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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indego | Experimental | Indego |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indego | Device | Indego |
|
| 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 |
| 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
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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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:
Tolerate being in an upright standing position (passive or active) without being lightheaded or having a headache.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Hospital | Englewood | Colorado | 80113 | United States | ||
| Shepherd Center |
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Subjects were screened and enrolled at five sites in the United States
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects enrolled in the study used the Indego |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects enrolled in the study used the Indego |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | 8 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects enrolled in the study used the Indego |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruise | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Farris | Parker Hannifin Corporation | (216) 896-3335 | ryan.farris@parker.com |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| Atlanta |
| Georgia |
| 30309 |
| United States |
| Rehabilitation Institue of Chicago | Chicago | Illinois | 60611 | United States |
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States |
| RUSK Rehabilitation Center | New York | New York | 10016 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Level of Injury | Number | participants |
|
| ASIA Impairment Scale Score | A: motor and sensory complete injury B: motor complete and sensory incomplete injury C: motor and sensory incomplete injury; half or more than half of affected muscles are less than grade 3/5 D: motor and sensory incomplete injury; half or more than half of affected muscles are more than grade 3/5 Reference: rehabmeasures.org | Number | participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | meters/second | 4 weeks, 8 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | 8 weeks |
|
|
|
| Primary | Average Time to Don/Doff Device | Time needed for an individual to don or doff the device. | Posted | Mean | Standard Deviation | minutes | 8 weeks |
|
|
|
| Primary | 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. | Posted | Number | percentage | 8 weeks |
|
|
|
| Secondary | 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
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 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 53 |
| 19 |
| 53 |
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Scrape/Cut/Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D014947 | Wounds and Injuries |