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NCT03504826 · ClinicalTrials.gov registry record · NA
Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
A NA study of Spinal Cord Injuries, sponsored by Brooks Rehabilitation.
- Active
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03504826 is a NA study of Spinal Cord Injuries that is active but no longer recruiting, run by Brooks Rehabilitation. The registered enrollment target is 21 participants, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03504826, a NA study of Spinal Cord Injuries, is active but no longer recruiting, sponsored by Brooks Rehabilitation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study 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 st
Conditions Studied
Interventions
- DEVICE Hybrid Assistive Limb (HAL)
Study Locations (1)
Florida
- Brooks Rehabilitation - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2024-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03504826
The ClinicalTrials.gov registry entry for NCT03504826 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61-participant average among 202 other Spinal Cord Injuries trials with a reported enrollment target (66% lower). The listed sponsor is Brooks Rehabilitation, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Spinal Cord Injuries appearing as the primary indexed condition, and to 1 intervention - of which Hybrid Assistive Limb (HAL) is the first listed.
NCT03504826 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03504826 about?
NCT03504826 is a clinical study titled "Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics". 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 moto...
What is the current status of trial NCT03504826?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2018-11-29. Estimated completion is 2024-12.
What conditions does trial NCT03504826 study?
This clinical trial studies the following conditions: Spinal Cord Injuries.
What interventions are being tested in trial NCT03504826?
The interventions under investigation include: Hybrid Assistive Limb (HAL) (DEVICE).
Who is sponsoring clinical trial NCT03504826?
This trial is sponsored by Brooks Rehabilitation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03504826 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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