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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Indego
Craig Hospital
Englewood, Colorado, United States
Shepherd Center
Atlanta, Georgia, United States
Rehabilitation Institue of Chicago
Chicago, Illinois, United States
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Average Time to Don/Doff Device
Time needed for an individual to don or doff the device.
Time frame: 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.
Time frame: 8 weeks
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 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
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RUSK Rehabilitation Center
New York, New York, United States
Time frame: 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
Time frame: 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
Time frame: 8 weeks