Clinical Research Directory

Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)

Rehabilitation remains important in the chronic phase after stroke or spinal cord injury, as meaningful improvements may still be achieved through intensive, goal-directed, and personalized training. INTeRAcT-bis is a follow-up study of the original INTeRAcT program, which consisted of a 3-week intensive rehabilitation intervention (90 therapy hours) combining conventional therapy, goal-directed training, self-management, and advanced rehabilitation technologies. The study has two main objectives: (1) to evaluate the long-term clinical and health economic effects of the original INTeRAcT program, and (2) to assess the clinical effects and implementation of a second intensive rehabilitation period ("boost"). Participants receive a personalized 3-week rehabilitation program targeting upper and/or lower limb impairments based on their individual goals. In addition to clinical and health economic outcomes, the study examines participant experiences and implementation factors to support a broader implementation of intensive rehabilitation in the future.

Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury

The goal of this clinical trial is to learn whether virtual reality (VR)-based hypnotherapy, added to conventional physiotherapy, improves pain, sleep, mood, and quality of life in adults with chronic spinal cord injury. The main questions it aims to answer are: * Does VR-based hypnotherapy added to physiotherapy reduce pain intensity more than physiotherapy alone? * Does it improve neuropathic pain, sleep quality, anxiety and depression, spasticity, and quality of life? Researchers will compare participants who receive VR-based hypnotherapy in addition to physiotherapy with participants who receive physiotherapy alone. Participants will: * Receive a standard physiotherapy and rehabilitation program 5 days a week for 2 weeks (10 sessions). * If assigned to the VR group, also receive an approximately 20-minute VR-based hypnotherapy session after each physiotherapy session, using a VR headset and headphones. * Complete assessments at the start of the study, at the end of the 2-week treatment period, and 2 weeks after treatment ends.

ZEPU-AI1 Gait Robot Training Study (ZEPUAI1RCT)

Walking problems caused by stroke, spinal cord injury, or orthopedic surgery are common and can seriously limit a person's independence. Robotic-assisted gait training devices, which use a computer-controlled system to help patients practice standing and walking, have shown promise in improving strength, balance, and walking ability in other countries. However, this type of technology has not yet been carefully studied in Bangladesh. This study will test a robotic gait training and evaluation device called ZEPU-AI1 in adults aged 19 to 60 years who have difficulty walking due to stroke, incomplete spinal cord injury, or gait problems following surgery. The main goals are to find out whether using this robotic device alongside standard physical therapy is feasible (practical to carry out) and safe, and to explore whether it helps improve walking speed, balance, muscle strength, and daily function compared with standard physical therapy alone. Fifty-one participants took part (32 were originally planned; more were enrolled because additional eligible patients were available). Twenty-five received robot-assisted gait training three times a week for 12 weeks in addition to usual rehabilitation therapy, while 26 received usual rehabilitation therapy alone. Participants were assessed regularly using standard walking, balance, and strength tests over the 12-week period. The results of this study will help doctors and researchers understand whether this robotic technology can be safely and effectively introduced into rehabilitation care in Bangladesh.

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).

Neuromodulation for Metabolic Dysfunction

This study evaluates the use of noninvasive transcutaneous spinal cord stimulation (tSCS) to improve glucose regulation and metabolic function in individuals with and without spinal cord injury (SCI) across a spectrum of metabolic states, including no diabetes, prediabetes, and type 2 diabetes (T2D).

Self-balancing Personal Exoskeleton for SCI

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

A Rehabilitation Data Collection Study in Patients With Spinal Cord Injury

The goal of this observational study is to build a rehabilitation registry for people with spinal cord injury (SCI) in Korea and to create foundational data for predicting patients' long-term function. The main question it aims to answer is: \- Can a person's long-term level of disability and functional status after SCI be predicted by collecting medical and socioeconomic information together? Participants receiving inpatient rehabilitation after a spinal cord injury will: * Complete a first (baseline) survey and standard assessments of daily functioning, walking ability, quality of life, and disability at the time of admission * Complete the same assessments again about 6 months and 12 months after discharge * Provide information on their health, use of medical services, employment, income, and social participation during follow-up

Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation

Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation approach that delivers electrical stimulation to spinal nerve roots through electrodes placed over the spinal cord. TSS may support motor and functional recovery following spinal cord injury (SCI). However, therapeutic potential alone does not establish whether TSS can be feasibly integrated into routine rehabilitation. Clinical implementation introduces practical considerations including clinician training, device setup and operation, time, safety monitoring, acceptability, organizational resources, and compatibility with existing rehabilitation workflows. This study will evaluate the feasibility of integrating TSS into two existing SCI rehabilitation programs at Parkwood Institute: outpatient upper- and lower-extremity functional electrical stimulation (FES) cycling using the Xcite system with TSS functionality, and routine inpatient physiotherapy and occupational therapy using the Stim2Go device. Evaluating TSS across two rehabilitation contexts will identify setting-specific barriers, facilitators, and implementation requirements. The primary objective is to evaluate the feasibility, safety, acceptability, and implementation strategies required to integrate TSS into outpatient FES cycling and inpatient SCI rehabilitation. Secondary objectives are to explore preliminary changes in clinical and functional outcomes and synthesize implementation findings into evidence-informed recommendations for TSS implementation. A multi-methods, multi-intervention case series design will be used. Implementation will be guided by the Active Implementation Frameworks and a Training and Coaching Model. Feasibility will be evaluated using Bowen et al.'s Feasibility Framework and the Theoretical Framework of Acceptability, examining acceptability, demand, implementation, practicality, integration, and limited efficacy. The study will recruit 15 adults with SCI and up to 10 clinicians. Ten patient participants will be recruited from the outpatient FES cycling program and five from inpatient SCI rehabilitation. Up to 10 clinicians who integrate TSS into participant care will also be recruited. Outpatient participants will receive TSS during their regularly scheduled FES cycling sessions for four weeks. TSS will be delivered during routine 30-45-minute cycling sessions one to two times per week, targeting the cervical spine for upper-extremity cycling and lower thoracic/lumbar spine for lower-extremity cycling. Inpatient participants will receive TSS using Stim2Go during routine physiotherapy and occupational therapy for a minimum of four weeks, with a target of at least three TSS-assisted sessions per week. TSS will be embedded within usual rehabilitation activities, including transfer training, pre-gait and mobility training, activity-based therapy, and upper-extremity task-specific training. Primary feasibility outcomes will include recruitment, attrition, intervention adherence, adverse events, and patient and clinician experiences. Following the implementation period, patient participants will complete an acceptability survey and semi-structured interview. Clinicians will complete an acceptability survey and participate in a focus group exploring feasibility, acceptability, barriers, facilitators, and lessons learned from integrating TSS into practice. Exploratory clinical outcomes will also be examined. For outpatient participants, FES cycling outcomes from the four weeks before TSS will be compared descriptively with the four-week TSS period, including session time, distance, asymmetry, time without motor support, energy, power, crank velocity, and stimulation parameters. For inpatient participants, baseline and post-intervention outcomes will assess standing, walking, balance, mobility, endurance, upper- and lower-extremity strength, upper-extremity function when relevant, and independence in daily activities. Quantitative feasibility, demographic, survey, cycling, and clinical data will be summarized descriptively and visually. Individual changes in inpatient clinical outcomes will be interpreted using minimal detectable change values where available. Qualitative interview and focus group data will undergo codebook thematic analysis informed by interpretive description to identify implementation experiences, barriers, facilitators, and recommendations. This study will provide real-world evidence on whether and how TSS can be safely and feasibly incorporated into existing SCI rehabilitation services. Evaluating two devices across inpatient and outpatient contexts will identify practical implementation supports and setting-specific considerations not captured in laboratory-based research. Findings will inform recommendations to support adoption and sustained use of TSS across SCI rehabilitation settings in Canada.

AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke

The goal of this clinical trial is to investigate whether personalized multi-electrode transcutaneous spinal cord stimulation (tSCS), guided by machine learning (ML) and combined with gait training, can improve walking function in people with spinal cord injury or stroke compared with single-electrode tonic stimulation combined with the same training. tSCS is a non-invasive technique that delivers electrical pulses through electrodes placed on the skin over the spine to modulate spinal neural circuits, facilitate the recruitment of lower-limb muscles, and support the recovery of voluntary movements. Conventional tSCS typically uses a single stimulation electrode, which may limit selective recruitment of different muscle groups. This study investigates a personalized multi-electrode approach to selectively recruit specific lower-limb muscle groups and deliver stimulation at appropriate phases of the gait cycle, with the aim of improving walking function. The main questions this study aims to answer are: 1. How do electrode positions and stimulation intensities affect selective muscle recruitment, and how do responses vary between participants and days? 2. Can ML-based optimization identify stimulation settings with selectivity comparable to complete mapping of muscle responses, using fewer tests and less time? 3. Does personalized multi-electrode stimulation, synchronized with specific gait phases, improve walking function more than single-electrode tonic stimulation when both are combined with gait training? The study includes 24 participants (14 with spinal cord injury and 10 with stroke) and consists of two stages. Stage 1 - Characterization of tSCS Selectivity and Stimulation Optimization All participants complete two experimental sessions while lying down. Researchers compare muscle responses to stimulation at a central electrode and at multiple spinal electrode locations. Electrical responses in the leg muscles are recorded using surface electromyography (EMG), and spinal reflexes are assessed using paired electrical pulses. By systematically testing electrode positions and stimulation intensities, researchers build a map of which leg muscles respond to each setting (stimulation landscape). They assess the selective recruitment of different muscle groups, compare stimulation locations, and examine differences between participants and across the two sessions. They also test whether ML-based optimization can find similarly selective settings more efficiently than the complete mapping procedure. Stage 2 - tSCS Combined With Gait Training Participants are randomly assigned to one of two groups: single-electrode or multi-electrode tSCS, both combined with gait training. During spinal cord injury recruitment, the randomization procedure was adapted to better balance participants with different baseline walking abilities across groups. Before each training session, participants lie down for an individualized calibration. An ML-based optimization method uses recorded muscle responses to select electrode positions and stimulation intensities for the subsequent walking session. During walking, the single-electrode group receives continuous stimulation through one selected electrode. In the multi-electrode group, stimulation is delivered through electrodes selected to preferentially recruit different target muscle groups. A predefined walking-cycle model determines when stimulation should be delivered, based on gait phases detected in real time by wearable movement sensors. Both groups complete 20 supervised training sessions over four weeks, including 30 minutes of treadmill walking per session. Walking speed is selected according to each participant's comfort and ability, with therapist adjustments, body-weight support, and physical assistance as needed. Clinical and functional assessments are conducted before the intervention (T0), after the 20 sessions (T1), and at a 30-day follow-up (T2). They examine walking performance, muscle strength, spasticity, balance, and mobility. Additional measurements assess muscle activation, brain activity, and biological markers associated with neuroplasticity. The follow-up assesses whether changes are maintained after training.

Functional Electrical Stimulation Plus High Intensity Interval Training at Home

People living with SCI may experience loss of sensation, movement and regular body function. One way to address these impairments is activity-based therapy (ABT), which includes movement-based activities that promote the muscle-brain connection below the level of injury. A technology often used during ABT is functional electrical stimulation (FES), which is an electrical stimulus applied to nerves or paralyzed muscles through sticky gel pads placed on the skin. The purpose of this multi-method pilot study is to look at the safety, interest in and acceptance of an at-home, virtual training program that combines FES with high intensity interval training (HIIT). Up to 24 individuals with SCI will be enrolled in the study. The study activities will span over 34 weeks, from pre-training tests to the 12-week follow-up tests.

Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation Immediately After Spinal Cord Injury

