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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

Tracking Information
First Submitted Date  ICMJE March 26, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE November 29, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • 10-Meter Walk Test (10MWT) [ Time Frame: Daily and change in baseline to weeks 6, 12, and 20 ]
    Performance assessment of comfortable and fastest safe walking speed for 10 meters
  • 6-Minute Walk Test (6MWT) [ Time Frame: Weekly and change in baseline to weeks 6, 12, and 20 ]
    Performance assessment of walking endurance for 6 minutes.
Change History Complete list of historical versions of study NCT03504826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • American Spinal Cord Injury (ASIA) Impairment Scale [ Time Frame: Baseline to week 12 ]
    Standardized clinical assessment of sensation and strength based on levels of the spinal cord to classify the severity of injury. The test is clinician-administered; clinical examination conducted to test whether sensation is 0-absent; 1-impaired or 2-normal. The lower score the worse the paralysis and the higher the score will indicate the lesser of the paralysis
  • 3-Meter Backward Walk Test (3MBWT) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Performance assessment of backward comfortable walking speed for 3 meters
  • Neuromuscular Recovery Scale (NRS) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Performance assessment of functional motor recovery that includes seated sit up and reverse sit up, sitting ability, trunk extension in sitting, standing ability, walking ability, and sit to stand.
  • Spinal Cord Injury Functional Ambulation Profile (SCI-FAP) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Time it takes to do 7 specific walking tasks: 5 meters on carpet, 5 meters on smooth ground while carrying a bag with weights, timed-up-and-go, up and down one step, up and down 4 steps, walking while opening a door, walking over and around obstacles
  • Functional Reach Test (FRT) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Performance assessment of standing stability by measuring the maximum distance an individual can reach forward while standing in a fixed position
  • Activities Specific Balance (ABC) Confidence Scale [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Questionnaire to assess self-reported balance confidence in varied functional situations such as waling in a parking lot or in the home
  • Modified Ashworth Scale (MAS) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Performance assessment to measure spasticity
  • 30-Second Chair Stand Test (30-s CST) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Performance assessment to measure functional lower limb muscle strength used to move from sitting to/from standing. Measured by the number of repetitions of standing to/from sitting in a 30 second time frame.
  • Trail Making Test [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Performance assessment of attention and executive function
  • Spinal Cord Independence Measure (SCIM) [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Questionnaire to assess self-reported measures of various self-care and mobility items that include: respiratory, bowl, bladder, transfer ability, bed mobility, stairs, and mobility indoors and outdoors.
  • Brief Pain Inventory [ Time Frame: Change in baseline to weeks 6, 12, and 20 ]
    Questionnaire to assess self-reported pain as well as behavioral and psychosocial factors associated with pain
  • 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. The EMG signals will be recorded using a motion capture software to synchronize collection of the EMGs and motion data (kinematics).
  • Measurement of joint motions [ Time Frame: Change in baseline to week 12 ]
    A 12-camera three-dimensional motion analysis system will be used to collect marker data and measure joint kinematics during walking tasks. Small adhesive reflective markers will be placed on the upper and lower extremities, and the trunk, using an established marker set. This will allow for quantification of trunk and lower extremity joint motions during the walking activities. To reduce artifact and improve accuracy of motion analysis data, reflective markers will be placed directly on the skin when possible, and individuals will wear tight, minimal clothing to provide access to bony, anatomical landmarks as able. Infrared motion analysis cameras will be positioned around the testing area, ensuring at least 2 cameras are able to view each reflective marker at all times.
  • Kinetics [ Time Frame: Change in baseline to week 12 ]
    Ground reaction forces (kinetics) will be recorded during the standing and walking activities. The participants will be asked to stand or walk over the standard built-in force plates, which are flush with the floor and are not an obstacle or tripping hazard.
  • Functional near infrared spectroscopy (fNIRS) [ Time Frame: Change in baseline to week 12 ]
    fNIRS may be used to assess brain/neural activity required for the individual to perform the standing and walking tasks assessed during the motion capture biomechanical testing. fNIRS uses non-invasive sensors that are light-emitting diodes to illuminate oxygenated hemoglobin in superficial brain tissue. The sensors are attached to a lightweight strap placed around the forehead to monitor neural activity in the pre-frontal cortex. The data are transmitted wirelessly to a computer to record the data and for future analysis
  • Maximal inspiratory pressure will be used to assess diaphragm strength [ Time Frame: Change in baseline to week 12 ]
    Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test.
  • Maximal expiratory pressure will be used to assess respiratory function [ Time Frame: Change in baseline to week 12 ]
    Respiratory function will be assessed using standard clinical approaches to measure inspiratory and expiratory pressures and volumes as well as standard spirometry. A Friedman's ANOVA will be used to test for differences in the respiratory outcomes across the multiple (4 or more) time points. Post-hoc comparisons will be conducted using a Wilcoxon signed-rank test.
  • Forced Vital Capacity [ Time Frame: Change in baseline to week 12 ]
    The forced vital capacity is an evaluation of how much air a person can forcefully exhale after a maximal inspiratory effort. Tests are conducted using a digital spirometer or respiratory monitor
  • Spatiotemporal movement characteristics [ Time Frame: Change in baseline to week 12 ]
    During the session, the participant may be asked to stand or walk over a 12' instrumented walkway (i.e. GaitRite). The walkway appears like a flat, carpeted surface and has embedded sensors to record foot falls and foot placement.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
Official Title  ICMJE Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Hybrid Assistive Limb (HAL)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504826
Other Study ID Numbers  ICMJE 2017-02655
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brooks Rehabilitation
Study Sponsor  ICMJE Brooks Rehabilitation
Collaborators  ICMJE University of Florida
Investigators  ICMJE
Principal Investigator: Emily J Fox, DPT, PhD Brooks Rehabilitation
PRS Account Brooks Rehabilitation
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP