Table 3.
Baseline clinical and demographic data for all enrolled participants: (A) Ekso group baseline clinical characteristics, (B) Active Control group baseline clinical characteristics, and (C) Passive Control group baseline clinical characteristics.
Subject ID | Gender | Age (yrs) | Time since injury (yrs) | AIS | ISNCSCI (motor) (L-R) | ISNCSCI (sensory) (L-R) | WISCI-II | SCI-FAI | SCIM-III | LEMS | UEMS | SCATS (clonus) (L-R) | SCI-SET Total Score | Gait speed (SS, m/s) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(A) | ||||||||||||||
01-123a | F | 41 | 22.3 | C | T1-T2 | T2-C8 | 12 | 2 | 13 | 14 | 50 | 2-2 | 0.00 | 0.18 |
02-108a,b | M | 26 | 7.8 | C | L1 | T10-L4 | 12 | 3 | 17 | 19 | 50 | 0-0 | −0.11 | 0.34 |
02-115a,b,c | F | 38 | 2.1 | C | T11 | T11 | 19 | 5 | 33 | 23 | 50 | 0-2 | −1.00 | 0.41 |
02-1271 | M | 48 | 8.0 | D | C3-C6 | C3-C4 | 16 | 4 | 21 | 37 | 37 | 2-2 | −1.20 | 0.22 |
02-130a,b | M | 48 | 28.5 | D | C6-T1 | C7-C4 | 19 | 5 | 33 | 40 | 47 | 1-1 | −0.63 | 0.43 |
02-132 | M | 37 | 2.3 | D | C6-C7 | C6-T8 | 6 | 1 | 7 | 28 | 38 | 1-1 | −0.29 | 0.38 |
04-1061 | F | 35 | 9.3 | C | T1 | T1 | 9 | 3 | 17 | 20 | 50 | 1-1 | −0.50 | 0.16 |
07-1081 | M | 58 | 7.2 | D | C5-C7 | C5-T10 | 13 | 3 | 16 | 22 | 28 | 1-1 | 0.00 | 0.34 |
07-110a,b,c | F | 48 | 1.2 | D | T1-C7 | C4 | 12 | 4 | 30 | 45 | 48 | 1-0 | −1.42 | 0.26 |
08-105a,b,d | F | 46 | 8.1 | C | C7 | T2 | 13 | 3 | 20 | 26 | 32 | 1-1 | −0.53 | 0.42 |
09-106 | M | 34 | 1.6 | C | T7-T6 | T7-T6 | 6 | 1 | 17 | 17 | 50 | 1-1 | −0.35 | 0.09 |
09-108 | M | 41 | 2.4 | D | C5-C3 | C5-C3 | 8 | 2 | 6 | 36 | 32 | 2-2 | −1.60 | – |
(B) | ||||||||||||||
01-115a,d | F | 61 | – | C | L1–T10 | L1-T10 | 16 | 4 | 19 | 7 | 50 | 0-0 | −0.49 | 0.24 |
02-109a,d | F | 28 | 2.8 | D | T5-T7 | T5-T7 | 19 | 4 | 31 | 42 | 50 | 0-0 | −0.29 | 0.30 |
02-114a | F | 34 | 10.4 | C | L1 | C6-L1 | 6 | 2 | 17 | 11 | 50 | 0-0 | −2.63 | 0.09 |
02-118a | M | 56 | 10.5 | D | T1 | C7-C6 | 19 | 4 | 25 | 24 | 50 | 1-1 | −0.31 | 0.35 |
02-125a | M | 56 | 8.8 | C | C7–C6 | C7-C6 | 13 | 2 | 5 | 23 | 28 | 0-0 | −0.26 | 0.16 |
04-103a | M | 65 | 2.3 | D | T1 | C8-T1 | 13 | 4 | 21 | 38 | 50 | 1-1 | −0.12 | 0.30 |
04-104a | M | 52 | 12.3 | D | C3 | C3 | 18 | 4 | 23 | 33 | 36 | 1-1 | −0.41 | 0.26 |
07-107a | F | 62 | 4.2 | D | C1 | C1 | 6 | 2 | 12 | 50 | 48 | 1-1 | −2.47 | 0.16 |
08-103a | M | 31 | 6.2 | D | C1 | C4-C8 | 13 | 4 | 19 | 39 | 50 | 0-0 | −0.09 | 0.17 |
08-106 | F | 64 | 14.2 | D | T12-L2 | T12-L1 | 16 | 5 | 29 | 44 | 50 | 0-0 | −0.22 | 0.48 |
09-104 | F | 43 | 3.6 | D | C5 | C4 | 13 | 1 | 4 | 36 | 14 | 2–2 | −1.12 | 0.03 |
09-105a,c | M | 71 | 2.1 | D | C5 | T7-T4 | 13 | 5 | 20 | 47 | 40 | 0-0 | −0.44 | 0.35 |
(C) | ||||||||||||||
01-116a | M | 74 | 1.7 | D | C7 | L4-L3 | 9 | 3 | 22 | 45 | 46 | 1-0 | −0.14 | 0.17 |
02-112a | M | 59 | 10.0 | D | C7 | C5 | 16 | 5 | 30 | 41 | 36 | 0-1 | −0.94 | 0.34 |
02-129a | M | 45 | 11.0 | D | C3-C2 | C3-C2 | 6 | 3 | 19 | 18 | 50 | 0-0 | −0.56 | 013 |
07-105a | F | 59 | 1.3 | D | C3-C7 | C3-T1 | 13 | 3 | 16 | 43 | 44 | 0-0 | −0.09 | 0.33 |
08-104a | M | 26 | 1.2 | D | T4 | T5-T4 | 13 | 2 | 19 | 35 | 50 | 1-1 | −0.12 | 0.12 |
09-107a | M | 31 | 1.0 | D | C6–C7 | T9 | 13 | 3 | 17 | 33 | 34 | 1-1 | −0.23 | 0.24 |
Baseline clinical and demographic data for all enrolled participants in (A) Ekso, (B) Active Control and (C) Passive Control groups. Baseline characteristics were comparable across all treatment groups.
AIS ASIA Impairment Scale, ASIA (American Spinal Injury Association), ISNCSCI International Standard for Neurological Classification of Spinal Cord Injury, WISCI-II Walking Index for Spinal Cord Injury, SCI-FAI Spinal Cord Injury Functional Ambulation Index, SCIM-III Spinal Cord Independence Measure, LEMS Lower Extremity Motor Score, UEMS Upper Extremity Motor Score, SCATS Spinal Cord Assessment Tool for Spastic Reflexes, SCI-SET Spinal Cord Injury Spasticity Evaluation Tool, SS self-selected.
aPer Protocol Group.
bResponder to > 0.44 m/s threshold.
cResponder to MCID threshold.
dResponder to both thresholds.