Body-weight supported locomotor training in incomplete SCI
without independent standing ability (20). Aerobic
capacity was tested on an arm crank ergometer (Lode
Angio, Groningen, the Netherlands) and breath-by-
breath spirometer (Vmax 220 Sensormedics Corp.,
USA): stepwise, graded exercise until exhaustion.
Maximal oxygen uptake (VO 2max ) (l/min) was recor-
ded by a computerized standard open-circuit techni-
que breath-by-breath spirometer.
115
Prescreening through the patients registries (n= 115). Invitation to join the
study (n=70). 37 subjects returned written informed consent form.
Enrollment
Assessed for eligibility (n= 29)
Excluded (n=9)
Not meeting inclusion criteria (n=9)
Declined to participate (n=0 )
Randomized (n=20)
Statistical analysis
Sample size. It was estimated that 30 subjects (15
subjects in each group) were required to obtain a
Allocation
statistical power of 0.80 with alpha error 0.05 for
Allocated to intervention BWSLT with
Allocated to control (n=10)
primary outcomes. The calculations were based on
manual assistance (n= 10)
the expected differences between intervention and
Follow-Up
control groups obtained from primarily our own
Drop-out (n=1)
Drop-out (n=1)
pilot study (unpublished) and, to a lesser degree, on
Due to personal reasons
Due to personal reasons
published literature (15, 21). The expected training
improvements, e.g. differences in change between
Analysis
the intervention and control groups, were 0.5 m/s
Analysed (n=9)
Analysed (n=9)
(SD 0.6) in 10MWT, 55 m (SD 40) in 6MWT, and
4 wheelchair dependent subjects*
2 wheelchair dependent subjects
15 points (SD 7) in BBS.
5 wheelchair independent or combine users
7 wheelchair independent or combine users
The main analysis compared mean or median
*Two of these were able to stand and take 1 step and thus
changes from baseline to final evaluation. Comparison
participated in the walking tests.
of baseline values between the 2 groups was done
Fig. 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram of
using χ 2 test/Fisher exact test for categorical vari-
participants.
ables and independent samples t-test (2-tailed test
with significance level p < 0.05). For non-normally
distributed data, the Mann–Whitney test was used.
Two subjects, one from each group, dropped out for
Paired samples t-test or Wilcoxon signed-rank test was used to
personal reasons after 1 and 18 weeks, respectively.
analyse change within groups. The difference in change between
Thus, 9 subjects from each group were available for
the 2 groups was assessed using linear regression. The data was
post-analyses.
analysed with the 23 rd version of SPSS for Windows (IBM SPSS,
The training intervention was well tolerated with no
Armonk, NY, USA). Because of low numbers, the intervention
and control groups were imbalanced on several parameters at
adverse events, and there were only minor side-effects,
baseline. Therefore, multivariable analyses adjusting for a priori
such as superficial abrasions, which did not interfere
selected variables potentially related to treatment effect were
with the regular training programme. Baseline data
1
also carried out (Table SI ).
RESULTS
As shown in Fig. 1, only 20 of the planned 30 study
subjects were recruited within a reasonable timeframe.
Based on search of the medical records from the 3 SCI
units in Norway, 115 potential participants were iden-
tified based on injury type, time of injury, functional
level and age. In addition, some subjects contacted
project workers directly as a result of information they
had obtained from advertisement campaigns. These
subjects were pre-screened for eligibility through a
phone call. A total of 70 subjects who met the inclusion
criteria, were invited to join the study and, of these, 37
returned the written consent form. Eight of the 37 did
not attend the clinical pre-screening, leaving 29 subjects
who completed the full screening procedure at Sunnaas
Hospital. However, nine subjects did not meet the in-
clusion criteria and thus 20 subjects were randomized
http://www.medicaljournals.se/jrm/content/?doi=10.2340/16501977-2508
1
on the study subjects are shown in Table I. Some dif-
ferences and potential imbalances in baseline levels
of outcome variables are seen between the groups in
strength, distance covered, walking speed, balance
and aerobic capacity (Table II). Detailed BWSLT data
were recorded daily for each person in the intervention
group, and are summarized in Tables III and IV.
In each group, 2 subjects with AIS grade C (22%) were
unable to walk at baseline, and did not gain independent
walking post-intervention. Thus, only 7 subjects in each
group, those with some ambulatory function at baseline,
were available for post-intervention testing of walking
speed (10MWT) and distance covered (6MWT). Fig. S1 1
shows individual changes in walking speed (10MWT)
and distance covered (6MWT) in each group.
Both groups walked faster (10MWT) at post-test.
However, the difference between the 2 groups was
small (0.1 m/s (95% CI –0.2, 0.4)), and not statistically
significant.
Endurance (distance walked), as measured by the
6MWT, improved approximately the same amount in
both groups; the standard deviations were very large
J Rehabil Med 51, 2019