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Active Not Recruiting NCT03504826

Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics

Conditions: Spinal Cord Injuries

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 21
Sponsor: Brooks Rehabilitation

Location: Brooks Rehabilitation Jacksonville Florida

Summary

Locomotor training is an established rehabilitation approach that is beneficial for improving walking function in individuals with spinal cord injuries (SCIs). This approach focuses on repetitive practice and appropriate stepping movements to activate spinal neural networks and promote rhythmic motor output associated with walking. Assistance with stepping movements is often provided by physical therapists and trainers, but this can be costly and difficult to deliver in the cost-constrained U.S. healthcare market. Robotic devices have been used as an alternate method to deliver locomotor training, but current robotic approaches often lack the natural movement variations that characterize normal human stepping. Furthermore, studies to compare locomotor training approaches have not shown any specific benefits of using robotic devices. A new type of robotic device has emerged that uses an individual's muscle activation and stepping movements to control the robot during walking. This adaptive robotic device adjusts to the user's intentions and can assist with stepping during locomotor training in a manner that matches natural human stepping. While this type of adaptive robot has been preliminarily tested, the safety and efficacy of locomotor training using adaptive robotics are not well-established in patients with SCI. This is a critical step to determine if individuals with SCI may benefit from use of this device and for preliminary adoption of this technology. Recent studies have used the Cyberdyne Hybrid Assistive Limb (HAL) to deliver locomotor training and have reported outcomes suggesting that the HAL adaptive robot is safe and efficacious for walking rehabilitation in European SCI patients. Therefore this study will use the HAL adaptive robot to deliver locomotor training. This research is necessary to determine if use of the HAL is potentially beneficial and warranted for use with locomotor training and SCI patients receiving care in the U.S. Results of this study may contribute to the development and implementation of effective walking rehabilitation approaches for people with SCIs.

Eligibility Criteria

Inclusion Criteria: 1. Adults 18 - 80 years old 2. Diagnosed with chronic, sensory or motor incomplete spinal cord injury (ASIA Impairment Scale (AIS) B, C, D), \>1 year post injury 3. Medically stable with no acute illness, infections 4. Obtained physician approval to participate in study procedures 5. Able to walk 10 feet with or without assistance, gait assistive devices and/or orthotics 6. Able to provide informed consent Exclusion Criteria: 1. Additional neurologic conditions such multiple sclerosis, Parkinson's disease, stroke, brain injury 2. Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (\

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Source: ClinicalTrials.gov (NCT03504826). StuddyBuddy aggregates publicly available trial information.