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Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1)

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ClinicalTrials.gov Identifier: NCT03082898
Recruitment Status : Recruiting
First Posted : March 17, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Goldfarb, Vanderbilt University

Brief Summary:
The proposed study is intended to inform the hypotheses that (1) regular dosing of exoskeleton walking will provide health benefits to non-ambulatory and poorly-ambulatory individuals with SCI, including decreased pain and spasticity, improvements in bowel and bladder function, decreased body-mass index (BMI), enhanced well-being; (2) regular dosing of exoskeleton walking will facilitate neurological or functional recovery in some individuals with SCI, particularly those with incomplete injuries; and (3) the level of mobility enabled by a lower limb exoskeleton is commensurate with the walking speeds, distances, and surfaces required for community ambulation.

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

Detailed Description:
Study Outline Study 1, as described herein, will assess the three hypotheses, i.e., health benefit, neurological recovery, and mobility benefits, in the context of regular dosing of exoskeleton walking in a clinical setting. These studies will be conducted at three study sites, Vanderbilt University Medical Center in Nashville TN, the James A. Haley Veterans Hospital in Tampa FL, and the Mayo Clinic in Rochester MN. All study sites will conduct an identical study protocol. The study will involve 24 non-ambulatory and poorly-ambulatory individuals with incomplete and complete SCI (i.e., 8 subjects at each site). In this study, "poorly ambulatory" is defined as persons with functional independence measure (FIM) gait score of 2 to 6 who may be able to walk short distances with or without braces and 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. Of the 24 individuals, half will be individuals with motor-complete injuries (i.e., American Spinal Injury Association Injury Scale, AIS, A or B), and half with motor-incomplete injuries (i.e., AIS C or D). As described subsequently in the Study Procedures section, the study will assess the therapeutic and functional effects of exoskeleton walking over an 8-week period of treatment, where the treatment consists of 3 walking sessions per week, each approximately 1.5 hours in duration for a total of 24 walking sessions. Therapeutic effects will be assessed via a number of measurements recorded primarily at study start, at the 4-week study midpoint, at the 8-week completion of treatment, and in a follow-up session, 8 weeks following the conclusion of treatment. Among the primary measurements to be used to assess secondary health benefits are dual-energy X-ray absorptiometry scans (DXA) to assess bone mineral density (BMD); Modified Ashworth scale (MAS) ratings and Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) to assess effect on spasticity; body mass to assess BMI; and a self-report questionnaire to assess effect on pain, spasticity, bowel and bladder function, skin, and well-being. Neurological effects for non-ambulatory subjects will be assessed via neurological examination and the functional reach (FR) test. Neurological effects for poorly-ambulatory subjects will additionally be assessed via the Functional Independence Measure gait score (FIM-G), the Walking Index for Spinal Cord Injury II (WISCI-II), the Ten Meter Walk Test (10MWT), and the Timed Up and Go (TUG) test, all measured while the subject is not wearing the exoskeleton. The level of mobility provided by the exoskeleton for both motor-complete and motor-incomplete injuries will be assessed by use of the FIM-G, WISCI-II, 10MWT, Six-Minute Walk Test (6MWT), TUG test, and Borg Rating of Perceived Exertion (BRPE), all measured while the subject is wearing the exoskeleton.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1)
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: AIS A or B using Indego Exoskeleton
Patients with American Spinal Injury Association Injury Scale (AIS) A or B (non- ambulatory) will receive regular dosing of exoskeleton walking.
Device: Indego Exoskeleton
Regular dosing of Indego Exoskeleton walking.

Experimental: AIS C or D using Indego Exoskeleton
Patients with American Spinal Injury Association Injury Scale (AIS) C or D (Poorly ambulatory) will receive regular dosing of exoskeleton walking.
Device: Indego Exoskeleton
Regular dosing of Indego Exoskeleton walking.




