Indego
DeviceIndego
NCT Number: NCT02202538
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Craig Hospital, Englewood, Colorado, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Indego
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.
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.
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.
Time frame: 8 weeks
Time needed for an individual to don or doff the device.
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.
Time frame: 8 weeks
Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.
0:unable
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
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
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
Parker Hannifin Corporation
Industry
Acronym: Indego
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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