Clinical Research Directory

Using Technology to Improve Function for Older Latinos With Disabilities in Underserved Areas

This project aims to test a culturally appropriate assistive technology (AT) intervention called VIVE-AT to help older Latinos with disabilities improve their function and quality of life. The researchers will first refine the VIVE-AT program based on feedback from a Community Advisory Board and focus groups with older Latinos with disabilities. Then, 76 older Latinos with disabilities will be recruited from a primary care clinic serving low-income communities in Puerto Rico. They will be randomly assigned to either receive the VIVE-AT intervention in the primary care clinic or be placed on a waitlist with regular phone calls. All participants will continue to receive standard care at the clinic.

CAPABLE Transplant

The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist, 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial, and 3) pilot test the feasibility and acceptability for CAPABLE Transplant in symptom and waitlist specific metrics amongst low-income active kidney transplant waitlist candidates.

CAPABLE Care + Connect

In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.

Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis

Lumbar spinal stenosis is defined as the narrowing of the spinal canal resulting from degenerative changes in the spinal joints, intervertebral discs, and the ligamentum flavum. Pressure fluctuations within the cerebral and spinal vascular systems lead to the formation of pulsations. The periodic occurrence of these pulsations in the dura mater is referred to as spinal dural pulsation.The vibratory movements of the dura mater have been interpreted as an indicator that the spinal cord is freely mobile within the subarachnoid space and not subjected to any external compression.This study aims to investigate whether the presence of dural pulsation is associated with clinical and radiological parameters in patients diagnosed with lumbar spinal stenosis

Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is a community-based research project led by the Marymount University Center for Optimal Aging (MCOA). The study is designed to help older adults in the Washington, D.C., Maryland, and Virginia (DMV) area maintain independence, mobility, wellbeing and brain health as they age. Adults aged 50 years and older will receive a comprehensive health assessment at the study site, Center for Optimal Aging- ALOHA Lab at Marymount University (MU) Ballston Campus in Arlington, Virginia. The assessment includes physical and cognitive testing, health and medical history, lifestyle surveys, and biometric measures such as blood pressure, grip strength, body composition by the InBody system, balance and gait speed. Participants will receive their results in a personalized "Health Passport," which summarizes findings and provides tailored recommendations to help manage modifiable health risk factors-such as those linked to Alzheimer's disease, cardiovascular disease, frailty syndrome, and depression. Participants will return annually for up to 5 years to repeat assessments and receive updated health and wellness recommendations. The study will track changes in health over time and explore the impact of the Health Passport on health behaviors, functional independence, and quality of life. ALOHA will also evaluate the cultural appropriateness of the Health Passport for diverse populations in Northern Virginia. The program incorporates an interprofessional research model, engaging researchers from multiple health professions to work alongside older adults, supporting both participants' wellness and optimal aging.

Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a Clinical Trial of a Bed Scale Device. Overweight Wheelchair Users Will Participate in a Weight Loss Program, Half Will Receive Bed Scales, and Participants Who Receive the Bed Scales Are Expected to Have Increased Weight Loss.

This project will complete the final design and development steps to commercialize the Fast In-Bed Tracking (FIT) Platform, which is an e-Health and wellness Internet of Things (IoT) monitoring system that can be integrated into a user's bed and provide person-centered, real-world outcomes to support health and wellness. The technical feasibility of FIT was proven over the past several years and has demonstrated the platform can support the treatment of several chronic conditions across different populations, including obesity, congestive heart failure, and pressure injuries. The project goals will be to (1) complete design refinements for FIT and (2) demonstrate the platform's efficacy to support weight loss goals of wheelchair users. Wheelchair users are twice as likely as the general population to be overweight or obese and excess weight not only exacerbates mobility and participation limitations but increases risk for secondary health problems. Evidence reveals that frequent weight monitoring is a key driver for weight management, which puts wheelchair users at a significant disadvantage, because they have no convenient way to measure their body weight. As a recent example, lack of participant's ability to self-weigh was a noted limitation to a weight loss program for wheelchair users, known as the Group Lifestyle Balance weight loss program Adapted for Individuals with Impaired Mobility (GLB-AIM). FIT solves this challenge by passively monitoring a user's weight when they get on and off their bed. The investigators lab and community-based feasibility trials demonstrated that FIT successfully tracks weight for individuals and couples sharing a bed and that users find FIT highly usable. This proposed project will allow the investigators to complete the design refinements participants recommended during our community-based feasibility trial and subsequently examine the efficacy of FIT in supporting the weight-loss goals of community-dwelling wheelchair users through a randomized controlled trial using the GLB-AIM.

