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Table I. Baseline demographics of study subjects according to
intervention or control group
Variables
Sex, n (% males)
Age, years, mean (SD)
Post-injury time in years, median (range)*
Traumatic injury, n (%)
Injury level, n (%)
Cervical
Thoracic
Lumbar
ASIA classification, n (%)
AIS C
AIS D
Marital status, n (%)
Married
Other
Smoker, n (%)
Education, n (%)
< 7 years
Elementary school
High school
University
At work, yes, n (%)
Use of antispasmodics, n (%)
BMI (kg/cm 2 ), mean (SD)
Ambulation ability, n (%)
Wheelchair dependent
Wheelchair independent
Combined user
Use of assistance/day, n (%)
None
> 2 h
3–5 h
> 6 h
Intervention Control group
group ( n =10) ( n =10) Characteristics Mean (SD) 6 (60)
46 (14)
5 (2–33)
4 (40) 9 (90)
54 (13)
3 (2–22)
6 (60) Number of days a Days from 1 st to last training session 56 (4) 50–60
154 (20) 137–189
3 (30)
4 (40)
3 (30) 5 (50)
4 (40)
1 (10) 3 (30)
7 (70) 3 (30)
7 (70) 3 (30)
7 (70)
1 (10) 4 (40)
6 (60)
1 (10) 1
0
6
3
5
6 0
2
4
4
2
2
(10)
(60)
(30)
(50)
(60)
25.7 (5.1)
(20)
(40)
(40)
(20)
(20)
25.2 (2.5)
5 (50)
3 (30)
2 (20) 2 (20)
2 (20)
6 (60)
6 (60)
3 (30)
0
1 (10) 8 (80)
1 (10)
1 (10)
0
BMI: body mass index; SD: standard deviation; ASIA: American Spinal Injury
Association; AIS: American Spinal Injury Association Impairment Scale.
Distance stepped per training day, m b
Effective stepping time on treadmill, min/day
c
Used bodyweight support, kg
Used stepping speed on treadmill, km/h
Used stepping speed on treadmill, m/s
1,202 (420)
36 (12)
Min–Max
741–1,746
21–54
24.4 (5.0)
2.0 (0.3)
0.6 (0.1)
9.1–30.6
1.4–2.3
0.4–0.6
a
Major public holidays prohibited completing 60 training sessions or participants
travel arrangements from the rehabilitation facility to home. b Total of 2 training
sessions up to 90 min on treadmill. c Mean kg of all training sessions through
stays 1 and 3. SD: standard deviation.
Table IV. Mean change in walking distance and walking speed on
the treadmill from first to last training session
Distance walked per training session, m
Speed, km/h
Mean diff (95% CI) p-value
301 (–43, 644)
0.9 (0.5, 1.3) 0.08
0.001
95% CI: 95% confidence interval.
The difference in mean changes between the groups was
2.7 (95% CI –1.4, 6.8, p = 0.19) (Table V).
As part of the statistical plan, a few a priori variables
were selected for possible adjustment in the final ana-
lyses. Because of the small numbers, the intervention
and control groups were imbalanced with respect to
baseline levels of some of these a priori selected va-
riables. Adjustment by multivariable linear regression
did not change the main results (Table SI 1 ).
Other outcomes
Table II. Outcome measures at baseline
Variables Intervention group
( n = 10) Mean (SD) Control group
( n = 10)
10MWT, m/s
6MWT, m
LEMS
BBS, mean (SD)
MFR, cm
VO 2max , l/min 0.5 (0.5) n = 8
226 (151) n = 7
26.9 (13.0)
32 (19)
40 (7)
1.4 (0.5) 0.5 (0.3) n = 8
165 (98) n = 7
28.3 (12.6)
29.3 (18.2)
42 (12)
1.5 (0.4) n = 8
Mean (SD)
SD: standard deviation; BMI: body mass index; LEMS: lower extremity motor
score; 6MWT: 6-min walk test; 10 MWT: 10-m walk test; WISCI: Walking Index
for Spinal Cord Injury; BBS: Berg’s Balance Scale; MFR: Modified Functional
Reach test; VO 2max : maximal oxygen uptake.
and there was no significant difference bet-
ween the groups (–4.3 m (95% CI –52.7,
44.1)) (Table V). One subject was unable
to walk due to pain in his lower limb, thus
we were only able to repeat the 6MWT in
6 subjects in the control group.
Baseline range in LEMS was similar in the
2 groups, 6 to 46 and 8 to 40 points in the
intervention and control groups, respectively.
In the intervention group, LEMS increased
by a mean of 2.1 points (SD 2.8, p = 0.05),
whereas there was little change in the control
group (mean change –0.6 (SD 5.1), p = 0.75).
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Table III. Body-weight supported locomotor training data from
the intervention group, n = 9
Changes in balance, as measured by BBS and MFR, are
shown in Table V. There was no significant difference
in change between the groups for either outcome, –1.2
points 95% CI (–4.3, 1.9), p = 0.42 and 6.6 cm (–5.4,
18.5), p = 0.26, respectively, for BBS and MFR (Table
V). There was no significant change in VO 2 measure-
ment in any group, nor in the difference between them
((0.0 l/min, 95% CI (–0.2, 0.3), p = 0.87)) (Table V).
However, for the VO 2 test there were small numbers
Table V. Changes in walking speed and walking distance, strength, balance,
aerobic capacity, from baseline to evaluation 2–4 weeks post-intervention/
control period
Intervention group
(n = 9)
Variables
10MWT
6MWT
LEMS
BBS
MFR, cm
Mean (SD)
0.2 (0.3) a
25.4 (40.9) a
2.1 (2.8)
0.0 (2.6)
0.8 (15.4)
VO 2max l min –1 –0.1 (0.2) a
a
Difference in
mean change
between the
p-value Mean (SD) p-value groups (95% CI)* p-value
0.14
0.15
0.05
1.00
0.88
0.37
Control group
(n = 9)
0.1 (0.2) a 0.23
29.6 (38.2) b
–0.6 (5.1)
1.2 (3.9)
–5.8 (6.9)
–0.1 (0.2) c
0.1 (–0.2, 0.4) 0.43
0.12
0.75
0.33
0.04 –4.3 (–52.7, 44.1)
2.7 (–1.4, 6.8)
–1.2 (–4.3, 1.9)
6.6 (–5.4, 18.5) 0.85
0.19
0.42
0.26
0.18 0.0 (–0.2, 0.3) 0.87
n = 7, b n = 6, c n = 8, *Change in intervention group – change in control group.
10MWT: 10-m walk test; 6MWT: 6-min walk test; LEMS: lower extremity motor score; BBS:
Berg’s Balance Scale; MFR: Modified Functional Reach test; VO 2max : maximal oxygen uptake;
SD: standard deviation; 95% CI; 95% confidence interval.