Clinical Research Directory

Myofascial Release and 20-m Speed in Wheelchair Rugby Athletes With Spinal Cord Injury

This study aims to investigate the effect of myofascial release on sprint performance in wheelchair rugby athletes with spinal cord injury. Participants will complete a 20-meter sprint test on two different days in a randomized crossover design: one day without myofascial release and one day immediately after the intervention. The myofascial release will be applied to the upper limb muscles involved in wheelchair propulsion using a handheld device for 90 seconds per muscle group. Sprint performance will be measured by the time required to complete the 20-meter distance. The study will compare performance between conditions to determine whether myofascial release improves speed.

Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.

Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury

The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure. The main questions are: How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year? The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.

High-intensity Walking Rehabilitation in Outpatient Subacute Spinal Cord Injury

People with incomplete spinal cord injury (SCI) often have some preserved movement and may regain walking ability, but recovery can be limited, and more effective rehabilitation approaches are needed.The goal of this clinical trial is to learn if high-intensity walking rehabilitation can improve walking recovery and overall neurological recovery in individuals with subacute SCI. The investigators are also exploring the process of incorporating this type of physical therapy approach in an outpatient rehabilitation setting. The main questions it aims to answer are: * Does high-intensity walking rehabilitation improve walking ability, compared to usual care for individuals with subacute spinal cord injury? * What are some of the barriers and facilitators to delivering high-intensity walking rehabilitation in an outpatient setting? The investigators will compare usual care rehabilitation to a high-intensity rehabilitation program to see if higher-intensity physical therapy leads to better walking outcomes and improved recovery. The study will also explore how feasible it is to deliver this type of program in a real-world outpatient rehabilitation setting and gather perspectives from both participants and clinicians. Participants will: * Attend regular outpatient physical therapy sessions focused on walking rehabilitation * Receive either usual care or a higher-intensity walking program delivered by their physical therapist * Have their activities, heart rate, step counts, and self-reported effort during therapy sessions monitored * Complete walking, balance, and neurophysiological assessments at the start and end of rehabilitation * Wear an activity monitor for one week at the beginning and end of the study to measure daily activity outside of therapy * Participants who receive the higher-intensity intervention may participate in an interview to share their experiences with rehabilitation

Radio-frequency (RF) Bladder Monitor

The goal of this pilot feasibility study is to evaluate a wearable microwave (MW)-based bladder monitoring system in adult volunteers and those with spinal cord injury (SCI) who use self-catheterization for bladder management. The study aims to learn whether the device can monitor bladder filling and estimate bladder volume non-invasively. The main questions the study aims to answer are: 1. Can the MW-based monitoring system distinguish between non-full and full bladder states? 2. How accurately do MW-based bladder volume estimates agree with ultrasound bladder scans and voided urine volumes? 3. Is the wearable monitoring system feasible, comfortable, and usable for individuals with SCI? Participants will: 1. Complete questionnaires about bladder symptoms and quality of life 2. Wear up to six non-invasive MW sensors on the lower pelvic region 3. Undergo two bladder filling and voiding cycles during the study visit 4. Have MW measurements collected approximately every five minutes during bladder filling 5. Undergo ultrasound bladder scans and bladder volume measurements for comparison 6. Complete a post-study usability and comfort survey

