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Trial record 13 of 29 for:    Spinal Cord Injuries | ( Map: Minnesota, United States )

Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149769
Recruitment Status : Not yet recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Goldfarb, Vanderbilt University

Brief Summary:
The proposed study is a pilot study intended to inform the hypothesis that regular walking in an exoskeleton within the home and community might offer health benefit, neurological recovery, and/or mobility benefit to the user. This exploratory pilot study is also intended to assess the level of compliance (i.e., exoskeleton use) among study participants by characterizing extent the device is used beyond the minimum required.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Device: Indego Exoskeleton Not Applicable

Detailed Description:
Study 3 Outline Study 3 enrollment will be limited to 1 or 2 subjects at each site. Each subject will take home an exoskeleton for the 8-week duration of the treatment period. The subjects will be selected from the pool of poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton. Note that study 3 will emply the exoskeleton as per existing FDA approval (510(k) number K171334); specifically, "to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions [in the home and community] with supervision of a specially trained companion in accordance with the user assessment and training certification program." Use of the exoskeleton in the home and community (i.e., outside a clinical setting) is referred to as "personal use." So that this study complies with FDA approval for personal use, subjects selected for enrollment in Study 3, along with each subject's designated support person, will be trained and certified for personal use in accordance with the manufacturer's FDA-approved personal use training program.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Home and Community Setting (SC140121 Study 3)
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Interventional
Walking in an exoskeleton within the home and community.
Device: Indego Exoskeleton
Regular dosing of Indego Exoskeleton walking.




Primary Outcome Measures :
  1. Ten meter walk test (10MWT) [ Time Frame: 18 weeks ]
    Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

  2. Six minute walk test (6MWT) [ Time Frame: 18 weeks ]
    Measure of gait speed over six minutes while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

  3. Walking Index for Spinal Cord Injury II (WISCI-II) [ Time Frame: 18 weeks ]
    Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.

  4. Functional Independence Measures (FIM) gait score [ Time Frame: 18 weeks ]
    Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 7 (0= activity does not occur and 7= complete independence


Secondary Outcome Measures :
  1. Timed Up and Go Test (TUG) [ Time Frame: 18 weeks ]
    Measure of ability to stand, walk, turn, and sit while wearing exoskeleton. ≤ to 10 seconds to > 30 seconds (≤ 10 seconds=normal to > 30 predictive of requiring assistive device for ambulation and being dependent in ADLs

  2. Borg Rating Scale of Perceived Exertion (RPE) [ Time Frame: 18 weeks ]
    Measure of exertion required while using exoskeleton. Scale 6 to 20 (6= no exertion and 20 = maximal exertion

  3. Modified Ashworth Score (MAS) [ Time Frame: 18 weeks ]
    Measure of bone mineral density. Scale 0 to 4 (0=No increase in muscle tone and 4=Affected part(s) rigid in flexion or extension)

  4. Bone Mineral Density [ Time Frame: 18 weeks ]
    Measure of bone mineral density. Score -1 and above to -2.5 and below (-1.0 to +0.5= normal and -2.5 and below=osteoporosis)

  5. Functional Reach [ Time Frame: 18 weeks ]
    Measure of core strength. 0 to 3 (0= unable to reach 3=Reach > or = to 10 inches)

  6. Manual Muscle Test (MMT) [ Time Frame: 18 weeks ]
    Measure of muscle strength Scale 0 to 5 (0= No visible or palpable contraction and 5=Full ROM against gravity, maximul resistance

  7. Ten Meter Walk Test without exoskeleton (10MWT) [ Time Frame: 18 weeks ]
    Measure of walking speed without exoskeleton. Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)

  8. Functional Independence Measures (FIM) gait score without exoskeleton [ Time Frame: 18 weeks ]
    Measure of assistance required for walking without exoskeleton Scale 0 to 7 (0= activity does not occur and 7= complete independence

  9. Walking Index for Spinal Cord Injury II (WISCI-II) score without exoskeleton [ Time Frame: 18 weeks ]
    Measure of assistance required for walking without exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.


Other Outcome Measures:
  1. Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) [ Time Frame: 18 weeks ]
    Survey of severity of spasticity. Score -3 to +3 ( -3 (extremely problematic) to +3 (extremely helpful).

