Clinical Research Directory

Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults

People with cerebral palsy (CP), muscular dystrophy (MD), spina bifida, or spinal cord injury often have muscle weakness, and problems moving their arms and legs. The NIH designed a new brace device, called an exoskeleton, that is worn on the legs and helps people walk. This study is investigating new ways the exoskeleton can be used in multiple settings while performing different walking or movement tasks, which we call ubiquitous use. For example, we will ask you to walk on a treadmill at different speeds, walk up and down a ramp, or walk through an obstacle course. Optionally, the exoskeletons may also use functional electrical stimulation (FES), a system that sends electrical pulses to the muscle to help it move the limb.

Imaging Skeletal Muscle Mitochondrial OXPHOS Activity In Acute Lymphoblastic Leukemia Survivors

The participants are being asked to take part in this trial, because the participant is a survivor of childhood cancer or agreed to be part of a volunteer group to understand the relation between cancer and cancer treatment and muscle weakness in survivors of Acute Lymphoblastic Leukemia (ALL). ALL is cancer of the blood and bone marrow. Primary Objective • To compare muscle mtOXPHOS activity and satellite cell content among ALL survivors and controls. Secondary Objective * To evaluate the association between muscle mtOXPHOS, muscle satellite cell content and physical performance in ALL survivors. * To evaluate the association of muscle morphology and epigenetics with muscle mtOXPHOS in ALL survivors.

Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness

In this mono-center pilot trial, surgical patients who are at high risk to be admitted to intensive care will be screened and asked for participation. We are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing. Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.

Mitigating Neural Hypoexcitability and Weakness During Disuse in Women

Clinical trial The goal of this clinical trial is to learn how muscle weakness and atrophy develop during short periods of arm immobilization and whether a type of exercise called cross-education can help reduce these effects in women at midlife. The main questions it aims to answer are: What changes happen in the nervous system that lead to weakness when a wrist is immobilized? Can training the opposite arm help maintain muscle strength, muscle size, and nervous system function in the immobilized arm? Researchers will compare women who have their wrist immobilized with or without opposite-arm resistance training. Participants will: Wear a wrist cast on one arm for 7 days Complete strength training with the opposite arm or no training, depending on their group Attend study visits for strength and nervous system testing Have non-invasive tests (like magnetic brain stimulation, muscle recordings, and muscle imaging) to measure how the nervous system and muscle responds

Reduction of Muscle Catabolism Through Brain Activation in Burn Patients

Patients with extensive burn injuries frequently develop severe skeletal muscle wasting and weakness as part of critical illness-related myopathy and neuropathy. This condition delays ventilator weaning, prolongs intensive care unit (ICU) and hospital stay, and contributes to long-term functional impairment and reduced quality of life. In burn patients, muscle loss is particularly pronounced during the early post-injury phase and is associated with mitochondrial dysfunction and altered neuromuscular signaling. Effective strategies to prevent muscle catabolism in critically ill burn patients remain limited. Although early active rehabilitation is beneficial, many patients are unable to participate due to deep sedation, mechanical ventilation, or clinical instability. Therefore, innovative rehabilitation approaches applicable during the acute phase of critical illness are needed. The REMBRANT (REduction of Muscle catabolism through BRAin activation in burn patieNTs) study is a single-center, randomized, controlled, open-label clinical trial evaluating whether a multimodal brain-activating rehabilitation strategy can attenuate skeletal muscle loss in adult patients with severe burns. Thirty patients with burns involving more than 30% of total body surface area who require invasive mechanical ventilation and prolonged sedation will be randomized in a 1:1 ratio to standard care or an intervention group. Both groups will receive standardized burn treatment and conventional rehabilitation. The intervention group will additionally receive the Burn-Bundle Extended Rehabilitation Program, combining inhalational isoflurane sedation with functional proprioceptive stimulation, repetitive transcranial magnetic stimulation, and virtual reality-assisted rehabilitation when clinically feasible. The primary outcome is change in skeletal muscle mass and strength. Secondary outcomes include ICU length of stay, ventilator-free days, mitochondrial function, and health-related quality of life.

A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases

A Phase 1 dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of anito-cel in subjects with generalized myasthenia gravis (GMG). Anitocabtagene autoleucel (anito-cel) is a BCMA-directed CAR-T cell therapy.

Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy

Lumbar disc herniations may result in lower limb weakness. In such cases, there is a strong indication for surgical intervention through microdiscectomy. This clinical study aims to investigate preoperative factors that may influence the postoperative outcomes of patients undergoing this procedure.

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.

THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.

Reliability of Muscle Strength and Activation Assessment Tools and Effects of an Online Therapeutic Exercise Program in Patients With Chronic Kidney Disease

This research aims to evaluate the reliability and reproducibility of muscle strength and activation measurement tools, including isokinetic dynamometry and surface electromyography, in patients with chronic kidney disease (CKD). Additionally, the study will assess the feasibility and potential benefits of an online therapeutic exercise program supervised by physiotherapists.

Inspiratory Muscle Training Immediately After Lung Transplantation

Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life. Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease. The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.

Abdominal and Core Exercises on Respiratory Functions in Obese and Overweight Women (COREBREATH)

This study aims to examine the effects of an 8-week Pilates-based exercise program on breathing functions in overweight and obese women (BMI ≥ 25). The program includes exercises for abdominal endurance and core stabilization, performed three times a week. Participants will be divided into two groups: an exercise group and a control group. Before and after the program, measurements will include lung function (spirometry), breathing rate, breath-holding time, abdominal mobility, core endurance (curl-up test), and quality of life (SF-36 questionnaire). The goal is to find out whether this type of exercise can improve breathing and overall health in women with excess weight.

Muscle Recovery After Critical Illness

The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness: 1. to examine the recovery of muscle and physical function in ICU survivors through longitudinal assessments 2. to investigate the underlying cellular markers and mechanisms of muscle recovery in ICU survivors 3. to determine which cellular markers contribute to physical disability in ICU survivors up to 1 year after hospital admission

FIT Exercise in 30d of ULLS-induced Muscle Disuse

This study aims to determine how flywheel-based inertial training (FIT) implemented according to principles of velocity-based training (VBT) and High-Intensity Interval Training (HIIT) affects disuse-induced physical de-conditioning including loss of voluntary muscle strength, aerobic capacity, and balance regulation.

Development of the Italian Version of the ICU Mobility Scale (IMS). Cross-cultural Adaptation, Italian Translation, and Validation Study.

Early mobilisation of the patient admitted to intensive care units (ICUs) is essential to prevent Intensive Care Unit Acquired Weakness (ICUAW). It is essential to be able to measure functional mobility in order to evaluate the effectiveness of early mobilisation, both in clinical and research settings. The ICU Mobility Scale (IMS) is a validated scale that can be used to describe the functional level of the critically ill patient according to a categorical scale of 11 items. Each category describes the patient's capabilities from a mobility point of view. The main objective of the study is the validation of the Italian version of the IMS (IMS-it) on a cohort of patients admitted to intensive care. Secondary objective is to assess the concordance between the perception level that the healthcare worker has with regard to the patient's mobility, before the patient is mobilised, expressed with the IMSSecondary study objectives.

Examining the Effects of Vivo on Physical Function and Glycemic Level in Sedentary Older With Prediabetes.

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

Multivariate Biomarker Study for Sarcopenia in Heart Failure

In the United Kingdom, heart failure (HF) affects about 900,000 people with 60,000 new cases annually. Up to 60% of people living with HF also experience sarcopenia, known as loss of muscle mass and strength. Sarcopenia contributes significantly to low physical capacity and exercise intolerance and worsens the prognosis of the disease and quality of life. In comparison to primary sarcopenia (age-related sarcopenia), secondary sarcopenia occurs if other factors, including malignancy or organ failure, are evident in addition to aging. Secondary sarcopenia is highly common in patients with heart failure (Sarc-HF) (prevalence is 35%-69%), and has a significantly negative impact on exercise capacity, weight-adjusted peak maximal oxygen consumption, left ventricular function, and re-hospitalization rates and mortality. In this integrated study of NHS patients with HF, the investigators aim is to identify the underlying mechanisms of muscle weakness in HF utilizing including body composition, circulating metabolites (metabolic profile), and functional tests for (1) early detection of otherwise subclinical HF, (2) diagnostic assessment of clinically manifest HF-sarcopenia, (3) the risk stratification of subjects with a suspected or confirmed diagnosis, and (4) selection of an appropriate therapeutic intervention.

Effects of Early Rehabilitation Using Blood Flow Restriction and/or Surface Electromyography Biofeedback on Quadriceps Activation and Strength After Anterior Cruciate Ligament Reconstruction: A Multicenter Randomized Controlled Trial

