exercises in the morning can improve sleep quality and well-being in young adults. Participants with different daily activity patterns (morning or evening types) will take part in an 8-week online exercise program. The study will compare how exercise affects sleep, mood, and daily rhythm across these groups.

New Therapeutic Interventions and Imaging Techniques for Prolonged Shoulder Disorders

The RESSPECT study compares three types of physical therapy for adults aged 20-60 years with prolonged shoulder disorders, aiming to find better ways to help people recover and improve daily function. The study also examines modern imaging tests (X-ray, ultrasound, MRI) to see how well imaging findings match real symptoms, and tests new imaging technologies that may provide a more accurate diagnosis. The study improves future shoulder pain care by addressing both physical and psychological factors and advancing diagnostic imaging. Participants are randomly assigned to one of three groups: 1. Routine physical therapy (usual occupational care), 2. Tendon-Specific Exercise Program (TSEP): targeted exercises to build shoulder strength and 3. Psychologically Informed Physical Therapy (PIPT): combining physical rehabilitation with advice and emotional support. All participants get complete imaging of both shoulders and a clinical evaluation by a physiotherapist at the start of the study. Complete imaging is also done for all participants after twelve months. Surveys about pain, movement, mood, sleep, and quality of life are collected electronically at the start of the study, and at three, six, twelve, and 36 months. The main outcome is how well each person resumes everyday activities affected by shoulder pain (Patient-Specific Functional Scale, PSFS). Group 1 will receive routine occupationally led physiotherapy, and groups 2 and 3 will receive five physiotherapist-guided sessions during the first six month-period. Advanced imaging techniques will deployed in conjunction with standard imaging methods and compared to see whether new technologies help explain symptoms or guide care. To join, participants must have had prolonged shoulder disorders in one shoulder for at least four consecutive weeks, be employed or self-employed, and be willing to take part in rehabilitation activities. Certain medical conditions, prior surgery, and pregnancy are exclusion criteria. Inclusion and exclusion criteria are systematically reviewed in a structured phone interview at the start of the study. Baseline imaging is also viewed preliminarily for certain conditions which would require urgent medical care. If necessary, participants are contacted, informed and subsequently excluded from the study. The trial takes place at Oulu University Hospital, Finland. Approximately 300 people are recruited to the study via local ads. Informed consent is required for the study, and participants can withdraw at any time. All procedures meet ethical standards. This study will help determine: 1. Which therapy works best overall 2. Whether some people benefit more from certain therapies 3. If imaging findings help predict outcomes or aid treatment decisions 4. Whether new imaging technology improves diagnosis

Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum

Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively. Despite this prevalence, there is no currently accepted justification for performing labral repair in an asymptomatic patient despite the many postulated biomechanical benefits that an intact labrum imparts to the hip joint. Representing a smaller proportion of all tears, symptomatic tears of the acetabular labrum present a therapeutic challenge. Current treatment modalities range from conservative measures to open surgical intervention. Conservative measures have typically included: activity modification, the use of non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy (PT), core strengthening and improvement of sensory motor control. In the past two decades, technological advances in the form of surgical instrumentation and traction devices have facilitated less invasive arthroscopic techniques to diagnose and treat hip problems and as such is now the preferred treatment modality for many orthopedic surgeons treating patients with hip pathology. Determining which patients, using age and arthritic burden as predictors, can benefit from labral repair is paramount for several reasons. Showing arthroscopic repair is of little or no benefit to a specific cohort can reduce the number of unnecessary surgeries performed, increase the use of conservative therapy (if validated) and reduce the interval between diagnosis and total hip replacement.

Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long-term function after surgery. Neuromuscular electrical stimulation (NMES) reduces quadriceps weakness and improves patient function after knee replacement, but it is drastically underused in rehabilitation practice. This randomized trial will examine the effectiveness and feasibility of a comprehensive strategy for implementing neuromuscular electrical stimulation after knee replacement in two large healthcare organizations.

Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection

This study, titled: Telerehabilitation in Oncology Patients: Optimization of Prehabilitation and Rehabilitation Post-Colorectal Resection. Is a randomized clinical trial conducted at the Royo Villanova Hospital in Zaragoza, Spain. It aims to evaluate the effectiveness of a tele-rehabilitation program in enhancing functional capacity and quality of life for patients undergoing colorectal cancer surgery. Colorectal cancer (CRC) is a highly prevalent malignant tumor that significantly impacts global health and patients\' quality of life, particularly after surgery. Prehabilitation and postoperative rehabilitation are crucial for recovery, and telerehabilitation offers a promising alternative to improve outcomes in CRC patients.

