Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05118971 |
| Other study ID # |
FUHSPortoAlegrePriscila |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Federal University of Health Science of Porto Alegre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Spinal cord injury is caused by any harmful process in the spinal cord, impairing its
function, generating loss of muscle strength, impairing orthostatism and walking. In
rehabilitation, some strategies are used to activate the muscles involved in the gait of
these individuals, including the ergometric bicycle and the elliptical. Understanding the
pattern of muscle activation generated by these methods is important to answer questions
arising from clinical practice. Thus, we seek to verify the pattern of muscle activation of
the vastus laterals, vastus medialis, gluteus medius, tibialis previous, rectus abdominis and
paravertebral muscles during exercises with ellipticals and ergometric bicycle with and
without electromyography biofeedback in individuals with spinal cord injury. Cross-sectional
study of the type crossover. Individuals will sign the Informed Consent Form (FICF) and
answer the identification form. They will be evaluated for functionality using the Functional
Independence Measure (FIM), injury classification by the American Spinal Injury Association
(ASIA) and muscle tone by the modified Ashworth scale. Later, they will be randomized to
define the order of the devices in which they will be evaluated. Muscle activity will be
verified with electromyography of the paravertebral, abdominal, vastus laterals, vastus
medialis, gluteus medius and tibialis anterior unilateral muscles on the right side of
individuals, comparing muscle activation during exercise cycling, elliptical and adding
biofeedback in both modalities. The wash-out interval between each evaluation will be 7 days.
We hypothesize that the elliptical with biofeedback will cause greater activation of the
assessed muscles.
Description:
Spinal cord injury is caused by any mechanism of injury that attacks and impairs the
integrity of the spinal cord, preventing it from performing its functions.
It is estimated that the incidence of spinal cord trauma in Brazil is greater than 10,000 new
cases per year, 80% being men and 60% aged between 10 and 30 years, with trauma being the
predominant cause.
Initial trauma causes injuries by mechanical force, which can cause damage by compression,
laceration or section. Any damage to this structure triggers an inflammatory response with
edema and, consequently, ischemia, gradually aggravating the injury process, compromising
neuronal homeostasis.
The ASIA scale is globally standardized to assess the type of injury. With this scale it is
possible to assess the sensory levels preserved through the corresponding dermatomes at each
level, testing the superficial and deep sensitivity below the level of the lesion. Motor
level is assessed by myotomes, grading the strength of each muscle corresponding to spinal
levels.
Neurological disorders resulting from spinal cord injury compromise motor, sensory and
autonomic functions, resulting in total or partial loss of voluntary muscle activity,
sensitivity, functioning of the urinary, intestinal, respiratory, circulatory and
reproductive systems. At the corresponding level, epicritic sensitivity is preserved as it
courses in the ipsilateral posterior funiculus. There will also be loss of painful and
thermal sensations due to disruption of the nerve fibers that cross the white commissure.
Muscle weakness is the most limiting impairment caused by neurological damage. There is a
limitation of activity and several restrictions, which influence the quality of life. The
deficit in muscle strength leads to limitations in performing a series of functional
activities. The strength of major muscles or muscle groups contributes to functional
capacity. Functional independence is positively associated with the peak torque performed by
the muscles used to perform a given task.
Physiotherapy has an essential role in the acute and chronic care of these patients, acting
as a guide, promoting a greater level of independence, and should aim at preventing
deformities, modulating muscle tone, enhancing respiratory muscle function, using various
techniques such as transfer training, postural changes, wheelchair handling, balance
training, orthostatism and, within the patient's functional potential, restoration of gait
and lower limb function, benefiting the performance of activities of daily living, and
quality of life.
In spinal cord injury, the deficit of muscle activation compromises many functional actions
such as the development of gait, but there are encouraging results with physical therapy
techniques that are effective in improving the prognosis of locomotor movement.
Therefore, a set of factors influence gait, which results from an interaction and
organization of the neural and mechanical systems, in addition to musculoskeletal dynamics,
modulation of the upper nervous system and the afferent pathway, which is also controlled by
the Central Pattern Generator through a programming based on a predetermined spinal circuit,
capable of producing a rhythm associated with gait.
The Central Pattern Generator is a network of neurons that can produce a variety of movement
activity, responsible for automating gait, which depends on feedback from proprioceptors and
higher nerve interactions. This generator is responsible for rhythmic motor patterns,
generated by inhibitory and excitatory processes of the lower limbs during movements. There
is an excitatory and inhibitory relay between agonist and antagonist muscles alternating
between limbs.
In these patients, this neuronal domain is compromised, making it difficult to modulate
muscle activation. However, recent studies have suggested the existence of effective
responses in locomotor training with partial body weight support, leading to an improvement
in locomotor patterns.
Locomotor training with partial weight bearing for neurological patients has been studied and
considered an important therapeutic mechanism in order to reduce the effects caused by
changes in spinal cord injury, being able to fully explore the activation of the patient's
potential inducing neural plasticity, providing motor related relearning to the specific
task.
Locomotor exercises are based on standardized neural activity. Process by which the central
nervous system develops its structure and function in human growth. Continuous repetition of
movement can help create this neural pattern in the brain and spinal cord.
There are some devices used in the physiotherapy routine that work rhythmically, for
locomotor training and activation of several muscles recruited in the performance of these
motor tasks, including the elliptical and the bicycle.
The elliptical is a walking simulator and can also be used for this purpose, which is
advantageous in this modality as it reduces the impact on joints, benefiting individuals with
impaired balance, as the feet remain in continuous contact with the support surface.
The elliptical provides training with cyclic movement, alternating the lower limbs through a
system of levers and sliding axles. When compared to walking on a treadmill, studies suggest
that the elliptical reduces plantar pressure in the contact phase of the heel, in addition to
reducing the impact of the foot with the contact surface, increasing muscle involvement and
increasing the contact phase. individuals with balance deficits.
During the use of the elliptical, the trunk, hip and knee maintain a greater degree of
flexion, indicating greater muscle activation of the glutes and vastus lateralis, compared to
walking on the ground.
In addition to the elliptical, the static bicycle, used in routine motor rehabilitation, can
also be a means of training and muscle recruitment. There is movement of the knees during
pedaling, the extension being the most impactful, since knee flexion is passive, as there is
no greater activation of the flexors.
The pedaling variation is composed of two phases, the ascending, when the pedals move from
the bottom to the top, and the descent, where the pedal displacement occurs from the top to
the bottom, with greater power.
Cycling exercise can be used for muscle activation and strengthening, also performed
rhythmically and alternately between the pedals. In the descending phase, there is activation
of the muscles: gluteus maximus, gluteus medius, vastus intermedius, vastus lateralis, vastus
medialis, rectus femoris, gastrocnemius and soleus, with hip and knee extension. In the
so-called ascending phase, the ilipsoas, hamstrings and tibialis anterior muscles are
activated with consequent flexion of the hip and knee.
Electromyography is a representation of the motor control of the muscular system through the
placement of electrodes in the motor units and capture of electrical activity. The
electromyographic analysis is used not only to verify muscle activity, but also to determine
the periods of coactivation of agonist and antagonist muscles, and can assess activity for
function, contraction and learning.
The electromyography signal originates from the electrical activity of the endplate. Thus,
the electromyographic signal is generated by the union of the activation potentials of the
motor units that are recruited concomitantly, resulting in the interference tracing.
Electromyographic biofeedback is an electronic instrument that provides information
(feedback) to an individual about a physiological function or response.
