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Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons

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ClinicalTrials.gov Identifier: NCT03011099
Recruitment Status : Completed
First Posted : January 5, 2017
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Edward Davis, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 5, 2017
Results First Submitted Date  ICMJE April 22, 2017
Results First Posted Date  ICMJE April 3, 2018
Last Update Posted Date April 3, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test [ Time Frame: baseline, week 4 ]
    The 10 Meter Walk Test assesses the time taken to walk 10 meters.
  • Change in Walking Endurance as Assessed by the 6 Minute Walk Test [ Time Frame: baseline, week 4 ]
    The 6 Minute Walk Test assesses the distance walked in 6 minutes.
  • Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test [ Time Frame: baseline, week 4 ]
    The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
  • Change in Muscle Activity as Assessed by Surface Electromyography (EMG) [ Time Frame: baseline, week 4 ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.
  • Change in Energy Expenditure During Walking as Assessed by Oxygen Cost [ Time Frame: baseline, week 4 ]
    Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test [ Time Frame: baseline, week 4 ]
    The 10 Meter Walk Test assesses the time taken to walk 10 meters.
  • Change in Walking Endurance as Assessed by the 6 Minute Walk Test [ Time Frame: baseline, week 4 ]
    The 6 Minute Walk Test assesses the distance walked in 6 minutes.
  • Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test [ Time Frame: baseline, week 4 ]
    The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
  • Change in Muscle Activity as Assessed by Surface Electromyography (EMG) [ Time Frame: baseline, week 4 ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity.
  • Change in Energy Expenditure During Walking as Assessed by Oxygen Cost [ Time Frame: baseline, week 4 ]
    Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
Change History Complete list of historical versions of study NCT03011099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) [ Time Frame: baseline, week 4 ]
    Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
  • Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length) [ Time Frame: baseline, week 4 ]
    Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
  • Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time) [ Time Frame: baseline, week 4 ]
    Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
  • Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) [ Time Frame: baseline, week 4 ]
    The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range: 0 = total paralysis
    1. = palpable or visible contraction
    2. = active movement, full range of motion (ROM) with gravity eliminated
    3. = active movement, full ROM against gravity
    4. = active movement, full ROM against gravity and moderate resistance in a muscle specific position
    5. = (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person
    We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.
  • Exoskeleton User Feedback as Assessed by a Questionnaire [ Time Frame: week 4 ]
    A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2017)
  • Change in gait characteristics as assessed by the GAITRite Walkway [ Time Frame: baseline, week 4 ]
    Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry.
  • Change in lower extremity strength as assessed by American Spinal Injury Association (ASIA) lower extremity motor score [ Time Frame: baseline, week 4 ]
    The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury.
  • Change in exoskeleton user feedback as assessed by a questionnaire [ Time Frame: week 4 ]
    A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Official Title  ICMJE Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Brief Summary The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Device: Robotic exoskeleton training
    During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
  • Other: Conventional physical therapy
    During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
Study Arms  ICMJE
  • Experimental: Robotic exoskeleton training
    During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
    Intervention: Device: Robotic exoskeleton training
  • Active Comparator: Conventional Physical Therapy
    During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
    Intervention: Other: Conventional physical therapy
Publications * Chang SH, Afzal T; TIRR SCI Clinical Exoskeleton Group, Berliner J, Francisco GE. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018 Mar 5;4:62. doi: 10.1186/s40814-018-0247-y. eCollection 2018.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
  • Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
  • Male or non-pregnant woman
  • ≥ 18-years of age
  • At least 6 months after injury
  • Height between 5'2" and 6'2" (150-188 cm)
  • Weight ≤ 220 pounds (100 kg)
  • Ability to perform informed consent

Exclusion Criteria:

  • Presence of clinical signs of lower motor neuron injury
  • History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
  • Documented severe osteoporosis affecting the hip and spine
  • Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
  • Unstable spine
  • Unhealed limb or pelvic fractures
  • Skin issues that would prevent wearing the device
  • Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
  • Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
  • Heterotopic ossification that resists functional range of motion in lower extremities
  • Contractures (>15 degrees at the hips or >20 degrees at the knees)
  • Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
  • Colostomy
  • Have received any physical therapy intervention within 3 months prior to enrolment in the study
  • Non-English speaking
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03011099
Other Study ID Numbers  ICMJE HSC-MS-13-0536
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Edward Davis, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew Davis, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date March 2018

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