Clinical Research Directory

Effects of Virtual Reality Multisensory Cooperative Task-Oriented Mirror Therapy

In the proposed study, the investigators assumed that Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Therapy (VRMCTOMT) will provide a better treatment effects than traditional virtual reality mirror therapy (VRMT) for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either VRMCTOMT, or VRMT on the upper extremity function and brain activity of the stroke patients.

Effect of Extracorporeal Radial Shock Wave Ibuprofen 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.

Bracing After Ankle Fracture

Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.

Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia

The aim of the study is to evaluate whether the effect of biofeedback treatment is more effective than a control treatment in the recovery of dysphagia. This study will be a multicentric randomized, single-blind controlled study. The investigators intend to recruit 100 patients who have suffered a stroke and have dysphagia. Fifty patients will undergo training with bio-feedback (experimental group) and the other fifty patients will undergo standard training, using only verbal feedback rather than visual feedback (control group). Our hypothesis, based on the results obtained in some previous studies, is that in the control group the efficacy of the treatment will be lower in the absence of immediate visual feedback of strength, timing, coordination and efficacy of the swallowing act.

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.

Co-designing a Stroke Rehabilitation Trial Toolkit

Clinical trials are a type of research that tests if a treatment works well and is safe, so future care can be improved. In stroke rehabilitation, clinical trials are essential for improving the lives of stroke survivors. Clinical trials follow detailed plans called protocols, that explain what activities should be done, by whom and when. This makes sure everyone in the trial does things the same way, so results are fair and consistent. Sometimes, stroke survivors or staff may not follow the trial protocol exactly. For example, someone might miss a session or do different exercises. This is called low adherence. There are many reasons this can happen; the exercises or schedule may be too hard, the trial or activities do not match what stroke survivors or staff need, prefer, or find helpful in real life. If protocols are not followed properly, the trial results of clinical trials may not be reliable. This can slow down the process of getting better treatments into hospitals and make it harder to improve rehabilitation for future stroke survivors. Previous research has looked at what helps and gets in the way of adhering to protocols during hospital-based stroke rehabilitation trials. The research has identified many factors, including the healthcare system, hospital environment, staff, patients and the rehabilitation activities or schedules. Most of this research focused on the views of staff involved, meaning important perspectives may be missing from others involved in stroke rehabilitation trials. The investigators' study aims to change that. The investigators want to hear from people whose voices are often overlooked: stroke survivors, their family and friends, stroke rehabilitation staff and healthcare leaders working in the NHS, stroke rehabilitation researchers, staff working in Integrated Care Boards (who help plan and coordinate NHS services in local areas) and representatives from organisations who fund stroke rehabilitation research. The investigators will use a process called co-design. This means working together to develop a toolkit to help improve adherence in future stroke rehabilitation trials. Toolkits are already used in healthcare to help people do things better. For example, changing how care is given, supporting patients, or helping health teams work more smoothly. But currently, there is no toolkit designed specifically to help improve adherence to stroke rehabilitation trial protocols. This research aims to design a toolkit together. The toolkit will be shaped by a wide range of voices, especially those from underrepresented groups, and made in a way that's easy to understand and use. By addressing potential barriers early on, the investigators hope the toolkit will make it easier for future stroke rehabilitation trials to succeed, leading to better recovery and quality of live for stroke survivors.

Spinal Cord Stimulation and Respiration After Injury

Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.

Rehabilitation of Upper Limbs After Stroke

The aim of the research will be to evaluate the effects of upper limb rehabilitation using modern Pablo Tyromotion technologies in people after stroke in the late period.

Skilled Nursing Facility at Home Trial

Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.

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.