Improving Heart Health in Individuals With SCI Using Home-Based Virtual Gaming

What is the ultimate applicability of the research? Individuals with SCI face several challenges when trying to engage in exercise following injury. Barriers to engagement include cost, transportation, and lack of SCI accessible resources. At the same time, individuals with SCI are at risk of developing negative health consequences (e.g., cardiovascular disease) associated with physical inactivity. A critical need exists to improve relevant, accessible, and sustainable home-based exercise interventions for individuals with SCI to lower the risk of developing secondary comorbid diseases from physical inactivity and to promote wellness. This research will investigate a fun and novel in-home virtual reality system aimed toward improving physical fitness of individuals SCI with the ultimate goal of improving physical, emotional, and psychosocial quality of life. Virtual reality gaming has been used for a long time to improve physical fitness, but there have yet to be virtual reality games designed specifically for individuals with SCI. The explicit aim of this research is therefore to develop a therapeutic technology that will be widely accessible to individuals with SCI. What persons with SCI and/or their caregivers will it help, and how will it help them? We aim to provide a readily available exercise platform for individuals with SCI, across a spectrum of physical function. Research has shown that individuals with SCI are particularly prone to be physically inactive. The consequences of physical inactivity have been well documented and include negative outcomes in physical, psychological, and social health with reduced quality of life. For the current study, we will refine our existing virtual reality exercise platform, VR-Move with a focus on non ambulatory individuals with bilaterally preserved C6 function. Our focus on using the exercise platform for this cohort of the SCI population is meant to provide a basis for developing and catering to the platform for higher levels of SCI injury (higher quadriplegic). From our previous work with virtual reality interventions in SCI, we recognize that this product can be widely used by individuals across the age spectrum independently of their home environment. What are the potential clinical applications, benefits, and risks? The proposed virtual reality exercise platform, VR-Move, is intended to provide one of the few accessible exercise modalities designed specifically for individuals with SCI and is readily adaptable across the clinical spectrum - including clinic and self-guided home use. There are no known risks associated with this research. How will the pilot clinical trial advance the research findings along the translational spectrum? This project aims to refine and assess timely therapeutic technology with the specific intention of translating study findings into a clinically validated, widely accessible health product that can be deployed and implemented within the home. The project likewise demonstrates collaboration between academia, industry (a veteran-owned business), and veteran SCI communities. Project completion will offer initial validation of a novel health promoting modality (i.e., virtual reality exercise) informed by individuals living with SCI and experts in SCI to be relevant and responsive to specific health/exercise needs of persons living with SCI. Larger clinical trial testing will subsequently inform product commercialization and dissemination. The resulting platform, developed for unattended in-home use, is expected to make a meaningful contribution to SCI health and physical fitness, accessibility, and quality of life. What is the projected time it may take to achieve a person-related outcome? The team is purposefully refining the existing exercise platform, VR-Move, so that it can be easily implemented within people's homes or in clinic settings. Pending findings from the pilot clinical study, this exercise platform would be available immediately to individuals with SCI What are the likely contributions of the proposed research project to advancing the field of SCI research, patient care, and/or quality of life? The proposed study may make significant contributions across several areas. First, it will facilitate fruitful clinical data and basic lines of scientific inquiry regarding the application of the physical activity paradigm. The study will also increase our knowledge regarding the importance of consumer advocate-driven research for individuals with SCI. Second, low-activity following SCI is consistently associated with reduced quality of life among individuals with SCI and their families; access to an inexpensive portable intervention will therefore significantly improve quality of life among those affected by low-activity SCI.

Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) combined with rehabilitation training for the reconstruction of walking in patients with chronic spinal cord injury (SCI) classified as AIS B-D. The main questions it aims to answer are: Does the intervention of EES combined with rehabilitation significantly improve walking capacity? Is the combined intervention a safe approach for this patient population? Researchers will compare participants' functional assessments before EES implantation and at 2, 4, 7, 10, and 13 months post-implantation to evaluate the longitudinal effects. The primary assessments include the Walking Index for Spinal Cord Injury II (WISCI II), the Spinal Cord Independence Measure (SCIM III), and the adverse event. Secondary outcome measures encompass the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), the Functional Independence Measure (FIM), the Modified Ashworth Scale (MAS), the Penn Spasm Frequency Scale, the 10-Meter Walk Test (10mWT), the 6-Minute Walk Test (6minWT), and pain Visual Analogue Scale (VAS) scores. Neurophysiological and imaging evaluations, including electromyography (EMG), motor evoked potentials (MEPs), somatosensory evoked potentials (SEPs), and positron emission tomography-computed tomography (PET-CT), will be conducted preoperatively and at 6 months postoperatively to explore the mechanisms of neuroplasticity. Participants will: Undergo surgical implantation of an EES device. Receive personalized EES parameter programming combined with rehabilitation training (≥2 hours daily) post-operatively. Complete a series of standardized functional and clinical outcome assessments at scheduled follow-up intervals. Undergo scheduled neurophysiological and metabolic imaging studies. Report any adverse events throughout the study duration.

Combined TMS-tSCS for Lower Limb Rehabilitation in Chronic Incomplete SCI

he goal of this clinical trial is to learn if combined brain and spinal cord stimulation using TMS-tSCS can improve leg strength and walking recovery in adults with chronic incomplete spinal cord injury. The main questions it aims to answer are: Does combined TMS-tSCS improve lower limb motor function more than tSCS alone? Is combined TMS-tSCS safe and does it improve walking speed, independence, muscle activity, spasticity, and nerve pathway function? Researchers will compare combined TMS-tSCS with tSCS alone with sham TMS to see if adding brain stimulation leads to better recovery than spinal stimulation alone. Participants will: Attend 32 treatment sessions over 16 weeks. Receive either combined TMS-tSCS or tSCS with sham TMS. Undergo assessments of leg strength, walking speed, daily function, muscle stiffness, muscle activity, and nerve pathway function before and after treatment.

