Clinical Research Directory

Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment

This pilot clinical trial evaluates whether non-invasive brain stimulation improves the orientation and mobility (O\&M) skills of individuals with constricted visual fields in both eyes. The study is composed of three visits. The first visit is meant to confirm eligibility by performing a few clinical tests. Eligible participants will then complete two additional visits, one in which the participants receive active stimulation, and one in which the participants receive placebo (sham) stimulation. Stimulation will be administered in a randomized, double-blind order. To evaluate improvement, various measures of O\&M performance will be assessed on a standardized obstacle course featuring static natural and artificial obstacles at defined intervals after the intervention. We hypothesize that the application of hf-tRNS to V1 will improve the orientation and mobility skills of individuals with constricted visual fields immediately following stimulation as a results of enhanced periphery through modulation of the mechanisms responsible for crowding, thereby reducing crowding effects and improving contrast for individuals with rod-cone dystrophy and RP (genetic conditions), whereas for individuals with glaucoma (a neurogenerative condition), any improvement noted would be attributed to be enhanced processing of visual signal in the affected periphery. The results will inform the design of a future, larger-scale study.

Adolescent Elite Athletes: Trunk Mobility, Lower Extremity Flexibility, and Functional Balance Across Sports

This cross-sectional observational study compared trunk mobility, hamstring flexibility, and dynamic functional balance performance among elite male adolescent athletes aged 15-17 years from different sports branches, including wrestling, sprint athletics, canoe/kayak, and taekwondo. All assessments were conducted during a single baseline evaluation session using standardized, non-invasive clinical measurement tools. Trunk mobility was assessed using a digital inclinometer, hamstring flexibility was evaluated with the active Straight Leg Raise test using a goniometer, and dynamic functional balance was measured using the Y-Balance Test composite score on the dominant lower extremity. The findings of this study provide sport-specific reference data and contribute to the identification of biomechanical characteristics related to mobility, flexibility, and balance in elite adolescent athletes across different sports disciplines.

Randomized Clinical Trial to Improve Mobility After Hospitalization

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) to increase physical activity after hospital discharge to reduce incident mobility disability among older adults.

Testing Interventions for Mobility Through Exercise (TIME)

In this project, the team plans to test the impact of FAST, its brief home-based strength training program which includes performance goal setting, to a program for home (BAND TOGETHER) that is similar to one offered by Silver Sneakers, available online to millions of older adults, and includes strength, balance, and aerobic exercises. The team hypothesizes that the brief program (FAST) will improve leg function better than the standard program (BAND TOGETHER), by encouraging older adults to be more consistent with using it and to try harder when they do.

Improving Mobility After Revascularization in Peripheral Artery Disease

Lower extremity revascularization combined with supervised exercise significantly improves walking performance compared to revascularization alone in people who have PAD without limb threatening ischemia. However, supervised exercise is inaccessible or burdensome for most PAD patients. Investigators hypothesize that home-based exercise combined with lower extremity revascularization will significantly improve walking performance compared to revascularization alone in patients with PAD undergoing revascularization for disabling PAD. Investigators further hypothesize that inorganic nitrate, a major source of nitric oxide (NO) abundant in beetroot juice, will improve walking performance after lower extremity revascularization, compared to placebo. In preclinical models, NO inhibits inflammation, neointimal hyperplasia, thrombosis, and vascular smooth muscle cell migration at sites of revascularization. NO increases angiogenesis and perfusion, repairs skeletal muscle damaged by ischemia, and stimulates mitochondrial activity. In a randomized clinical trial with a 2 x 2 factorial design, the trial will test the following two primary hypotheses in 386 patients randomized within three months of a successful lower extremity revascularization for disabling PAD: First, that home-based exercise combined with lower extremity revascularization will improve six-minute walk distance more than revascularization alone at 6-month follow-up (Primary Aim #1). Second, that nitrate-rich beetroot juice combined with lower extremity revascularization will improve six-minute walk, compared to placebo combined with revascularization at 6-month follow-up (Primary Aim #2).

RIC (Remote Ischemic Conditioning) in Older Individuals

The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.

Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)

TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin. The digital twin will combine measurements from multiple body systems to create a participant-specific representation of physiologic state, resilience, and recovery. The study plans to enroll approximately 450 adults between 18 and 80 years of age. Participants will include generally healthy adults and adults with stable cardiometabolic, respiratory, or mobility-related conditions. Study measurements may include wearable-sensor data, heart rate and rhythm, blood pressure, oxygen saturation, autonomic responses, body composition, mobility, muscle function, sleep, activity, cognitive performance, point-of-care imaging, laboratory measurements, and optional biospecimens. Participants will complete a standardized resilience assessment consisting of rest, active standing, a six-minute walk, a cognitive dual task, and monitored recovery. Selected measurements will also be collected during home monitoring and follow-up visits for up to 12 months. The primary objective is to determine how accurately a locked digital-twin model predicts Whole-Body Recovery Burden, a research measure derived from the timing and magnitude of recovery across several physiologic systems. Model development and testing will be separated so that the final evaluation is performed in an independent validation cohort. This study does not assign participants to a medical treatment. Digital-twin outputs will not be used to diagnose disease, recommend treatment, or replace evaluation by a qualified health care professional.

Validation of the French Version of the New Mobility Score (NMS)

The incidence of hip fractures in France is 50,000 cases per year among women and 16,000 among men, with a 1-year mortality rate of 20-24%. After a fracture, 10-30% of patients become functionally dependent. The increasing aging of the population and the rise in dependency are likely to worsen the situation of older patients in hospital settings. Several tools are available to assess functional independence, including the New Mobility Score (NMS), which evaluates mobility through three domains: mobility indoors, mobility outdoors, and shopping activities. The NMS has shown good performance in predicting patient mortality and functional recovery, and its use is recommended in clinical practice. However, the French version of the NMS has not yet been validated. The French validation of the NMS is important to facilitate its implementation in clinical practice and research, particularly because of its simplicity and the need for rapid assessment tools for healthcare professionals. A French version of the NMS has been translated, and the MOB-SCORE study aims to assess its reliability and validity among healthcare professionals caring for patients with hip fractures.

Effects of Tele Rehabilitation vs Onsite Rehabilitation on Balance, Mobility, and Risk of Fall Among Geriatric Population With Knee Osteoarthritis

This randomized controlled trial aims to determine the effects of telerehabilitation versus onsite rehabilitation on balance, mobility, and risk of fall among geriatric patients with knee osteoarthritis (KOA). Knee osteoarthritis is a common musculoskeletal condition in older adults that is associated with pain, impaired balance, reduced mobility, and an increased risk of falls. Although onsite rehabilitation is effective, many elderly patients face barriers to accessing physiotherapy services because of transportation difficulties, physical limitations, and geographical distance. Telerehabilitation has emerged as an alternative approach that allows patients to receive supervised rehabilitation remotely using smartphone-based communication. In this study, eligible participants will be randomly assigned to either a telerehabilitation group or an onsite rehabilitation group. Both groups will receive the same balance and mobility exercise program for six weeks, with four sessions per week. Outcomes including balance, mobility, and risk of fall will be assessed at baseline, week 3, and week 6 to compare the effectiveness of the two rehabilitation approaches.

Evaluation of Choose to Move Replacement Ready (CTM-RR)

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the \>14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery. The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.

Bedside Bike Early Mobilization Program for Inpatients

Hospital immobility leads to serious complications including muscle loss, weakness, delirium, pressure ulcers, and blood clots. Despite being medically stable, hospitalized patients spend over 90% of their time in bed due to staffing shortages, fall risks, and limited physical therapy availability. Within one week of admission, patients can lose approximately 2% of thigh muscle mass per day, and nearly half develop clinically significant hospital-acquired weakness.The Bedside Bike is a portable, low-resistance exercise device that clamps securely to hospital beds, allowing patients to perform leg and arm cycling exercises safely without leaving their bed. This study will evaluate whether hospitalized patients at Indiana University Health facilities can feasibly and safely use the Bedside Bike to maintain mobility during their hospital stay.This quality improvement study will enroll 80 adult inpatients expected to stay at least 3 days. All participants will receive the Bedside Bike in addition to usual care (standard physical therapy and medical treatment). The study will measure how often patients use the device, whether it is safe (tracking any device-related problems), and whether it may help improve outcomes such as hospital length of stay, functional mobility scores, discharge to home, and rates of hospital-acquired weakness. Participants will have functional assessments at admission and discharge, use the Bedside Bike throughout their hospitalization (targeting at least 15 minutes daily), and be followed for 60 days after discharge to track readmissions, falls, living arrangements, and mortality.