Many patients experience quadriceps inhibition after anterior cruciate ligament (ACL) reconstruction, delaying strength recovery, hindering return to sport, and potentially increasing the risk of re-injury. Two rehabilitation strategies-low-load blood flow restriction (BFR) training and surface electromyography (sEMG) biofeedback-aim to enhance neuromuscular activation and strength while limiting joint load. However, comparative and combined evidence in pragmatic, multicenter settings remains limited. AMIRACL is a multicenter, prospective, randomized, controlled, parallel-group trial with four arms enrolling 200 adults (18-35 years) undergoing a first-time ACL reconstruction. Participants are randomized with center stratification; outcome assessors are blinded to allocation. The four groups are: (1) standard rehabilitation; (2) standard + early BFR; (3) standard + early sEMG biofeedback; and (4) standard + combined BFR and sEMG biofeedback. Interventions begin about 2 weeks postoperatively, are delivered over 6 weeks at three supervised sessions per week, and are integrated into contemporary ACL rehabilitation. BFR uses individualized, auto-regulated cuff pressure during low-load isometric and then dynamic exercises. sEMG biofeedback provides real-time visual and/or auditory feedback to optimize quadriceps recruitment during targeted tasks. The combined arm receives both modalities concurrently. The primary objective is to compare quadriceps activation (sEMG) and maximal isometric knee extensor strength between groups at 3 and 6 months. Secondary objectives include return-to-sport readiness and patient-reported function (e.g., ACL-RSI, IKDC), broader knee outcomes (e.g., KOOS, Lysholm), adherence and adverse events across arms, and ACL re-injury (ipsilateral graft rupture or contralateral ACL injury) within 2 years. Longer-term patient-reported quality of life is explored up to 5 years. Key eligibility criteria include age 18-35 years, first ACL reconstruction, and preinjury sport participation; major exclusions include revision ACL surgery, concomitant multi-ligament repair, neuromuscular disorders, and contraindications to BFR or sEMG. The planned sample size is 200 (50 per arm), powered to detect a clinically meaningful between-group difference in quadriceps activation. Analyses will follow the intention-to-treat principle using mixed-effects models for repeated measures. The study is conducted under Good Clinical Practice and applicable Swiss regulations; all participants provide written informed consent. Overall, AMIRACL will determine whether early BFR, sEMG biofeedback, or their combination meaningfully improves quadriceps activation, strength, and clinical recovery after ACL reconstruction compared with standard rehabilitation alone.

Effects of Biofeedback-Guided Training on Muscle Strength and Postural Alignment in Upper Cross Syndrome.

This randomized controlled trial investigates the effects of biofeedback-guided training versus conventional therapy on muscle strength and postural alignment in patients with Upper Cross Syndrome. The study includes adults aged 25-45 years meeting diagnostic criteria for UCS, such as weak deep cervical flexors, restricted cervical ROM, forward head posture, increased thoracic kyphosis, and chronic neck pain \>3 months. Participants are divided into two groups: Group A biofeedback training and Group B conventional therapy, receiving 12 sessions over 4 weeks ,3sessions/week. Assessments are conducted at baseline, post-1st session, and weekly intervals using standardized measures.The study aims to compare the efficacy of biofeedback-guided training in improving strength and posture in UCS patients.

Depo-Medrol on Psoas After LLIF

The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.

Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly.

With improved a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals. This study is a random control trial. Data collection includes elderly patient's total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized. The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.

Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation

Patients in intensive care often develop acquired muscle weakness (ICUAW or Intensive Care Unit Acquired Weakness) due to immobilization and muscle atrophy. Early mobilization can help reduce weakness and improve functional recovery, but practices vary. Muscle strength assessment, particularly using the MRC (Medical Research Council) score, is crucial, though it has precision limitations. Additional methods, such as manual dynamometry and functional scales, are needed to better track muscle recovery. The quadriceps, important for function, requires early evaluation, but there is a lack of specific data in intensive care to predict medium-term functional recovery.

Assessing The Effects of Exercise, Protein, and Electric Stimulation On Intensive Care Unit Patients Outcomes

Elderly patients who experience a prolonged ICU stay are at high risk for developing post intensive care unit syndrome (PICS), a serious medical condition manifested by loss of muscle mass, weakness, malnutrition and neurocognitive decline. PICS often leads to chronic disability, prolonged mechanical ventilation and the need for costly extended stays in long term care facilities (LTCs). The investigators' preliminary study shows attempts at rehabilitating patients who have already developed PICS are minimally effective, resulting in only modest improvements in functionality. This project will determine the effects of mobility-based physical rehabilitation (MPR) combined with neuromuscular electric stimulation (NMES) and high protein supplementation (HPRO) early in a patients ICU stay on preventing PICS related musculoskeletal and functional deficits, and improving clinical outcomes.

NASM OPT for Gluteal Enhancement in Non-Athletic Women: An RCT

This RCT evaluates a 12-week NASM OPT program targeting gluteal muscle strength, hip aesthetics (shape, lift, circumference), and low back pain in 120 non-athletic women. The intervention group performed structured resistance training, while the control group engaged in general exercise. Outcomes included gluteal strength (dynamometer), aesthetic satisfaction (Likert scale), and functional performance (squat test).