Spasticity in SCI Following Acute Intermittent Hypoxia

This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. It is hypothesized that hypoxia will decrease the reflex threshold of the biceps brachii, indicating an increase in spasticity following the AIH.

The Effectiveness of Transcutaneous Sacral Neuromodulation Techniques-Magnetic Stimulation and Electrical Stimulation-on Detrusor Overactivity in Patients With Spinal Cord Injury

The goal of this prospective, randomized clinical trial is to compare the efficacy and safety of transcutaneous sacral magnetic stimulation versus sacral electrical stimulation for detrusor overactivity in 40 male and female patients aged 18-65 with suprasacral Spinal Cord Injury (SCI) whose DOA is confirmed by urodynamics and is refractory to anticholinergic medication. The main question(s) aims to answer : Is there a difference between SMS and SES in their effect on objective urodynamic parameters, such as maximum detrusor pressure during filling and bladder compliance? Is there a difference between SMS and SES in reducing the frequency of incontinence episodes and improving the Neurogenic Bladder Dysfunction Score? Researchers will compare Sacral Magnetic Stimulation and Sacral Electrical Stimulation to see if there are differences in their effects on urodynamic measures, clinical symptoms, and patient satisfaction/discomfort. Participants will: Be randomly assigned to one of two intervention groups: Sacral Magnetic Stimulation or Sacral Electrical Stimulation. Receive 20 sessions of the assigned transcutaneous sacral stimulation technique (5 times a week for 20 minutes per session). Undergo a series of evaluations before and after the 20 treatment sessions, including: Urodynamic assessment (cystometry + EMG). Clinical assessments (3-day bladder diary, Neurogenic Bladder Dysfunction Score, Neurogenic Bowel Dysfunction Score, Spinal Cord Independence Measure - SCIM). Patient-reported outcomes (Treatment Satisfaction Level - Likert Scale, Treatment Discomfort Level - Visual Analog Scale)

Fall Prevention Among People With Spinal Cord Injury and Multiple Sclerosis Who Use Wheelchairs and Scooters

The research team is conducting a study to determine if a fall prevention program designed specifically for people who use wheelchairs and scooters can help people better prevent and manage falls compared to the standard of care. This study will compare two groups of participants: 1. One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies. 2. The other group will receive fall prevention information from a well-known program developed by the Centers for Disease Control and Prevention (CDC), called STEADI, which stands for Stopping Elderly Accidents, Deaths, and Injuries. This study includes adults living with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) who use a wheelchair or scooter every day. The research team aims to determine which approach is more effective in reducing falls and improving confidence in performing daily activities.

Epidural Electrical Stimulation in Spinal Cord Injury

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are: Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES. Participants will: Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits. Complete regular motor and sensory function assessments using standardized protocols. Participate in structured rehabilitation training sessions while using the EES device. Report any adverse events and complete quality of life questionnaires at specified follow-up intervals.

Invasive Home Ventilation in Denmark

The aim of this study is to describe national trends over the past 10 years in patients receiving invasive home mechanical ventilation (HMV) in Denmark. This includes indications for invasive HMV, diagnostic groups, and one-year mortality.

Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury

The goal of this clinical study is to determine the feasibility and explore the potential benefits of pelvic floor muscle training during inpatient SCI rehabilitation on urinary, bowel, and sexual function and quality of life in people with SCI. The main questions it aims to answer are: 1. What is the feasibility of recruiting inpatients from SCI rehabilitation to a pelvic floor muscle training program? 2. What is the feasibility and acceptance of the implementation of a pelvic floor muscle training program in SCI inpatient rehabilitation? 3. What are the potential effects of a pelvic floor muscle training program implemented in SCI inpatient rehabilitation on bladder, bowel, and sexual function and quality of life? Participants will be asked to complete a series of assessments (questionnaires, physical assessments) before and after a 6-week intervention of pelvic floor physical therapy.

Virtual Peer Coaching in Manual Wheelchair Skills

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program. First, peer coaches will be enrolled and trained. Then, trainees will be enrolled into one of three interventions: intervention with remote feedback (Group 1), and a wait list control group (Group 2).