The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms

Gynecological pelvic surgeries include procedures such as myomectomy, hysterectomy, and removal of ovarian cysts performed in the pelvic region of women. In the postoperative period following these surgeries, symptoms such as pain, decreased bowel motility, gastrointestinal problems, nausea, and vomiting are commonly observed. Effective management of these symptoms is important to accelerate the recovery process and improve the quality of life of patients. This study is planned to evaluate the effectiveness of physiotherapy during the hospitalization period after gynecological abdominal surgery and to examine the effects of different approaches on postoperative symptoms. In our study, participants who undergo gynecological abdominal surgery and meet the inclusion and exclusion criteria will be divided into four groups for intervention. In addition to routine care, interventions including physiotherapy, vagal stimulation, and a combination of physiotherapy and vagal stimulation will be applied from the postoperative period until discharge. The effects of these interventions on pain, bowel function, autonomic functions, pelvic floor function, and walking will be examined.

The Feasibility of LVHIIT on Inpatient Stroke Rehab

The objective of this study is to explore the safety and feasibility of conducting low-volume, high-intensity interval training (HIIT) on a total body recumbent stepper (TBRS) in persons with stroke in an inpatient rehabilitation setting.

Reflexo Therapy for Gestational Diabetes Mellitus

The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.

The Effect of Motor Image Training on Balance Performance in Geriatric Individuals

The goal of this study \[type of study: clinical trial\] is to was planned to investigate the effect of motor imagery training given to geriatric individuals with action observation on their balance performance and to compare these two methods. The main questions it aims to answer are: 1. Is virtual reality-based balance training given together with action observation and motor imagery for six weeks in geriatric individuals more effective in improving static balance than virtual reality-based balance training given alone? 2. Is virtual reality-based balance training given together with action observation and motor imagery for six weeks in geriatric individuals more effective in improving dynamic balance than virtual reality-based balance training given alone? 3. Is virtual reality-based balance training given together with motor imagery for six weeks in geriatric individuals more effective in increasing balance confidence than virtual reality-based balance training given alone? 46 geriatric individuals will be randomized into 2 groups. Along with action observation, motor imagery training and virtual reality-based balance training will be given to the study group. On the other hand, only virtual reality-based balance training will be given to the control group. All assessments will be repeated before and after the trainings. The trainings will be applied 2 days a week for 6 weeks. Each training session; 25 minutes for the control group and 45 minutes for the study group.

Comparative Efficacy of Intra-articular vs. MRI-guided Extra-articular Dextrose Injections in Knee Osteoarthritis Management

Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. The knee is one of the most easily injured joint in the body, and knee OA can become a chronic and disabling condition that pose a threat to not only the patient but also his or her caretakers and healthcare resources. The prevalence of knee OA is 5% - 15% in men over 60 years, and 10% - 25% in women aged more than 60. Knee OA can result from injuries, diseases, or wear and tear from overuse. It refers to structural changes that affect subchondral bone, articular cartilage, menisci, ligaments, synovium, and other joint structures. Currently, there are several conservative management of knee OA, including physiotherapy (therapeutic exercise, diathermy, electrotherapy), oral or topical medications, intra-articular and extra-articular injections, and radiofrequency. There are various substances used in injections for knee OA, among which are corticosteroid, platelet-rich plasma (PRP), AmnioFix, exosome, dextrose, and hyaluronic acid (HA). Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. The principle of hypertonic dextrose injection, "prolotherapy", is injection of small volumes of the irritant solution at or around the lesion in order to stimulate fibroblast and vascular proliferation, local tissue healing, reduction of joint instability, thus resulting in pain relief. Previous studies have demonstrated that prolotherapy resulted in clinically meaningful sustained improvement of function and pain in knee OA, and there were no severe adverse events related to hypertonic dextrose injection. A study in 2023 showed that among various dextrose concentrations, higher concentrations demonstrated greater improvement of knee OA, thus 20% dextrose is recommended. Regarding the site of dextrose injection in knee OA, previous studies demonstrated comparable effects of intra-articular and extra-articular injections. The periarticular injections include points around the knee where periarticular nerves exit the joint capsule, and acupuncture points at upper medial and lateral parts of knee joint. A study in 2024 revealed that prolotherapy combining intra-articular with peri-articular perineural injection resulted in better pain alleviation and improvement in knee joint function in knee OA. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). Radiography is used to assess osteophytes, joint space narrowing, and subchondral sclerosis, but it has limited ability to detect synovial inflammation, joint effusion, soft tissue abnormalities, and early cartilage damage. US can be used to evaluate synovial fluid and cartilage thickness, but not deep structures (e.g. subchondral bone change, meniscus tear, and ACL tear, etc.). On the other hand, MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures (e.g. ACL, meniscus, etc) in knee OA. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous laxity, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations, and signs of ligamentous laxity also provides target for ligaments injection. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings. Because the effectiveness of prolotherapy targeting lesion sites according to MRI findings has not been well established, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections. The investigators hypothesize that MRI could be a good choice for the guidance of prolotherapy targets.