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Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training

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ClinicalTrials.gov Identifier: NCT03057652
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Shuo-Hsiu Chang, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 20, 2017
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE March 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Change in over ground gait speed as assessed by the 10 Meter Walk Test without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed.
  • Change in walking endurance as assessed by the 6 Minute Walk Test without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes.
  • Change in muscle activity as assessed by electromyography (EMG) during 10MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT.
  • Change in muscle activity as assessed by electromyography (EMG) during 6MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT.
  • Change in energy expenditure as assessed by oxygen consumption during 10MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT.
  • Change in energy expenditure as assessed by oxygen consumption during 6MWT without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT.
  • Change in gait kinematics as assessed by lower extremity joint excursion without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.
  • Change in gait kinematics as assessed by lower extremity joint angular velocities without WRE [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Bone mineral density as assessed by whole body scan [ Time Frame: within one month before start of WRE training ]
    Subjects will undergo whole body bone scan according to standardized protocols.
  • Cognitive impairment as assessed by Folstein Mini Mental State Examination [ Time Frame: within one month before start of WRE training ]
    Folstein Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction.
  • Lower Extremity Muscle Strength as assessed by using a force gauge such as a handheld dynamometer [ Time Frame: within one month before start of WRE training ]
    We will measure lower extremity muscle strength using a force gauge such as a handheld dynamometer.
  • Spasticity as assessed by the Modified Ashworth Scale (MAS) [ Time Frame: within one month before start of WRE training ]
    The Modified Ashworth Scale will be used to measure spasticity in lower limb.
  • Range of motion for lower extremity joints as assessed by manual examination [ Time Frame: within one month before start of WRE training ]
    Range of joint motion of bilateral hip, knee and ankle joints. Subject will lie down on an examination table.
  • Stability during the maximum distance an individual can reach forward from a seated position as assessed by Modified Functional Reach (MFR) [ Time Frame: within one month before start of WRE training ]
    Assesses a patient's stability by measuring the maximum distance an individual can reach forward from a seated position.
  • Walking ability in ambulatory individuals with SC as assessed by Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI): [ Time Frame: within one month before start of WRE training ]
    Assesses functional walking ability in ambulatory individuals with SCI.
  • Amount of physical assistance needed for walking following paralysis resulted from SCI as assessed by Walking Index of Spinal Cord Injury (WISCI-II) [ Time Frame: within one month before start of WRE training ]
    This test is performed by SCI population.
  • Motor recovery after stroke as assessed by Fugl-Meyer Assessment [ Time Frame: within one month before start of WRE training ]
    Evaluates and measures recovery in post-stroke hemiplegic individuals.
  • Confidence in performing various ambulatory activities as assessed by Activities-Specific Balance Confidence Scale [ Time Frame: within one month before start of WRE training ]
    Measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. This is performed in ABI and MS population.
  • User feedback as assessed by a questionnaire [ Time Frame: within one month before start of WRE training ]
    A questionnaire will be administered to allow participants to provide feedback regarding their experiences during intervention.
  • Over ground gait speed as assessed by the 10 Meter Walk Test while wearing WRE [ Time Frame: within one month before start of WRE training ]
    The 10 Meter Walk Test (10MWT) will assess subject's self-selected gait speed. After WRE training has been completed, subjects will perform 10MWT while ambulating in the WRE.
  • Change in walking endurance as assessed by the 6 Minute Walk Test while wearing WRE [ Time Frame: within one month before start of WRE training ]
    The 6 Minute Walk Test (6MWT) assesses the distance walked in 6 minutes. After WRE training has been completed, subjects will perform 6MWT while ambulating in the WRE.
  • Change in muscle activity as assessed by electromyography (EMG) during 10MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 10MWT. After WRE training has been completed, subjects will be assessed by EMG during the 10MWT while ambulating in the WRE.
  • Change in muscle activity as assessed by electromyography (EMG) during 6MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Surface EMG sensors will be placed on the skin of subjects' lower extremities during 6MWT. After WRE training has been completed, subjects will be assessed by EMG during the 6MWT while ambulating in the WRE.
  • Change in energy expenditure as assessed by oxygen consumption during 10MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 10MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.
  • Change in energy expenditure as assessed by oxygen consumption during 6MWT while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2). This task will be performed during the 6MWT. After WRE training has been completed, oxygen consumption will be assessed in subjects during the 10MWT while ambulating in the WRE.
  • Change in gait kinematics as assessed by lower extremity joint excursion while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.
  • Change in gait kinematics as assessed by lower extremity joint angular velocities while wearing WRE [ Time Frame: within one month before start of WRE training ]
    Infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using motion capture system. After WRE training has been completed, subjects will be assessed while ambulating in the WRE.
  • Change in H-reflex of soleus muscle as assessed by electromyography (EMG) [ Time Frame: within one week before start of WRE training, within 2 weeks after start of WRE training ]
    The tibialis nerve will be stimulated, and the size of each H-reflex will be measured as the peak-to-peak amplitude of the non-rectified EMG trace.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Official Title  ICMJE Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training
Brief Summary The purpose of this study is to develop an algorithmic-based evaluation and treatment approach for wearable robotic exoskeleton (WRE) gait training for patients with neurological conditions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Each of the participants will receive training with each of the 3 wearable robotic exoskeletons (WRE) examined in this study, and the order of receipt will be randomized.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Complete Spinal Cord Injury
  • Incomplete Spinal Cord Injury
  • Acquired Brain Injury
  • Multiple Sclerosis
Intervention  ICMJE
  • Device: ReWalk

    ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

    ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.