Feasibility of a Co-designed Mobility Intervention After Hip Fracture Surgery

This clinical study examines whether a co-designed mobility intervention can be delivered in routine hospital care after hip fracture surgery. Hip fracture is a common and serious condition among older adults and is associated with loss of independence, complications, and increased mortality. During hospitalization, many patients remain inactive, even though early and frequent mobility is considered important for recovery. The HIP-ME-UP intervention was developed in collaboration with healthcare professionals, patients, caregivers, and hospital management. It aims to support early mobilization, independence in basic mobility activities such as getting in and out of bed and increased physical activity during hospitalization. The study will investigate whether the intervention is feasible to deliver in routine clinical practice, whether it is delivered as intended, and whether it is acceptable to patients and healthcare professionals. Participants admitted after a hip fracture surgery will receive the intervention during hospitalization. Researchers will collect information on recruitment, retention, fidelity, acceptability, and mobility-related outcomes. Approximately 25 participants will be included. The results will help determine whether a larger effectiveness study should be conducted.

Effects of a Powered Lower-Limb Exoskeleton on Walking Performance in Older Adults

The goal of this clinical trial is to learn whether a powered wearable lower-limb exoskeleton can improve walking performance in independently ambulatory older adults aged 65 to 75 years. The main questions it aims to answer are: * Does use of a powered lower-limb exoskeleton increase comfortable walking speed over 10 meters? * Does use of a powered lower-limb exoskeleton increase average walking speed during a 400-meter walk? Researchers will compare walking performance in older adults during walking with the powered exoskeleton and walking without the device to determine whether the exoskeleton improves mobility. Young-adult reference participants will also complete walking assessments to provide reference values for walking performance. Participants will: * Attend a screening and familiarization visit. * Complete walking assessments with and without the powered exoskeleton in randomized order (older adults only). * Perform a 10-meter walk test, a 400-meter walk test, and other physical performance assessments. * Complete questionnaires about balance confidence, fear of falling, and device usability. * Be monitored for safety events during testing.

Living Independence Through Functional Training

The purpose of the research is to evaluate the feasibility and benefits of a six-week hybrid task-oriented resistance exercise program for older adults who have been recently discharged from home health care.

Impact of Brief Daily Functional Resistance Training on Lower Extremity Physical Performance

In this study, we will randomly assign 360 older adults to 12 months of 5 minutes per day of functional resistance training or to a delayed treatment control condition, and measure the impact of the training on measures of lower extremity performance and walking ability.

Influence of the Culture Care Program on Patient Mobility After Thoracic or Abdominal Surgery: a Mixed-methods Study

A sedentary behavior in the postoperative phase has a negative impact on recovery from various types of surgery (e.g. abdominal, pulmonary, cardiac or esophageal). In fact, sedentary behavior in the days following surgery is associated with an increased risk of postoperative complications, longer hospital stays and, consequently, higher healthcare costs. Stimulating early mobilization and increasing the level of physical activity after surgery therefore remains a relevant current challenge. The Culture Care program will propose a new experience of the hospital towards an attractive and stimulating intrahospital environment, including art and culture. The hypothesis is that the innovative, positive hospital experience offered by the Culture Care program could contribute to increasing patients' mobility in the postoperative phase and thus reduce the sedentary behaviour compared with a control group included before the implementation of the program. The aim of this study is to explore the effect of the Culture Care program (Control group versus Culture Care group) on the mobility of patients hospitalized after thoracic or abdominal surgery, by determining the level of prediction in relation to the influencing covariates reported in the literature. The first quantitative part of this research project will compare the mobility of patients hospitalized after surgery, before (control group) and after the implementation of the Culture Care program (Culture Care group). Patients will be asked to wear an accelerometer for the first five post-operative days, and to complete three questionnaires (psychological well-being, physical recovery, perception of their mobility). Healthcare workers will be asked to complete a survey on their readiness to stimulate patients' mobility before and after the Culture Care program. The second part will be qualitative including individual semi-structured interviews with patients and healthcare workers during the Culture Care program, to gather their experiences.

Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps. The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients. The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.

Resistance-Based Multicomponent Training Plus Nutrition Supplementation for Intrinsic Capacity and Disability Risk in Chinese Rural Older Adults

This study is a five-arm, parallel-group, assessor-blinded randomized controlled trial designed to evaluate the effects of resistance-dominant multicomponent training combined with nutritional supplementation on intrinsic capacity and disability risk among rural Chinese older adults. A total of 220 participants aged 60 years or older with mobility decline, nutritional risk, sarcopenia risk, or pre-frailty/frailty will be randomly assigned to one of five groups: control, nutrition supplementation alone, resistance training alone, resistance training plus nutrition supplementation, or resistance-dominant multicomponent training plus nutrition supplementation. The intervention will last 12 weeks. Exercise interventions will be conducted three times per week, and nutritional supplementation will include leucine-enriched whey protein and vitamin D. The primary outcomes are the Short Physical Performance Battery score, FRAIL score, and activities of daily living/instrumental activities of daily living scores. Secondary outcomes include gait speed, Timed Up and Go test, sit-to-stand performance, handgrip strength, nutritional status, protein intake, serum 25-hydroxyvitamin D, calf circumference, and appendicular skeletal muscle mass index.

Observational Study on Changing the Quality of Life in Daily Life Activities After Clinical Approach Positioning the Wheelchair

Stemming from the common practice of attribution of the technical helps in the posture in Canada, the multidisciplinary approach of positioning develops in France for more than 10 years old. To date, no observatory study was led to estimate the impact of such consultation in daily activities, an essential objective conditioning the observance and the acceptance of assistive devices. This study wants to estimate the impact through modification of WHOM scale.

Stepping-Up: Partnering With the Community to Prevent Early Mobility Decline

Preclinical mobility limitations (PCML) manifest early in the process of declining mobility, and are not typically identified or acted upon by clinicians. These mobility limitations manifest as changes in how daily tasks such as walking are performed (slower speed, lower endurance). Persons in the PCML stage are at increased risk for the onset of disability and chronic disease. Persistent deterioration in mobility is a predictor of mortality and has been reported even in the absence of changes in activities of daily living over a two-year period. Further, older persons with mobility limitations, including reduced gait speed, are at risk for falls. These cumulative transitions of a person's life-long mobility form their mobility trajectory and preventing mobility decline at an early stage along this trajectory is the focus of this research initiative. This study will evaluate a novel intervention, STEPPING-UP, for improving walking ability in persons with PCML.

Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.

Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.

High-Intensity Exercise to Attenuate Limitations and Train Habits in Older Adults With HIV

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle, Washington. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit. The initial enrollment goal of 100 was increased to 120 in 2023 to facilitate a larger number of participants with key secondary outcomes.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of resO™ Bone and Joint Support Postbiotic on Physical Function, Pain Interference, and Mobility in Adults With Joint Discomfort

This randomized, double-blind, placebo-controlled study evaluates the effects of resO™ Bone and Joint Support Postbiotic on physical function, pain interference, mobility, and recovery in adults aged 18-75 years experiencing joint discomfort, stiffness, or reduced mobility. Participants will be randomized to receive either resO™ or placebo for 4 weeks. Outcomes will be assessed using validated patient-reported outcome measures, including PROMIS Physical Function, PROMIS Pain Interference, Duke Activity Status Index (DASI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), and pain numeric rating scales. The primary objective is to evaluate whether resO™ improves physical function and reduces pain interference compared with placebo.