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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Indego||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- 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.
- 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.
- Average Time to Don/Doff Device [ Time Frame: 8 weeks ]Time needed for an individual to don or doff the device.
- 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.
- 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.
- 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
- 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
- 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
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
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|United States, Georgia|
|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|