Primary Outcome Measures :
  1. Ten meter walk test [ Time Frame: 18 weeks ]
    Measure of mobility (specifically gait speed) while wearing exoskeleton

  2. Six minute walk test [ Time Frame: 18 weeks ]
    Measure of gait speed over six minutes while wearing exoskeleton

  3. WICSI-II [ Time Frame: 18 weeks ]
    Assessment of physical assistance required during walking while wearing exoskeleton

  4. FIM gait score [ Time Frame: 18 weeks ]
    Assessment of physical assistance required during walking while wearing exoskeleton


Secondary Outcome Measures :
  1. Timed up and go test [ Time Frame: 18 weeks ]
    Measure of ability to stand, walk, turn, and sit while wearing exoskeleton

  2. Borg perceived exertion [ Time Frame: 18 weeks ]
    Measure of exertion required while using exoskeleton

  3. Modified Ashworth score [ Time Frame: 18 weeks ]
    Measure of spasticity

  4. Bone mineral density [ Time Frame: 18 weeks ]
    Measure of bone mineral density

  5. Functional reach [ Time Frame: 18 weeks ]
    Measure of core strength

  6. Manual muscle test (for poorly ambulatory and incomplete SCI) [ Time Frame: 18 weeks ]
    Measure of muscle strength

  7. Ten meter walk test without exoskeleton (for poorly ambulatory only) [ Time Frame: 18 weeks ]
    Measure of walking speed without exoskeleton

  8. FIM gait score without exoskeleton (for poorly ambulatory only) [ Time Frame: 18 weeks ]
    Measure of assistance required for walking without exoskeleton

  9. WISCI-II score without exoskeleton (for poorly ambulatory only) [ Time Frame: 18 weeks ]
    Measure of assistance required for walking without exoskeleton

  10. Timed up and go test (for poorly ambulatory only) [ Time Frame: 18 weeks ]
    Measure of ability to stand, walk, turn, and sit, without exoskeleton


Other Outcome Measures:
  1. SCI-SET [ Time Frame: 18 weeks ]
    Survey of severity of spasticity

  2. Self-report survey [ Time Frame: 18 weeks ]
    Survey of pain, spasticity, bowel and bladder function, and quality of life

  3. ASIA exam [ Time Frame: 18 weeks ]
    Measure of neurological injury level and classification



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).
  • Non-ambulatory or poorly-ambulatory. In this study, "non-ambulatory" is defined as a person who cannot walk, or is classified with a Functional Independence Measure (FIM) Gait score 1; "poorly ambulatory" is 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 a appropriate stability aids, such as a rolling walker or forearm crutches, during exoskeleton walking.
  • Present with SCI and NLI C5 or lower, with AIS A, B, C or D (as per the International Standard for Neurological Classification of SCI, ISNCSCI), who are non-ambulatory or poorly ambulatory.
  • 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.
  • Blood pressure and heart rate within established guidelines for locomotor training:
  • At rest: systolic 150 mmHg or less, diastolic 90 mmHg or less, heart rate 105 bpm or less.
  • During exercise: systolic 180 mmHg or less, diastolic 105 mmHg or less, heart rate 145 bpm or less.
  • Ability to tolerate an upright standing position for 20 min, passive or active, without being lightheaded or having a headache.
  • Sufficient responsiveness to FES in the quadriceps, hamstrings, tibialis anterior, and gastrocnemius, as defined by MMT in response to stimulation of 3 or greater on a 5-point MMT scale. Note that this is specifically for Study 2, but is included in Study 1 in order to economize study resources regarding enrollment, training, and assessment, as previously discussed.
  • Access to a wireless internet connection. Note that is required only for Study 3, but is included in Study 1 in order to economize study resources regarding enrollment, training and assessment, as previously discussed.

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): NCT03082898


Contacts
Contact: Sheri L. Dixon, BSN 615-343-0266 sheri.dixon@vanderbilt.edu

Locations
United States, Florida
Tampa VA Not yet recruiting
Tampa, Florida, United States, FL 33637-1022
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
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tyson Scrabeck    507-538-1016    Scrabeck.Tyson@mayo.edu   
Contact: Zachary D Zhao    507-284-2262    pohlkamp.zachary@mayo.edu   
Principal Investigator: Kristin D. Zhao, PhD         
Principal Investigator: Megan Gill, DPT         
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Christina M Durrough, PT, DPT, NCS    615-936-5055    christina.m.durrough@Vanderbilt.Edu   
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
Principal Investigator: Michael Goldfarb, MD Vanderbilt University

Responsible Party: Michael Goldfarb, Professor Of Physical Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT03082898     History of Changes
Other Study ID Numbers: SC140121
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries