Study design
The study was designed as a quasi-experiment by using the two-group pre-test, post-test design between June 2017 and November 2018. The study was approved by the official Ethical Committee at the Faulty of Physical Therapy, Cairo University (No: P.T.REC/012/00916) and followed the Guidelines of the Declaration of Helsinki on the conduct of human research.
Participants and randomization
Twenty male participants with traumatic motor-incomplete SCI of different ages were selected. The participants were referred from a neurologist with a diagnosis of traumatic incomplete spinal cord lesion. The participants were assigned randomly into two groups (A and B). Each group consists of ten patients. Randomization was performed by a blinded and an independent research assistant using computer-generated randomization cards saved in sealed envelopes. All subjects in both groups read and signed a written informed consent according to the guidelines established. Group A received a program of stepping on a treadmill with body-weight support (BWS) equal to 30% and Group B received a program of stepping on a treadmill with BWS of 40%.
This study was conducted on the patients with persistent spinal cord trauma of not less than 1 year preceding the beginning of their participation with an age range from 18 to 40 years. The participants had spinal cord damage at T9–T12 with an AIS (American Spinal Injury Association score) of B (preservation of sensory function not motor function below the neurologic level), C (preservation of motor function below the neurologic level and more than half the key muscles below the neurologic level have less than grade fair) or D (motor function is preserved below the neurologic level and more than half of the key muscles below the neurologic level have a muscle grade of fair or more strength). All the patients had the capacity to make no less than one stride with one leg and to rise up from sitting to remaining with, at most, moderate help (half exertion) of one other individual and consented to keep up the present daily schedule of drugs and activity levels while training.
All the patients included in the both groups were subjected to a full detailed history and a full clinical examination for exclusion of the following: patients with an AIS score of A which indicates complete SCI, significant cardio-respiratory/metabolic disorder or other neurologic or orthopedic damage that may restrain exercise participation or weaken the locomotion. The patients with history of peripheral neuropathy, neoplasia, degenerative myelopathy and congenital spinal cord anomalies or those with a history of botulinum toxin treatment to the lower limbs < 6 months before enrollment or size confinements for the harness/counterweight system were also excluded from the study.
Assessment procedures
All the patients in the both groups underwent these testing procedures prior to and following the training while allowing the patients to self-select their preferred speed of walking. These are the most accurate reflection of individuals’ actual everyday performance. All patients performed a test battery containing a long-bout (2-min) walking test and a short-bout (6 m) walking test. These two tests were performed within the same week. The BWS used for each group of patients was extracted using a ground reaction force equation from force platform (load-cells) for continual measurement of BWS and regulation of the amount of weight exerted on the patient’s legs.
Outcome measures
These following outcome parameters were assessed using the force platform or video camera optional after ending of the training sessions including walking speed, step length, stride length, cadence, and step width.
General training methods
All the subjects in both groups were educated about the training methods before starting the sessions. The locomotor training gave tactile prompts and phasic data related to ambulation. These prompts are basic to initiate stepping in humans after a SCI:
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1)
Stepping speeds roughly of typical walking speeds (0.75–1.25 m/s)
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Maximum reasonable load on stance limb
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3)
Upright with extended trunk and head. Approximation of normal hip, knee, and ankle kinematics for walking
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4)
Synchronize the incidence of the hip extension and unload of the limb with synchronous loading of the contralateral limb
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5)
Avoid upper limb weight-bearing and encourage reciprocal arm swing
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6)
Facilitate symmetrical interlimb coordination
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Reduced sensory stimulation may strife with tactile data correlated to ambulation [2].
The subjects in both groups were allocated an hour of rehabilitation for each exercising day, with installation and bring down occupying a normal of 10 to 15 min of this designated duration. The patients were expected to manage 2 days per week for about a 1.5 months [4] .
Subjects were permitted to utilize the handrails for equilibrium as required. All patients appointed to the treadmill-based rehabilitation clusters were asked to walk at their greatest conceivable velocity.
Treatment methods
Toward the beginning of every set, velocity was increased to medium at which the stepping level started to debase. At that point, speed was decreased to the medium at which the step level is satisfactory and the patient was permitted to walk at this velocity. Following 1 to 2 min at this velocity, the patient was tested through increasing the treadmill velocity increments by 0.32 km/h (0.2 miles/h). When the patient had finished ten paces at this maximum velocity, the velocity was returned to the earlier medium level. When the patient recuperated from the quicker session, the velocity again was increased until the patient could finish 20 paces at the quicker velocity. This arrangement proceeded until the patient was comfortable with the recent increase to a greater velocity. The velocity was increased as such until the point that a speed was reached at which other increments were related with a debasement of pace level.
Group A (step training on a treadmill with BWS rise to 30%):
Patients in the treadmill cluster were given help with pacing depend on the rules prescribed by Behrman and Harkema [6]. Actually, that a subject could not freely adjust or keep up their complete weight of body support during stepping and achieving proper leg kinematics, a weight of body load (BWS = 30%) was utilized with an end goal to give a protected and viable condition for ambulation. A medical harness worn by the patient and associated with an overhead-motorized load over the treadmill supplied the support. The quality of the weight load was acclimatized to expand dual leg support with no knee clasping in the stance. On the off-chance that the patient, during step rehabilitation with our modality, might not produce the proper leg and torso kinematics related to ambulation, hand help was given. Flexible lateral backings connected corner to corner to the patient and to the lateral bars for equilibrium were vital but still permitted upper limb swing. Each patient was urged to swing their upper limb equally with their legs [5].
To start ambulating on the treadmill, the patients remain with their legs in a site reenacting a stride, with one leg in extension close to the mid-stance phase of the step cycle and loading most weight. As the velocity of the treadmill increments plus conveys the leg behind to a place of final stance, the patient moves their weight along the side and in front to the contralateral lower limb because it achieved the first contact. Along these lines, the weight will be expected to rapidly exchange to the front leg, and the behind leg can then start to swing [6] .
Position of the leg on the treadmill was observed and helped if important. Proper imitation of foot motion via all phases of walking was cardinal in eliciting stepping on the treadmill. An ideal stepping design is to be accomplished when it is spatially and temporally planned and most resemble normal walking. The duration of step training sessions was controlled by (1) patient asthenia, (2) joint kinematics support lined up with ambulation, and (3) appropriate weight shift and leg supporting patterns through the feet.
Group B (step training on a treadmill with BWS squares of 40%):
the same procedures were used with Group A of participants were of Group B with the difference that the (BWS = 40%).
Statistical analysis
Information was investigated utilizing IBM Statistical Package for the Social Sciences (SPSS) Advanced Statistics version 22.0 (SPSS Inc., Chicago, IL, USA). All values are displayed as mean ± standard deviation (SD). All evaluation factors were examined for normality of distribution (Shapiro-Wilks test). An independent t test was utilized to contrast the measure of variations in the BWSTT 30% and BWSTT 40% groups following 1.5 months. A p value of less than 0.05 was considered significant [7].