Brief Cognitive Behavioral Therapy for People With Physical Disabilities

The purpose of this study is to examine the effectiveness of a psychotherapy (non-medication) treatment, Brief Cognitive Behavioral Therapy for Suicide Prevention, in reducing suicide ideation and attempts for people with physical disabilities.

Psychological Predictors of Pain and Disability in Patients With Chronic Low Back Pain After Manual Therapy

Low back pain has been reported to cause more disability than any other musculoskeletal health condition worldwide. About eight out of ten people will experience back pain at least once in their lifetime. The parameters that are usually evaluated in a low back pain condition are pain, functional disability and range of motion of the lumbar spine. There are studies that associate psychological conditions (self-efficacy, kinesiophobia, catastrophology, depression, anxiety) with pain and functional disability in patients with low back pain. However, the ability of psychological factors to predict progression after a program of physical therapy or therapeutic methods is not well studied. The main purpose of this study is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability after a manual therapy physiotherapy program in patients with chronic low back pain. A secondary purpose is to investigate the predictive potential of psychological factors in the improvement of pain and functional disability following a program of Pain Neuroscience Education (PNE) in patients with chronic low back pain. In addition, as a secondary purpose, it will be to investigate the effect of combining manual therapy therapy with PNE compared to manual therapy alone in patients with chronic low back pain. This study will involve 60 people aged 18-65 with chronic low back pain, who will be randomly divided by lots into 2 groups of 30 people. The 1st group (30 people) will be treated with manual therapy based on Maitland's principles (interview, evaluation, mobilization), without any use of physiotherapy machines, but with the use of personalized exercises. The 2nd group (30 people) will do the same as group 1 and additional volunteers will participate in before, in a training program in Pain Neuroscience Education (PNE). The total number of sessions that each volunteer will receive will be 6, the duration of each session will be about 45 minutes, the frequency of the sessions will be 2 times a week and the total duration of the intervention will be 3 weeks. The associations between psychological states and clinical characteristics (pain, disability and range of motion) will be carried out with the Pearson or Spearman correlation coefficient depending on whether the data are parametric or not. Multiple regression models will also be created with predictive factors for psychological states and a predictive variable for each of the clinical parameters. The significance level will be set to p=0.05.

Improving STEP in Stroke Patients

Stroke is the leading cause of acquired disability in adults. Stroke causes death in 10% of patients, disability and functional handicap in 60% of cases. Sequelea of hemiplegia include spasticity resulting in great difficulty and slowness in walking, gait instability, increasing the risk of falls. Deambulation may need help (cane, crutch, tripod cane, walker). Lower limb spasticity includes hypertonia of extensors (gluteus maximus, quadriceps, posterior gastrocnemius) resulting in equinovarus. A neurology deficit may be present on ipsilateral lower limb flexors. Hence the patient walks with rubbing of the tip of the foot (tip-toeing gait), resulting in a "mowing wheatslike" movement of the leg as described in the French literature. Walking is then slowed down, unstable, with increased risk of falls. In post stroke, during the period of rehabilitation and beyond, it is advisable to wear sports shoes although custom-made shoes improve walking and are reimbursed by the French social security system after prior agreement. Most of patients only wear conventional shoes.

Measuring Outcomes of Activity in Intensive Care

Millions of older adults are hospitalized for a critical illness each year and although they are more likely than ever to survive this illness, they commonly face significant morbidity in the form of disabilities in basic self-care activities and in mobility in the months and years afterwards. A better understanding of the underlying risk factors for disability following critical illness is greatly needed, including the effect that activity during hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between activity (measured more rigorously than in prior investigations) and disability, physical function, and cognitive function in survivors of critical illness 3 and 12 months after ICU discharge.

Phase 4 of Designed With You

The purpose of this study is to provide evaluate the feasibility of a structured 8-10-week, multi-component intervention that integrates individualized resource navigation, personalized self-care planning, emergency and end of life (EOL) preparedness, and peer support to improve the well-being, resource access and social connectedness of caregivers with disabilities. For this study we are interested in caregivers over the age of 18 who have some form (e.g. mobility or sensory) disability and are caring for a person with a disability and/or a chronic illness.

The Fit With Us Study

The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.

Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study

The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged \>60 years old who previously received chemotherapy drugs that can affect the heart. The purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.

Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study

The goal of this observational study is to determine if rehabilitation program intensity impacts functional recovery and specific needs in adult ischemic stroke patients who require inpatient rehabilitation. The main questions it aims to answer are: Do patients with stroke of Atrial-related subtypes (AFRS) have distinct rehabilitation needs and functional outcomes compared to non-AFRS patients? Does higher-intensity inpatient rehabilitation (3-5 sessions/day) result in better functional recovery at six months (measured by the Barthel Index) than moderate-intensity programs (1 session/day)? The study is non-invasive, does not interfere with usual care. The investigators' ultimate goal is to enhance the understanding of recovery after following different rehabilitation usual programs.

COgnitive and Physical Exercise to Improve Outcomes After Surgery (COPE-iOS) Study

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. To accomplish these goals, the Investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. At baseline and after discharge, the Investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional MRI). In this early stage trial, the Investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.

Red Blood Cell Transfusion in ECMO - A Feasibility Trial

Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intense treatment used to support critically ill patients who have suffered severe cardiac arrest, cardiac failure or respiratory failure (including severe cases of COVID-19). ECMO acts as a mechanical circulatory support temporarily replacing the function of the heart or lungs by oxygenating blood and removing carbon dioxide, allowing time for these organs to recover. Many critically ill patients, including those on ECMO, have an increased risk of bleeding and reduced production/increased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels \<120 g/l), a condition where the body lacks enough healthy RBCs to carry enough oxygen to the body's tissues. Therefore, patients on ECMO frequently require RBC transfusion, with clinicians having to decide if administering an RBC transfusion (with its associated risks) is higher than tolerating complications of anaemia. ROSETTA is a feasibility study that aims to determine the safety and feasibility of randomizing patients on ECMO to a restrictive RBC transfusion strategy (maintain Hb concentration above 70g/L) or to a more liberal transfusion strategy (maintain Hb concentration above 90g/L). Feasibility is defined as the ability to achieve a mean separation of at least 10g/L between the average lowest daily haemoglobin values in the two study groups.

Hand Rehabilitation Study for Stroke Patients

The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.

Pain Reduction Through Empowered Recovery (PRIME) Study

Chronic pain and depression or low mood are often experience by women who age with or into disabilities. Due to various factors women with disabilities often experience this cycle of pain and depression. Both of these conditions can be debilitating and lead to declines in health. Treating these conditions simultaneously, particularly , in older adults can be complicated due to side effects, risks of poor access to pain management and mental health care , and complications from other co occuring conditions. In order to address this cycle in older women with disabilities the investigators are testing the Women in Pain Reduction through Improved Mood and Empowerment (PRIME) study. The PRIME intervention includes four in person visits by a nurse to the women's homes where the participants set goals regarding pain and depression and the nurse helps the participants strategize ways to meet these goals. The second component of the study will be eight group sessions virtually with other participants in the study. The group sessions will be led by a clinical psychologist who will engage in Acceptance Commitment Therapy with the women.

Pain and Disability Outcomes in Post Amputation Patients

The objective of this study is to evaluate efficacy of varied medical and procedural therapies used to treat pain after surgical amputation of a limb. The primary outcome will be assessment of pain severity at rest and with movement as measured by pain scores on Numerical Rating Scale (NRS) 0 to 10, where 0 is not pain and 10 is the worst pain possible, taken on post-operative day 1, day 7, 30 days, 90 days, 6 months, and 1 year (+/- 3 days at each time point).

Evaluation of ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

The study is a prospective, multicenter, interventional, open clinical trial, in Single Case Experimental Design (SCED) in multiple introduction withdrawal, controlled, randomized.

Technology in Play for Children With Physical Disabilities: the Dice Model of Play

Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play. There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to kids that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study.

