Spinal Cord Injury
Conditions
Keywords
SCI, Indego, Walking
Brief summary
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.
Interventions
DEVICEIndego
Indego
Sponsors
Parker Hannifin Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects That Could Don/Doff the Device Independently | 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. |
| Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study | 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 | 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 | 8 weeks | Time needed for an individual to don or doff the device. |
| Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure (FIM) Score for Walking Indoors | 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 |
| Borg Rating of Perceived Exertion (BRPE) for Walking Indoors | 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 |
| Walking Index for Spinal Cord Injury (WISCI-II) Assessment | 8 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at five sites in the United States
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects enrolled in the study used the Indego | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet all inclusion criteria | 2 |
| Overall Study | Investigator Decision | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 13 |
| ASIA Impairment Scale Score A | 36 participants |
| ASIA Impairment Scale Score B | 5 participants |
| ASIA Impairment Scale Score C | 11 participants |
| ASIA Impairment Scale Score D | 1 participants |
| Level of Injury L1 | 2 participants |
| Level of Injury L2 | 1 participants |
| Level of Injury T10 | 7 participants |
| Level of Injury T11 | 5 participants |
| Level of Injury T12 | 5 participants |
| Level of Injury T3 | 3 participants |
| Level of Injury T4 | 9 participants |
| Level of Injury T5 | 6 participants |
| Level of Injury T6 | 5 participants |
| Level of Injury T7 | 3 participants |
| Level of Injury T8 | 6 participants |
| Level of Injury T9 | 1 participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
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.
Time frame: 4 weeks, 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study | Average speed for 10MWT mid study | 0.31 meters/second | Standard Deviation 0.1 |
| All Enrolled Subjects Who Completed the Study | Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study | Average speed for 10MWT end of study | 0.37 meters/second | Standard Deviation 0.09 |
Primary
Average Time to Don/Doff Device
Time needed for an individual to don or doff the device.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Average Time to Don/Doff Device | Average time to don device | 9.3 minutes | Standard Deviation 4.5 |
| All Enrolled Subjects Who Completed the Study | Average Time to Don/Doff Device | Average time to doff device | 2.6 minutes | Standard Deviation 1.4 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Enrolled Subjects Who Completed the Study | Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT) | 95.6 percentage of participants |
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Percentage of Subjects That Could Don/Doff the Device Independently | Subjects that could don device independently | 62.2 percentage |
| All Enrolled Subjects Who Completed the Study | Percentage of Subjects That Could Don/Doff the Device Independently | Subjects that could doff device independently | 82.2 percentage |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Timed Up and Go (TUG) Test | 84.09 seconds | Standard Deviation 20.41 |
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
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Borg Rating of Perceived Exertion (BRPE) for Walking Indoors | 10.4 units on a scale | Standard Deviation 2.2 |
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
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Functional Independence Measure (FIM) Score for Walking Indoors | 4.3 units on a scale | Standard Deviation 0.5 |
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 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
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Subjects Who Completed the Study | Walking Index for Spinal Cord Injury (WISCI-II) Assessment | 6.8 units on a scale | Standard Deviation 1.5 |