  2. Self-Report Survey [ Time Frame: 18 weeks ]
    Survey of pain, spasticity, bowel and bladder function, and quality of life. Pain 0 to 5 (0=no pain and 5 =severe pain. Overall level of pain -3 to 3 (-3 =decreased and 3 =increased) Spasticity 0 to 5 (0= No spasticity and 5 Severe spasticity) Overall level of spasticity -3 to 3 (-3 =decreased and 3 =increased) Changes in bowel habits -3 to 3 (-3 worse and 3=better) Changes in bladder habits -3 to 3 (-3 worse and 3=better) Changes in mood -3 to 3 (-3 worse and 3=better)

  3. American Spinal Injury Association (ASIA) Impairment Scale [ Time Frame: 18 weeks ]
    Measure of neurological injury level and classification. Scale A to E (A= complete and E= normal)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older.
  • Size and limb proportions capable of fitting in the exoskeletal device :
  • Height between 1.55 m (5 ft, 1 in) and 1.92 m (6 ft, 3 in).
  • Femur length between 37.5 cm (15 in) and 43.125 cm (17.25 in).
  • Body mass no greater than 114 kg (250 lb).
  • "Poorly ambulatory" individual, defined as a person with FIM Gait 2- 6, who may be able to walk short distances with or without braces or stability aid, or may be able to walk with assistance of one person, but whose primary means of mobility is a manual or power-operated wheelchair.
  • Sufficient upper extremity strength and coordination to balance using appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
  • Neurological injury level (NLI) T3 to L5 (between and inclusive).
  • Chronic SCI: at least 6 months post-injury, and preferably post-injury more than 1 year.
  • Sufficient bone health for walking with full weight-bearing without undue risk of fracture, as determined by each subject's personal medical doctor, and approved by each site's medical supervisor.
  • Passive range of motion (PROM) at shoulders, trunk, upper extremities and lower extremities within functional limits for safe gait and use of appropriate assistive device/stability aid.
  • Skin intact where interfacing with robotic device.
  • MAS for spasticity score 3 or less in lower extremities.
  • Resting blood pressure and heart rate within established guidelines for locomotor training, specifically systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less.
  • Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.
  • Availability and willingness of support person to be trained in accordance with the FDA training protocol for personal use of the exoskeleton, and who will assume responsibility for the support person role, which specifically includes providing ambulatory support during all exoskeletal walking.
  • Access to a wireless internet connection (for use of exoskeleton iPod device).
  • Willingness and ability to electronically send walking session reports from exoskeleton iPod to appointed site monitor following each walking session.

Exclusion Criteria:

  • Heterotopic ossification that, in the opinion of the site medical supervisor, would place the subject at undue risk for fracture.
  • Inability to follow instructions.
  • Colostomy bag.
  • Women who are pregnant or attempting to become pregnant during the course of the study. Note that a pregnancy test will be required and must be negative for all women prior to enrolling in the study, and will be additionally required and must be negative every four weeks during the course of the study protocol.
  • Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
  • Insufficient availability to complete study.
  • Any other issue which, in the opinion of the investigators or medical supervisor, make the subject unsuitable for study participation.

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): NCT04149769


Contacts
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Contact: Sheri L Dixon, BSN 6153430266 sheri.dixon@vanderbilt.edu

Locations
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United States, Florida
Tampa VA
Tampa, Florida, United States, 33637
Contact: Padmaja Ramaiah, MSBME    813-558-7620    Padmaja.Ramaiah@va.gov   
Contact: Samuel L. Phillips, PhD    (813) 558-3995    Samuel.phillips@va.gov   
Principal Investigator: Samuel L. Phillips, PhD         
United States, Minnesota
Minnesota Mayo Clinic
Rochester, Minnesota, United States, 55905
Contact: Tyson Scrabeck    507-538-1016    scrabeck.Tyson@mayo.edu   
Contact: Julie D Block    507-255-7393    block.julie@mayo.edu   
Principal Investigator: Kristin D. Zhao, PhD         
Sub-Investigator: Megan L. Gill, DPT         
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Contact: Christina M. Durrough, PT, DPT, NCS    615-936-5055    christina.m.durrough@vumc.org   
Contact: Michael Goldfarb, PhD    (615) 343-6924    michael.goldfarb@Vanderbilt.Edu   
Principal Investigator: Michael Goldfarb, PhD         
Sub-Investigator: Gerasimos Bastas, MD, PhD         
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Michael Goldfarb, PhD Vanderbilt University
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Responsible Party: Michael Goldfarb, Professor Of Physical Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT04149769    
Other Study ID Numbers: SC140121 Study 3
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries