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more effective than a later start. In spite of methodo-
logical differences, there seems to be consensus that
early gait training in motor incomplete SCI improves
over-ground walking independently of the training
method (15). This also seems to hold true for patients
with chronic incomplete SCI (> 1 year post-injury) (7).
Uncertainty exists, however, as to whether patients
with incomplete SCI with more severe functional deficit
also benefit from such training, because patients without
walking function before training are frequently unable
to walk independently after intervention (5, 6, 13).
The aim of the present study was to evaluate the
effects on physical function of BWSLT with manual
assistance compared with usual care, in subjects with
chronic incomplete SCI (2+ years post-injury) and
severely reduced or no gait function, classified by the
American Spinal Injury Association (ASIA) Impair-
ment Scale (AIS) as grade C–D (16).
METHODS
A single-blinded RCT was conducted in collaboration with the
3 Norwegian SCI rehabilitation units in order to investigate
the effect of BWSLT with manual assistance in subjects with
incomplete SCI who lived outside the Norwegian capital Oslo
(where another study was recruiting SCI subjects). Fig. 1 shows
patient flow through recruitment, assessment, intervention and
follow-up.
Training protocol
Subjects in the control group received usual care from their
local physical therapist. Physical therapy sessions varied in
frequency and, for some, included merely passive movement
of the joints in the lower extremities and stretching, whereas
more than 50% of subjects also had some sessions with over-
ground gait training and independent training in the gym. Their
daily activities and training were recorded in a diary that was
submitted monthly, and subjects received follow-up telephone
calls and were advised not to change their training programme/
leisure-time physical activities during the study.
A treadmill with body-weight support system (Vigor Equip-
ment, Inc., Stevensville, MI, USA) was used for 60 days train-
ing, with 2 daily sessions of BWSLT with manual assistance
for a total of 90 min per day, 5 days per week during 3 periods,
each of 4 weeks. The duration of each training session depended
on each subject’s endurance, ability to maintain correct move-
ments in the lower extremities and ability to maintain normal
walking rhythm. The aim was to reduce the body-weight sup-
port to < 40% and/or increase walking speed towards normal
(3–5 km/h). Lower-limb braces or orthoses were not allowed
during BWSLT, and there was minimal use of handrails for
support. A mirror placed in front of the subject provided visual
feedback during training. Each training session involved a team
of 3–5 persons to facilitate movements of the pelvis and legs.
Subjects received soft-tissue mobilization/stretching before and
after each session to prepare for training and reduce spasticity.
BWSLT also included over-ground training. The subjects were
given home exercises for use between the training periods,
selected to improve carry-over of learned skills from treadmill
www.medicaljournals.se/jrm
to the community environment. Data from each training session
were recorded in an Excel file.
Recruitment and consent
Subjects were recruited from the 3 SCI units in Norway through
advertisements in national magazines for persons with SCI.
The Regional Committee of Ethics (REK) in North Norway
approved the study (P REK NORD 69/2008) (ClinicalTrials.
gov identifier #NCT00854555). All potential study subjects
gave their written informed consent before final evaluation
for inclusion. The inclusion criteria were age 18–70 years and
motor incomplete SCI classified as AIS C–D, with a minimum
of 2 years since injury. Subjects should primarily be wheelchair
dependent with or without some walking ability, have body mass
index (BMI) < 30, be cognitively unaffected and motivated for
locomotor training. Exclusion criteria included spasticity and
contractures that inhibited locomotor training, known osteo-
porosis in the lower limbs, pregnancy, participation in other
intensive training programmes, medical conditions that might
interfere with the training protocol, and previous knee or hip
replacement. Subjects were encouraged not to change their
anti-spasticity medication during the study period.
Setting
Assessments before and after the intervention or control period
were conducted single blindly at Sunnaas Rehabilitation Hos-
pital outside Oslo. The in-patient intervention site was North-
Norway Rehabilitation Center, Tromsø.
Randomization was concealed. Allocation to intervention (I)
or control (C) groups was performed by the sealed envelope
method, in blocks of 10. The project coordinator prepared the
sealed envelopes and a staff member, who was not involved with
the study, selected an envelope for each subject and informed
the project coordinator on the allocation.
Outcome measures
Evaluation and testing were carried out prior to randomization,
within the last month before start of the intervention/control
period. Post-evaluation took place 2–4 weeks after the final
intervention/control week. The assessors (physicians and phy-
sical therapists) were blinded to each subject’s group allocation.
All primary outcome measures used are common in neurolo-
gical and SCI rehabilitation: (i) change in over-ground walking
speed; (ii) distance walked with use of necessary walking aids;
and (iii) lower extremity motor score (LEMS), a subscale in
the ASIA classification that assesses muscle strength. The
score range is 0–5 for each of 5 key muscles (hip flexors, knee
extensors, ankle dorsi-flexors, long toe extensors and ankle
plantar flexors) of each leg, with maximum score of 50 (16).
Walking speed was assessed with the 10-m walk test (10MWT),
where subjects are asked to walk 10 m as fast as possible with
a flying start (17). The mean time of 2 tests was recorded. En-
durance was measured by the 6-min walk test (6MWT), where
the distance walked within 6 min is measured (17).
Secondary outcomes were change in balance and aerobic
capacity. Berg’s balance scale (BBS) was used for dynamic
balance test, and the Modified Functional Reach test (MFR)
for postural control. The quality of performance on each of
the 14 tests is recorded using a 4-point scale (maximum score
56 points) (18, 19). Higher scores indicate better balance. The
MFR assesses postural control in the sitting position in subjects