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Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI). (Indego)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202538
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : December 20, 2016
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Parker Hannifin Corporation

Study Description
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Brief Summary:
This study will evaluate the Indego® device for safety and effectiveness at allowing persons with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI).
Study Start Date : August 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Indego
Indego
 Device: Indego
Indego


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT) [ Time Frame: 8 weeks ]
    Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.

  2. Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study [ Time Frame: 4 weeks, 8 weeks ]
    Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.

  3. Timed Up and Go (TUG) Test [ Time Frame: 8 weeks ]
    Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.

  4. Average Time to Don/Doff Device [ Time Frame: 8 weeks ]
    Time needed for an individual to don or doff the device.

  5. Percentage of Subjects That Could Don/Doff the Device Independently [ Time Frame: 8 weeks ]
    The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.


Secondary Outcome Measures :
  1. Walking Index for Spinal Cord Injury (WISCI-II) Assessment [ Time Frame: 8 weeks ]

    Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.

    0:unable

    1. parallel bars, braces, help of 2 persons,<10m
    2. parallel bars, braces, help of 2 persons,10m
    3. parallel bars, braces, help of 1 person,10m
    4. parallel bars, no braces, help of 1 person,10m
    5. parallel bars, braces, no help,10m
    6. walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m

    8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m

    Reference: rehabmeasures.org


  2. Functional Independence Measure (FIM) Score for Walking Indoors [ Time Frame: 8 weeks ]

    FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.

    7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance

    1: total assistance

    Reference: rehabmeasures.org


  3. Borg Rating of Perceived Exertion (BRPE) for Walking Indoors [ Time Frame: 8 weeks ]

    The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.

    6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years or older
  • Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length).
  • Hip width as measured in sitting no greater than 16.6" (42 cm) (acceptable hip width may vary depending on soft tissue).
  • Femur length as measured in sitting must be between 14 inches (35.5cm) and 18.5 inches (47 cm)
  • Weight 250lbs (113.4 kg) or less
  • Present with Spinal Cord Injury and NLI C5 and lower, with ISNCSCI A, B, C or D who are non-ambulatory or poorly ambulatory.
  • There are no restrictions on time since injury. However, each subject must have signed medical clearance/approval for full weight bearing and locomotor training.
  • Determined to have sufficient bone health for walking with full weight bearing without undue risk for fracture. Meeting of this criterion is at the discretion of each subject's personal MD and must be approved by each site's Medical PI.
  • 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 must be intact where it interfaces with robotic device
  • Modified Ashworth Scale for spasticity score must be 3 or less.

  • Blood pressure and heart rate within established guidelines for locomotor training:

    • At rest; Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
    • Exercise; Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less
  • Tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache.

Exclusion Criteria:

  • Weight in excess of 250 lbs
  • Heterotopic ossification that, in the opinion of the investigator, would place the subject at undue risk for fracture.
  • Any subject deemed at increased risk for injury by Medical Personnel
  • Lower extremity joint limitation that exceeds 10 degrees at their hips, knees or ankles.
  • Light headedness or headache in standing position (active or passive)
  • Moderate to Severe Traumatic (or Acquired) Brain Injury
  • Inability to follow instructions
  • Colostomy bag
  • Women who are pregnant or attempting to become pregnant during the study intervention.
  • Unable to obtain informed consent (either from the subject or from the subjects Legally Authorized Representative).
  • Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
  • Unlikely to be available for follow-up phone call.
  • Any other issue which, in the opinion of the investigators, will make the subject unsuitable for study participation.
Contacts and Locations
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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): NCT02202538


Locations
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United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rehabilitation Institue of Chicago
Chicago, Illinois, United States, 60611
United States, New Jersey
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052
United States, New York
RUSK Rehabilitation Center
New York, New York, United States, 10016
Sponsors and Collaborators
Parker Hannifin Corporation
More Information
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Responsible Party: Parker Hannifin Corporation
ClinicalTrials.gov Identifier: NCT02202538    
Other Study ID Numbers: PH-IND01
First Posted: July 29, 2014    Key Record Dates
Results First Posted: December 20, 2016
Last Update Posted: July 25, 2017
Last Verified: June 2017
Keywords provided by Parker Hannifin Corporation:
SCI
Indego
Walking
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System