The proposed study is a pilot study intended to inform the hypothesis that regular walking in an exoskeleton within the home and community might offer health benefit, neurological recovery, and/or mobility benefit to the user. This exploratory pilot study is also intended to assess the level of compliance (i.e., exoskeleton use) among study participants by characterizing extent the device is used beyond the minimum required.
Study 3 Outline Study 3 enrollment will be limited to 1 or 2 subjects at each site. Each subject will take home an exoskeleton for the 8-week duration of the treatment period. The subjects will be selected from the pool of poorly-ambulatory subjects previously enrolled in Studies 1 and/or 2, and as such will have prior experience walking in the exoskeleton. Note that study 3 will emply the exoskeleton as per existing FDA approval (510(k) number K171334); specifically, "to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions \[in the home and community\] with supervision of a specially trained companion in accordance with the user assessment and training certification program." Use of the exoskeleton in the home and community (i.e., outside a clinical setting) is referred to as "personal use." So that this study complies with FDA approval for personal use, subjects selected for enrollment in Study 3, along with each subject's designated support person, will be trained and certified for personal use in accordance with the manufacturer's FDA-approved personal use training program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Regular dosing of Indego Exoskeleton walking.
Tampa VA
Tampa, Florida, United States
Minnesota Mayo Clinic
Rochester, Minnesota, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ten meter walk test (10MWT)
Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)
Time frame: 18 weeks
Six minute walk test (6MWT)
Measure of gait speed over six minutes while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)
Time frame: 18 weeks
Walking Index for Spinal Cord Injury II (WISCI-II)
Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.
Time frame: 18 weeks
Functional Independence Measures (FIM) gait score
Assessment of physical assistance required during walking while wearing exoskeleton. Scale 0 to 7 (0= activity does not occur and 7= complete independence
Time frame: 18 weeks
Timed Up and Go Test (TUG)
Measure of ability to stand, walk, turn, and sit while wearing exoskeleton. ≤ to 10 seconds to \> 30 seconds (≤ 10 seconds=normal to \> 30 predictive of requiring assistive device for ambulation and being dependent in ADLs
Time frame: 18 weeks
Borg Rating Scale of Perceived Exertion (RPE)
Measure of exertion required while using exoskeleton. Scale 6 to 20 (6= no exertion and 20 = maximal exertion
Time frame: 18 weeks
Modified Ashworth Score (MAS)
Measure of bone mineral density. Scale 0 to 4 (0=No increase in muscle tone and 4=Affected part(s) rigid in flexion or extension)
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Time frame: 18 weeks
Bone Mineral Density
Measure of bone mineral density. Score -1 and above to -2.5 and below (-1.0 to +0.5= normal and -2.5 and below=osteoporosis)
Time frame: 18 weeks
Functional Reach
Measure of core strength. 0 to 3 (0= unable to reach 3=Reach \> or = to 10 inches)
Time frame: 18 weeks
Manual Muscle Test (MMT)
Measure of muscle strength Scale 0 to 5 (0= No visible or palpable contraction and 5=Full ROM against gravity, maximul resistance
Time frame: 18 weeks
Ten Meter Walk Test without exoskeleton (10MWT)
Measure of walking speed without exoskeleton. Measure of mobility (specifically gait speed) while wearing exoskeleton. Scale 1 to 7 (1=total assistance and 7=independent)
Time frame: 18 weeks
Functional Independence Measures (FIM) gait score without exoskeleton
Measure of assistance required for walking without exoskeleton Scale 0 to 7 (0= activity does not occur and 7= complete independence
Time frame: 18 weeks
Walking Index for Spinal Cord Injury II (WISCI-II) score without exoskeleton
Measure of assistance required for walking without exoskeleton. Scale 0 to 20 (0= unable to participate and 20 Ambulates with no devices, no braces and no physical assistance.
Time frame: 18 weeks