Artificial Intelligence-Driven Virtual Reality Rehabilitation for Upper Limb Recovery in Acute and Subacute Stroke Patients

Background: Upper limb motor deficits are common after stroke, and early rehabilitation is crucial for functional recovery. Virtual reality (VR) combined with artificial intelligence (AI) has shown potential to enhance motor learning, but evidence from randomized controlled trials in acute and subacute hospitalized patients is limited. Objective: To evaluate whether AI-driven VR rehabilitation in addition to standard care improves upper limb motor recovery compared with standard rehabilitation alone in acute and subacute stroke patients. Design: Prospective, assessor-blinded, randomized controlled trial with stratified 1:1 allocation by baseline Fulg Meyer Assessment Score.S Participants: Adults (≥18 years) with confirmed acute or subacute stroke, admitted to the hospital, with upper limb motor déficits. Intervention: Experimental group will receive standard rehabilitation plus AI-driven VR therapy during hospitalization. Control group will receive standard rehabilitation alone. Primary Outcome: Change in FM-UE score from baseline to hospital discharge. Secondary Outcomes: VR-derived digital biomarkers, therapy adherence, NIHSS, FM-UE, and Modified Ashworth Scale at each session, and the following baseline and treatment variables: etiology, Modified Rankin Scale (mRS), handedness, stroke lateralization, aphasia, acute reperfusion, reperfusion treatment, days from stroke to start of rehabilitation, adverse events, patient satisfaction, and date of discharge. FM-UE at 1 month post-intervention. Randomization and Blinding: Patients will be randomized in a 1:1 ratio to either group, stratified by baseline FM-UE (≤30 vs \>30) to ensure balance between groups for stroke severity. Within each stratum, block randomization will be used. Outcome assessors will be blinded. Sample Size: 50 patients (25 per group). Ethics and Registration: Approved by hospital ethics committee. Significance: This trial will provide evidence on the effectiveness of AI-driven VR therapy for early upper limb rehabilitation in hospitalized stroke patients.

The Effect of Percussion Massage Therapy in Stroke Patients

Stroke is an acute neurological condition resulting from cerebral ischemia or hemorrhage, frequently leading to impaired motor function, increased muscle tone, and deficits in balance and gait. Spasticity is a common long-term complication in individuals with chronic stroke and significantly affects functional mobility and quality of life. Percussion Massage Therapy (PMT) is an emerging intervention that combines principles of mechanical vibration and traditional soft tissue techniques. Although previous research has examined its effects in musculoskeletal and athletic populations, evidence regarding its use in individuals with chronic stroke remains limited. The aim of this study is to investigate the effects of percussion massage therapy on muscle tone in individuals with chronic stroke and to determine whether changes in muscle tone are associated with improvements in gait and balance performance.

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 status, behavioral and psychological symptoms, and caregiver burden in individuals diagnosed with Alzheimer's disease. Non-pharmacological approaches in Alzheimer's 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 in 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 four weeks with two sessions per week. Outcome measures will include the Adult/Adolescent Sensory Profile,Loewenstein Occupational Therapy Cognitive Assessment-Geriatric version, Neuropsychiatric Inventory, and Zarit Caregiver Burden Inventory. The study is expected to contribute to the evidence base supporting sensory-based occupational therapy interventions in dementia care.

Virtual Activities of Living for Occupational Rehabilitation

Duke University will serve as the clinical research site for the Phase II RCT of the VALOR system, which enables telehealth delivery of evidence-based upper extremity (UE) stroke therapy in a patient's home using immersive VR headset technology for guided practice of activities of daily living (ADLs) and instrumental ADLs (IADLs). The study compares VALOR Home Exercise Program (HEP) to Usual Care Treatment (UCT) in adults with stroke-related UE impairment.

Exergame vs Balance Training in Hemiplegia

Hemiplegia rehabilitation is a long and demanding process, but with the right approach and patience, it is possible to regain lost functions and improve quality of life. Balance plays a critical role in helping stroke survivors regain independence. This randomized controlled study aims to compare the effects of balance exercises and video-based exergame training, in addition to conventional physiotherapy, on lower extremity functionality, balance, gait, daily living activities, quality of life, and fear of falling in patients with hemiplegia following stroke. A minimum of 30 eligible participants will be randomly assigned to two groups: Group 1 (Balance Exercise Group): Conventional physiotherapy plus balance exercises. Group 2 (Exergame Group): Conventional physiotherapy plus video-based exergame sessions using the Nintendo Switch Ring Fit Adventure. Both interventions will be conducted twice a week for four weeks under the supervision of a physiotherapist. Assessments will be performed before and after the intervention using standardized scales.

Rehabilitation With Biofeedback for People After Stroke

The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.

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.

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.