In the treatment of spinal cord injury (SCI) patients in the hyperacute setting, it is imperative to closely control mean arterial pressure (MAP) to ensure adequate spinal cord perfusion in the absence of properly functioning autonomic innervation. Standards of care in literature have historically been to maintain a mean arterial pressure of 85-90 mmHg for 5-7 days after injury. Currently in the ICU setting, this is typically performed using intravenous vasopressors like norepinephrine. Although effective, vasopressors carry risks including arrhythmias, peripheral ischemia, and prolonged ICU management. Transcutaneous spinal cord stimulation (tSCS) has emerged as an alternative method for blood pressure augmentation in SCI patients, recently completing a clinical trial in chronic SCI patients with incredibly promising results. tSCS has yet to be trialed in the ICU setting, but it is expected that patient response should be similar to the chronic setting. This prospective feasibility study will evaluate whether tSCS can acutely increase MAP in adults with acute traumatic SCI admitted to the ICU. During a single study session, participants will receive transcutaneous stimulation while standard vasopressor therapy is maintained at a constant dose. A neurocritical care physician will be present throughout testing to ensure patient safety and standard clinical management. The primary objective is to determine the feasibility and acute hemodynamic effects of tSCS in this population. Primary outcome measures include change in MAP from baseline and time to hemodynamic response following stimulation. Secondary outcomes include changes in heart rate, stimulation tolerability, adverse events, and participant-reported comfort and overall experience. Data collected from this feasibility study will be used to assess the safety and practicality of implementing tSCS in the hyperacute SCI setting and to inform the design of future clinical trials evaluating tSCS as an adjunct or alternative strategy for blood pressure augmentation in critically ill SCI patients.

Powered Exoskeleton-Assisted Walking in Persons With Spinal Cord Injury

Spinal Cord Injury (SCI) represents a significant health challenge, particularly when it comes to the ability to walk. Among its many consequences, mobility impairment can not only directly impact quality of life but also cause a series of secondary problems, such as urinary tract problems, breathing difficulties, muscle contractures, joint stiffness, and resulting pain. These effects can manifest early, even at a young age, further increasing the physical and psychological burden of those affected. To address these challenges, the use of overground exoskeletons, such as the Ekso Bionics (USA), has attracted growing interest in both scientific research and clinical practice. The Ekso not only offers mobility but also represents a valuable resource for gait training, with potential direct and indirect benefits for the physical health and overall well-being of people with SCI. This study is a multicenter, retrospective, pre-post cohort study with the aim of evaluating the dose-dependent effects of exoskeleton-assisted walking training on level ground on spasticity and functional independence in individuals with spinal cord injury. The sample includes at least 70 participants with SCI underwed at least five sessions of walking training using the Ekso™ exoskeleton. Primary outcomes included changes in spasticity, measured by the aggregated Modified Ashworth Scale (MAS), and functional independence, assessed by the Spinal Cord Independence Measure (SCIM) III. The ultimate aim is therefore to evaluate whether ground-based exoskeleton-assisted gait training effectively reduces spasticity and improves functional independence in individuals with spinal cord injury, as this can support the integration of wearable motorized exoskeleons into standard spinal cord injury rehabilitation protocols.

VR-Integrated C-Mill® Combined With Conventional Therapy in Motor-Incomplete SCI

This study investigates the effects of C-Mill® treadmill training, which integrates virtual reality and gamified tasks, combined with conventional physiotherapy, on walking ability, mobility, functional independence, and health-related quality of life in individuals with motor-incomplete spinal cord injury (iSCI). Participants are adults aged 18 years or older with injury at the T4 level or below, classified as American Spinal Injury Association (ASIA) Impairment Scale grade C or D, and with ICD-10 codes S24.73-S24.77 or S34.70. Individuals with a history of osteoporosis, cardiopulmonary disease, other neurological disorders, joint-related conditions, or concurrent participation in another study are excluded. All participants complete a 4-week integrated rehabilitation program at a specialized spinal cord injury center. The program consists of 10 C-Mill® sessions in addition to conventional physiotherapy, targeting balance, gait, and walking speed through task-specific training and individualized exercises to improve mobility, strength, and functional skills.

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.

NG004 in Spinal Cord Injury Patients

This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004. The trial consists of Part A (the dose escalation) and Part B (the PK-confirmation at 2 dose levels from Part A).

Evaluation of a Home-based AOMI Intervention on Cognitive Function and Depression Among Adults With SCI

The investigators propose a pilot randomized clinical trial to determine if adults with spinal cord injury (SCI) show improved cognitive function and depression following home-based Action Observation and Motor Imagery (AOMI) training. It is hypothesized that the home-based AOMI intervention will show satisfactory feasibility and acceptability. They also hypothesize that AOMI training can be used as a rehabilitative tool for improving cognitive function and depression in adults with SCI, because it engages and strengthens similar neural systems as actual exercise.

Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury

This clinical trial aims to assess the preliminary safety and efficacy of Epidural Electrical Stimulation (EES) therapy in managing lower urinary tract dysfunction in individuals with sub-acute or chronic spinal cord injury (SCI). The study evaluates the therapy's potential to improve urinary function and prevent neurogenic detrusor overactivity, ultimately seeking to enhance quality of life for individuals with SCI.

Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment

This randomized controlled trial aims to: (1) examine the effects of virtual walking intervention on chronic pain (primary outcome), and on depression, stress, anxiety, and quality of life (secondary outcomes) compared with the passive observing video control group in individuals with SMI (primarily spinal cord injury and post-polio); (2) explore the neurological mechanism of virtual walking intervention using the resting-state and task-based electroencephalography (EEG); (3) understand their perceived effects, strengths, and limitations for the virtual walking intervention using semi-structured focus group interviews.

mSCI: Mobile Health App for Veterans With SCI and Caregivers

Caregivers of persons with Spinal Cord Injury (SCI) face increased risk of psychological distress, health problems, reduced quality of life, relationship strain, and restrictions in social and work participation. Military caregivers (Family Caregivers of wounded or disabled Veterans) reported similar negative effects of becoming a caregiver on their physical and mental health. Using results from our previous work in mHealth interventions for individuals with SCI, we developed a dual-target intervention for both individuals with SCI and their caregivers. The overall objective of this research study is to conduct translational research focused on adapting and tailoring the interactive Mobile Health and Rehabilitation (iMHere) 2.0 system to meet the needs of Veterans with SCI and their family caregivers, expanding the psychosocial intervention, and evaluating the feasibility of implementing the iMHere system among Veterans with SCI and their family caregivers.

Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program in a clinical setting. The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.

Implantable Wireless Brain-Computer Interface Systems in Patients With Tetraplegia

Objectives of Study: This trial aims to evaluate the safety and efficacy of an implantable wireless brain-computer interface system in patients with tetraplegia resulting from spinal cord injury.

A Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Wireless Brain-Computer Interface（BCI）System NEO in Patients With Tetraplegia

To evaluate the safety and efficacy of a Minimally Invasive Wireless Implantable Brain-Computer Interface (BCI) System NEO in patients with tetraplegia and to provide a basis for product registration. Through brain-computer interface alternative technology, patients can control the external equipment with brain signals to improve the patient's quality of life.

AI-Guided Predictions of Blood Pressure Dysregulation Using Perfusion Index as a Novel Biomarker in Persons With Spinal Cord Injury

The goal of this clinical trial is to determine if perfusion index (PI) can reliably predict changes in systolic blood pressure (SBP) in persons with spinal cord injury (SCI) during a cool temperature challenge. Participants with SCI can be 18-75 years of age, male or female, neurological level of injury C4-T12, ASIA Impairment Scale (AIS: A or B: motor complete) or gender and healthy age-matched able-bodied (AB) controls. The main question this study aims to answer is: can PI reliably predict change in SBP during a cool temperature challenge? The investigators hypothesize that PI can be used as a biomarker of SBP in persons with SCI. Researchers will compare the relationship of 1) changes in PI and SBP and 2) relationship of changes in other vital signs to SBP, during the cool temperature challenge. The researchers aim to determine if PI can be used as a biomarker of SBP in persons with SCI during a cool temperature challenge (experimental group/arm). Able-bodied controls (control group/arm) will receive the same intervention (cool challenge) as the experimental group. During the study, participants will be asked to wear only shorts and a T-shirt so that their skin can be exposed to the warm and cool temperatures of the 2 rooms. The investigators will put put on non-invasive sensors (taped or attached on the surface of your body) to measure PI, BP, and other vital signs. The investigators will record these measurements while the participant is seated in a wheelchair for 10 minutes in a warm room and up to 90 minutes in a cool room.

Postural Control Mechanism During a Stationary Wheelchair Wheelie

The purpose of this study was to investigate the postural control during a stationary wheelchair wheelie. A group of participants was recruited for this observational study. Participants were asked to perform and maintain the stationary phase of a wheelchair wheelie, during which kinematic and kinetic data were recorded.