Nurse-led Rehabilitation to Improve Self-care Among Stroke Patients in Bangladesh

Stroke causes various levels of disability, which decreases physical function for a prolonged period. The purpose of this study is to test the feasibility and efficacy of a nurse-led rehabilitation program focused on improving the activity of daily living (ADL) among post-stroke patients in Bangladesh. A feasibility study, including descriptive and randomized controlled trial (RCT), will be conducted at the National Institute of Neuroscience \& Hospital (NINS\&H) in Dhaka, Bangladesh, from March 2025 to August 2025. Participants will be the post-stroke patients who got discharged from NINS\&H from 5th days to 2 weeks after the onset of stroke and the family caregivers of the patients and meet the inclusion criteria. The sample size will be calculated based on G-Power analysis with a medium effect size and will be 64. The intervention will be designed to provide the 3-month nurse-led rehabilitation program regarding self-care and the use of assistive devices. Assessment for rehabilitation will be performed by the multidisciplinary team with research nurses (RA nurses), physiotherapists (PT), and occupational therapists (OT). The control group will receive the usual care. The Functional Independence Measure (FIM) measures the primary outcome as improved self-care. The secondary outcomes are self-efficacy and participation in social activities for patients and the care burden of family caregivers. We also qualitatively describe changes and improvements of cognitive, emotional, and behavioral aspects among patients and their families. The endpoints will be compared at baseline and the 3rd month. Rehabilitation with proper assistive devices may improve self-dependence, ADL, and social participation. The caregiver's burden will decrease through the implementation of self-care education and assistive devices for daily life adjustment.

Immersive Virtual Reality and Physical Exercise on Cognitive and Functional Performance in Hospitalized Older Patients

This study will be conducted in a hospital in Spain to investigate how a special intervention using immersive virtual reality technology can benefit hospitalized older adults with difficulties in their daily functionality. The main objective of this study is to evaluate whether a cognitive stimulation intervention through immersive virtual reality, along with specific physical exercises, can improve the cognitive and physical function of hospitalized older patients. It is expected that this innovative intervention will have a positive impact on the quality of life of these patients. Participants eligible for the study must be over 75 years old, have severe functional dependency upon hospital admission, and be willing to participate. Those with severe dementia or other terminal illnesses will be excluded. Participants will be randomly assigned to one of four study groups: a control group without intervention and three intervention groups, including viewing Spanish landscapes through virtual reality, performing specific physical exercises, or a combination of both interventions. At the end of the study, various aspects such as cognitive and physical function, mood, quality of life, muscle strength, and acceptance of virtual reality technology by patients will be evaluated. This study aims to provide new insights into the care of hospitalized older adults and explore innovative ways to improve their well-being during their hospital stay

Effects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities

Physical inactivity is an increasing problem in the general population in society. However, in people with disabilities, inactivity is even more frequently reported. Physical activity on prescription (PAP) is a well-established method to enhance physical activity. The prescribed physical activity can be activities such as walking, cycling, swimming, or gardening, and should be performed over a longer period. In children with cerebral palsy, PAP has shown to be feasible to increase participation in physical activity and to reduce sedentary behaviour, and the habilitation services in the Region of Skåne have decided to offer PAP to all children and youth with disabilities. It is of great importance to study these interventions when applied on a broader group of patients than previously studied. The aim is to study the effects of an individualised and health-enhancing intervention in physically inactive people with autism, intellectual and physical disabilities. Also, the cost-effectiveness of PAP will be studied. 60 physically inactive children, aged 8- 17 years, and 20 adults, with autism, intellectual or physical disability will be included. The participants are recruited by their clinical physiotherapists, who also will be carrying out the PAP-intervention. The self-selected physical activity/activities may either be a physical activity organized by a club and/or an everyday activity such as walking a dog or riding a bicycle to school. Each participant fills in an activity logbook. Motivational interviewing will be used to support the participants. The Canadian Occupational Performance Measure can be used to identify what activities the participants are motivated to do, and to detect changes in the participants' perception of their performance of the activity. Quality of life will be monitored. Physical activity will be measured through the International Physical Activity Questionnaire (IPAQ) and a movement monitor (accelerometer). Study specific questionnaires will be filled in regarding costs and background information. Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne. Data will be collected at 3 months prior to the intervention, just before the intervention starts, when the intervention is finished, and at 6, 12 and 24 months after the intervention. The study has been approved by the Swedish Ethical Review Authority.