Music-Augmented Rhythmic Gait Training in Multiple Sclerosis

This randomized controlled trial aims to compare the effects of technology-based rhythmic gait training performed with and without music on walking performance and clinical outcomes in individuals with multiple sclerosis (MS). Thirty-two participants with mild to moderate disability will be randomly assigned to either a music-assisted rhythmic gait training group or a non-music control group, with both interventions delivered via telerehabilitation. Outcomes related to gait performance, balance, fatigue, and cognitive function will be assessed before and after a four-week intervention period.

Early Postoperative Pain Following a Limb Amputation

The primary aim of this study is to characterize the trajectory of pain and functional recovery in the first post-operative period following a limb amputation. Secondarily, this study aims to conduct an exploratory analysis to evaluate potential associations between clinical, demographical and therapeutical variables and primary outcomes including pain intensity, pain control and functional recovery.

Sex-specific Determinants of Early-phase Recovery From Skeletal Muscle Disuse

This project is a 2-phase, randomized clinical trial that includes 7 days of unilateral leg disuse (Phase 1), immediately followed by 1 week of bilateral leg rehabilitation (Phase 2). The investigators will recruit cohorts of healthy middle-aged men and women to address their aims: * Demonstrate the sex-specific effects of skeletal muscle disuse (Phase 1) * Identify key molecular determinates of susceptibility of skeletal muscle atrophy (Phase 1) * Map the early, sex-specific molecular time-course of rehabilitation (Phase 2) * Determine if disused and healthy muscle respond similarly to exercise (Phase 2) Healthy, middle-age men and post-menopausal women (50-65 years) will be recruited from the greater Houston/Galveston area. This under-represented research demographic demonstrate few negative metabolic or phenotypic signs of advanced age, but are at increased risk of being hospitalized and experiencing accelerated loss of lean mass and muscle function that parallels a much older population. The goal of this study is to characterize phenotypic and molecular skeletal muscle changes in middle-aged men and women during critical periods of disuse and rehabilitation and ultimately direct the development of targeted and effective prevention and treatment strategies.

Immediate Weightbearing vs Delayed Weightbearing

The purpose of this study is to perform a feasibility trial of immediate versus delayed weight bearing following fixation of fractures of the lower extremity, pelvis, and acetabulum. The investigator will enroll patients from Shock Trauma over a period of 12 months, and randomize them to immediate weight bearing as tolerated (WBAT) versus delayed WBAT (non-weightbearing for 6-12 weeks). Four specific feasibility criteria will be assessed: enrollment (target 50%), follow-up (target 90% at 3 months), correct documentation of weight bearing (target 90%), correct documentation of primary outcomes, which include reoperation and hardware failure (target 90%). Target enrollment is patients with fractures where the current standard of care is delayed WBAT; for lower extremity this will include fractures of the distal femur, proximal tibia, and distal tibia, including select fractures with intra-articular extension. If feasibility criteria are met over the course of this study, the investigator hopes to move forward with a multicenter randomized controlled trial on this topic.

Effect of Technology Enriched Rehabilitation After Stroke

The Biomedical Engineering Dept, University of Strathclyde, co-creates rehabilitation technology. In 2023-2024 a clinical study (NCT06787768) was conducted to understand the feasibility of a multi-technology approach to rehabilitation early after stroke. This was successful and leads to the next phase which is to gather preliminary evidence of the effectiveness of this approach by monitoring change in the mobility of patients who receive this intervention compared with usual care which will be gathered through a data linkage project (tracking the outcomes from matched patients from other parts of Scotland who receive usual care).

Inpatient Post-Acute Rehabilitation For Patients in the Midwest: a Prospective Cohort Study of Clinical Characteristics and Process Outcomes

Rehabilitation improves health outcomes, reduces disability and improves quality of life. There is a significant and emerging body of international evidence to support the benefit and cost effectiveness of specialist rehabilitation services within a modern health service. The demand for rehabilitation services is growing with changes in populations and with the advances in health care and new interventions and technology. Our overall aim is to explore the outcomes and clinical characteristics of adults who are admitted to a rehabilitation hospital in the Midwest region of Ireland during admission, at the time of their discharge and at 6 months.