  • Device: EKSO

    EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

    EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.

  • Device: REX

    REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.

    REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours.

Study Arms  ICMJE
  • Experimental: ReWalk, then EKSO, then REX
    Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
    Interventions:
    • Device: ReWalk
    • Device: EKSO
    • Device: REX
  • Experimental: ReWalk, then REX, then EKSO
    Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
    Interventions:
    • Device: ReWalk
    • Device: EKSO
    • Device: REX
  • Experimental: EKSO, then ReWalk, then REX
    Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
    Interventions:
    • Device: ReWalk
    • Device: EKSO
    • Device: REX
  • Experimental: EKSO, then REX, then ReWalk
    Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
    Interventions:
    • Device: ReWalk
    • Device: EKSO
    • Device: REX
  • Experimental: REX, then EKSO, then ReWalk
    Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
    Interventions:
    • Device: ReWalk
    • Device: EKSO
    • Device: REX
  • Experimental: REX, then ReWalk, then EKSO
    Subjects will be asked to complete a screening visit, baseline and post assessment for each intervention training (ReWalk, EKSO, REX) and up to 15 training sessions per device.
    Interventions:
    • Device: ReWalk
    • Device: EKSO
    • Device: REX
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: February 15, 2017)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Spinal Cord Injury Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Chronic (> 6 mo post) injury
  • Diagnosis of spinal cord injury
  • Able to achieve adequate fit within exoskeleton
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Weight <220 pounds
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Ability to perform informed consent
  • Cognitively intact and able to follow directions and demonstrate learning capability

Spinal Cord Injury Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Diagnosis of other neurological injury other than SCI such as CVA, MS, ABI, CP
  • Uncontrolled spasticity (≥3 on Modified Ashworth Scale)[21]
  • Colostomy
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Uncontrolled autonomic dysreflexia
  • Unresolved deep vein thrombosis
  • Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions
  • Pressure sores, impaired skin integrity

Acquired Brain Injury(ABI) Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Chronic (> 6 mo post) injury
  • Able to achieve adequate fit within exoskeleton
  • Ability to perform informed consent
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Weight <220 pounds
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Cognitively intact and able to follow directions and demonstrate learning capability

Acquired Brain Injury(ABI) Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Diagnosis of other neurological injury other than ABI such as SCI, MS, TBI, CP
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  • Pressure sores, impaired skin integrity
  • Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
  • Colostomy
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions
  • Unresolved deep vein thrombosis

Multiple Sclerosis (MS) Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Chronic (> 6 mo post) injury
  • Diagnosis of multiple sclerosis
  • Ability to perform informed consent
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Weight <220 pounds
  • Able to achieve adequate fit within exoskeleton
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Cognitively intact and able to follow directions and demonstrate learning capability

Multiple Sclerosis (MS) Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
  • Uncontrolled autonomic dysreflexia
  • Unresolved deep vein thrombosis
  • Pressure sores, impaired skin integrity
  • Uncontrolled spasticity (≥3 on Modified Ashworth Scale)
  • Colostomy
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions[23,24]
  • Diagnosis of other neurological injury other than MS such as CVA, SCI, ABI, CP
  • MS Relapse in 3 months prior to recruitment

Able Bodied Inclusion Criteria:

  • Male or non-pregnant female
  • ≥18 years of age
  • Weight <220 pounds
  • Cognitively intact and able to follow directions and demonstrate learning capability[23]
  • Healthy individuals with no history or diagnosis of neurological injury
  • Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
  • Able to achieve adequate fit within exoskeleton
  • Intact skin on all surfaces in contact with device and load bearing surfaces
  • Ability to perform informed consent[24]

Able Bodied Exclusion Criteria:

  • Pregnancy
  • Spinal instability
  • Non-English speaking
  • Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs
  • Diagnosis of neurological injury such as CVA, SCI, ABI, CP, MS
  • Decreased range of motion or contractures in legs (>10° at hips, knees or ankles)
  • Severe comorbidities: active infections, heart, lung, or circulatory conditions
  • Colostomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shuo-Hsiu Chang, PT, PhD 713-799-7016 shuo-hsiu.chang@uth.tmc.edu
Contact: Ruta Paranjape, MS, CCRP 713-799-6976 Ruta.Paranjape@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057652
Other Study ID Numbers  ICMJE HSC-MS-15-0923
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shuo-Hsiu Chang, 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: Shuo-Hsiu Chang, PT, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date March 2021

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