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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Indego


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indego<br>Indego | Device: Indego<br>* Indego<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT) | 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. | 8 weeks | 
| Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study | 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. | 4 weeks, 8 weeks | 
| Timed Up and Go (TUG) Test | 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. | 8 weeks | 
| Average Time to Don/Doff Device | Time needed for an individual to don or doff the device. | 8 weeks | 
| Percentage of Subjects That Could Don/Doff the Device Independently | The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Index for Spinal Cord Injury (WISCI-II) Assessment | Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury. 0:unable parallel bars, braces, help of 2 persons,<10m parallel bars, braces, help of 2 persons,10m parallel bars, braces, help of 1 person,10m parallel bars, no braces, help of 1 person,10m parallel bars, braces, no help,10m 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 | 8 weeks | 
| Functional Independence Measure (FIM) Score for Walking Indoors | 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 | 8 weeks | 
| Borg Rating of Perceived Exertion (BRPE) for Walking Indoors | 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 | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCI, Indego, Walking