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

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ClinicalTrials.gov Identifier: NCT03504826
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Brooks Rehabilitation

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Hybrid Assistive Limb (HAL) Not Applicable

Detailed Description:

The purpose of this study is to examine the safety and efficacy of locomotor training using adaptive robotics in adults with chronic SCI. Safety will be determined by monitoring of adverse responses such as skin irritation, pain, changes in spasticity and function. Preliminary efficacy for improving walking function will be determined by tests of walking speed and endurance prior to and following 60 daily sessions of locomotor training using adaptive robots.

Specific Aims:

Specific Aim 1: Test the hypothesis that locomotor training using adaptive robotics such as the Cyberdyne Hybrid Assistive Limb (HAL) is safe for individuals with chronic incomplete spinal cord injury (SCI). Safety will be demonstrated by an adverse response rate that does not exceed the frequency and severity of adverse responses reported for other well-established locomotor rehabilitation approaches. Safety will be assessed by monitoring of specific conditions such as skin integrity, pain, and spasticity.

Specific Aim 2: Test the hypothesis that locomotor training using adaptive robotics such as the Cyberdyne HAL (5x/week for 12 weeks, 60 sessions, 2 hours each) is efficacious for improving walking function in adults with chronic incomplete SCIs. Walking function may be assessed using standard clinical tests to measure walking speed and walking endurance. A battery of clinical tests (listed in Outcome Measures) will be selected for use based on each participant's functional capabilities.

To address the aims of the study, the investigators will use a pre-post repeated measures study design. Following phone and in-person screenings and physician approval, individuals will provide informed consent to the study procedures. Non-invasive tests of physical function and health will be conducted prior to and following 60 sessions of locomotor training using the HAL, an adaptive robotic device that is custom fitted to each individual to provide assistance to the lower limbs during locomotor training.

Subject recruitment: Individuals with chronic SCI (>1 year) who meet the given enrollment criteria (see inclusion and exclusion criteria), and who have already been accepted into the Brooks Cybernic Treatment Program for walking rehabilitation, will be included into this study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Locomotor training using adaptive robot
The intervention will consist of 60 sessions of locomotor training using the HAL adaptive robot. The training sessions will be scheduled 5 days per week for 12 weeks. A physical therapist with expertise in SCI walking rehabilitation and use of the HAL will oversee all intervention sessions. The intervention sessions will include up to a total of 40 minutes of stepping time, which may take up to 2 hours to complete due to set up time and rest breaks.
Device: Hybrid Assistive Limb (HAL)
Intensive training with the HAL consisting of two components to the intervention session that include: 1) locomotor treadmill training with the HAL device and 2) locomotor training over ground without the HAL device. All training will be overseen by a licensed physical therapist.




Primary Outcome Measures :
  1. 10-Meter Walk Test (10MWT) [ Time Frame: Daily and change in baseline to weeks 6 and 12 ]
    Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.

  2. 6-Minute Walk Test (6MWT) [ Time Frame: Daily and change in baseline to weeks 6 and 12 ]
    Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.


Secondary Outcome Measures :
  1. Electromyogram (EMG) will be used to assess the neuromuscular activation of the lower extremities [ Time Frame: Change in baseline to week 12 ]
    A wireless, 16-channel EMG system will be applied at various key muscle groups on both lower extremities. Greater amplitude or changes in activation timing in the EMG signal will reflect improvement in muscle activation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (<1 year), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
  3. Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
  4. Lower extremity joint contractures limiting the ability to stand upright and practice walking
  5. Skin lesions or wounds affecting participation in walking rehabilitation
  6. Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
  7. Spasticity or uncontrolled movements limiting participation in walking rehabilitation
  8. Body weight or height that is incompatible with safe use of the HAL and/or use of a support harness and body weight support system
  9. Pain that limits walking or participation in walking rehabilitation
  10. Current participation in rehabilitation to address walking function
  11. Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
  12. Legal blindness or severe visual impairment
  13. Known pregnancy
  14. Pacemaker or medical device implants which may interfere with the use of the HAL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504826


Contacts
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Contact: Emily J Fox, DPT, PhD 352-273-6117 ejfox@phhp.ufl.edu
Contact: Lou DeMark, DPT, NCS 904-345-8968 lou.demark@brooksrehab.org

Locations
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United States, Florida
Brooks Rehabilitation Recruiting
Jacksonville, Florida, United States, 32216
Contact: Emily J Fox, DPT,PhD    352-273-6117    ejfox@phhp.ufl.edu   
Principal Investigator: Emily J Fox, DPT, PhD         
Sub-Investigator: Lou DeMark, DPT, NCS         
Sub-Investigator: Christy Conroy, MSPT, NCS         
Sub-Investigator: David Clark, ScD         
Sub-Investigator: Geneva Jacobs, MD         
Sponsors and Collaborators
Brooks Rehabilitation
University of Florida
Investigators
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Principal Investigator: Emily J Fox, DPT, PhD Brooks Rehabilitation

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Responsible Party: Brooks Rehabilitation
ClinicalTrials.gov Identifier: NCT03504826     History of Changes
Other Study ID Numbers: 2017-02655
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brooks Rehabilitation:
adaptive robotics
locomotor training
Spinal Cord diseases
walking rehabilitation
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System