High-frequency Alternating Current Stimulation for Neurophatic Pain in Spinal Cord Injury

To investigate the safety and effectiveness of transcutaneous electrical stimulation with 40 kHz alternating currents combined with standard treatment compared to placebo electrical stimulation plus standard treatment for neuropathic pain in people with spinal cord injury.

Health Information for Persons With Spinal Cord Injury

The goal of this pilot study is to design and feasibility test a mobile phone text messaging (SMS) self-management intervention for persons with spinal cord injury (PwSCI). The project will focus on providing a 16-week text messaging intervention on the secondary health conditions of bowel/bladder management, pain, pressure injury, and psychosocial health. Our hopes are to reduce the impact of secondary health conditions (SHC) for PwSCI. The project hopes to test whether the developed self-management program will be feasible and superior to a control group. determine the feasibility and efficacy of the SMS intervention main questions the study aims to answer are: Participants will: Complete an initial assessment Participate in a 16-week text messaging program using their mobile phones Complete 4-week check-ins Complete a post assessment The main question\[s\] it aims to answer \[is/are\]: \[primary hypothesis or outcome measure 1\]? \[primary hypothesis or outcome measure 2\]? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Spatiotemporal tSCS in Spinal Cord Injury

Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.

Self-balancing Personal Exoskeleton for SCI (Site 2)

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

Ultrasonographic Evaluation of Talar Cartilage Thickness in Patients With Spinal Cord Injury

Spinal cord injury patients often present with musculoskeletal comorbidities, including osteoarthritis. Early detection of cartilage damage is important for preventing osteoarthritis progression. This study aims to compare the talar cartilage thicknesses of spinal cord injury patients with healthy subjects. The secondary aim is to investigate a correlation between the talar cartilage thickness and disease-related parameters. The patient group is to be assessed for talar cartilage thickness (via ultrasound), functional status, spasticity, and ambulation levels.

Self-balancing Personal Exoskeleton for SCI

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

Turkish Translation and Content Validity of the Nottwil Environmental Factors Inventory (NEFI) in Persons With Spinal Cord Injury

This observational methodology study will produce a Turkish version of the Nottwil Environmental Factors Inventory (NEFI-TR) within one month using a standardized translation and cultural adaptation process. Content validity will be assessed using an expert panel (and, if applicable, cognitive debriefing with adults with spinal cord injury) to ensure relevance, clarity, and comprehensibility of each item in the Turkish context.

Enhancing Rehabilitation Participation in Patients With SCI/D Using Motivational Interviewing

The purpose of this multi-site clinical trial is to see whether people with spinal cord injury or disorder (SCI/D) demonstrate higher level of participation in rehabilitation sessions and other outcomes when their therapists are trained in a counseling style called motivational interviewing. We want to answer the following questions: 1. Do inpatients with SCI/D treated by physical therapists (PTs) and occupational therapists (OTs) who receive MI training and coaching demonstrate greater therapy participation compared to those treated by therapists who do not receive MI training and coaching? 2. Do inpatients with SCI/D treated by PTs and OTs who receive MI training and coaching demonstrate greater functional improvement at discharge from inpatient rehabilitation and greater community integration at 6 months after discharge compared to those treated by therapists who do not receive MI training and coaching? 3. What are the potential moderators and mediators of the effect of training and coaching on MI skills on therapy participation? Researchers will compare patient participation level and other outcomes of inpatients with SCI/D treated by PTs and OTs who receive MI training and coaching with those treated by therapists who do not receive MI training and coaching. Therapist participants will: 1. Audio record 2 therapy sessions per week with each enrolled SCI patient participant 2. Half of the therapists will attend a 16-hour training on MI skills and 2 practice therapy session Patient participants will: 1. Consent to audio recording of their therapy sessions 2. Complete one brief survey near the time of their discharge and another survey 6 months later

Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI

About 70% of people with a spinal cord injury in Switzerland have chronic pain that lasts more than 3 to 6 months. This pain can be caused by muscle or joint problems, or by nerve damage (neuropathic pain). Neuropathic pain is often hard to treat, and current treatments may cause side effects or not work well. This study will test whether virtual walking from different visual perspectives can reduce chronic neuropathic pain and improve quality of life after spinal cord injury. We will also compare which perspective works best. To better understand how the training works, we will use two tests-quantitative sensory testing (QST) and contact heat-evoked potentials (CHEPs)-to measure changes in the pain and nerve systems.