Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04686630 |
Other study ID # |
20173034004 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2019 |
Est. completion date |
February 15, 2020 |
Study information
Verified date |
December 2020 |
Source |
Yeditepe University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Children with Cerebral Palsy have generally limited selective motor control which affects
their ability to complete functional tasks Selective Motor Control has been shown to
correlate with specific characteristics of gait, however in video based observational gait
analysis, the sub phases of the gait cycle, which are affected by selective motor control,
has not been investigated in children with Cerebral Palsy. Therefore the aim of this study
was determine the relationship between Edinburgh Visual Gait Score and Selective Motor
Control of the Lower Extremity test in children with cerebral palsy. Forty-two cerebral palsy
children with Gross Motor Function Classification System level I-II-III and between 4-18 ages
were participated for the study. After the demographic characteristics and all assessments of
the patients were recorded, the gait characteristics of children were assessed by video based
observational gait analysis. According to Edinburgh Visual Gait Score, phases of gait were
analyzed.
Keywords: Cerebral Palsy, Selective Motor Control, Gait, Edinburgh Visual Gait Score
Description:
Introduction and Purpose
Cerebral palsy (CP) is a group of permanent but non-progressive neurological disorder that
emerges before, during, and after the birth. That disorder causes problems in the development
of movement and posture and activity limitations. Motor disorders seen in CP are frequently
accompanied by sensory and perception disorders, cognitive, communication and behavioral
problems. In addition, epilepsy and secondary musculoskeletal problems are also added to this
issue. CP varies according to etiology, severity and location of the disorder.
It is a form of classification defined by the Surveillance of Cerebral Palsy in Europe
(SCPE). This classification method according to the clinical features of children with CP;
Spastic type CP, Dyskinetic type CP, Ataxic CP and Unclassified / Other ".
In spastic CP, neurological damage to the corticospinal tract (CST) results in four
interconnected neuromuscular deficiencies are shortened muscle-tendon unit, muscle weakness,
spasticity and impaired selective motor control (SMC). These deficits are caused by brain
damage, which disconnects with descending inhibitory and excitatory signals and consecutive
changes in the motor unit, muscle fiber composition and muscle growth . These causes lead to
inadequate motor functions in children with CP. More involvement of sensory-motor areas may
impair motor function and proprioception. As well as, these neuromuscular deficits lead to
the gait disorders which have commonly seen in children with spastic CP.
Although most of the studies have focused on spasticity and muscle weakness, recent research
reveals the importance of SMC. SMC is described as the ability to isolate muscle activation
in a selected pattern when a voluntary movement or posture is required.SMC skills are
responsible for the movement and control of joints in agile and independent manner.
The etiology of SMC loss has not been entirely understood, but it is known that voluntary
movements are provided by corticospinal ways. The corticospinal pathways undertake the task
of determining the direction of movement and controlling force production for movement. The
corticospinal pathways are located in the periventricular white matter (PWM). PWM injury is
the most common finding in magnetic resonance imaging (MRI) of children with spastic type CP
.CST are located in the PWM. Therefore, especially in children with spastic type CP, SMC
failure or loss is quite common.
SMC skills of the upper extremities are considered as a basic factor for the realization of
many activities such as eating, participating in daily living activities, performing
self-care activities and writing. In addition, SMC can be used as an important guide in
clinical interventions such as botulinum toxin treatment and selective dorsal rhizotomy. For
these reasons, a detailed evaluation of the SMC is of great importance. However, it is
noteworthy that studies on the evaluation of SMC are insufficient. The Selective Control
Assessment of the Lower Extremity (SCALE) test, as the first scale that evaluates the lower
extremity in a comprehensive manner and with the high level of evidence. The SCALE test which
was developed as a clinical tool for evaluating SMC in lower extremities in children with CP,
stands out compared to other selective motor control tests .It has has a high level of
validity and reliability. The first instrument designed specifically to evaluate SMC ability
of the upper extremity is the "Selective Control of Upper Extremity Scale (SCUES). Both
measuring instruments are very useful, practical and understandable.
Recent studies have been focused on the idea that SMC will guide the treatment of
physiotherapy and rehabilitation. Additionally, botulinum toxin can be used as a guide in
surgical procedures. Beside the influence of weakness, short muscle-tendon unit, and
spasticity in gait has been studied, the impact of impaired SMC on overall gait pattern has
not been investigated.
SMC problems in children with CP affects motor activities at functional level such as
crawling and walking. When SMC decreases or disappears, the synergy that occurs in the lower
extremity prevents the performance of gait cycle or deteriorates the quality of gait. In the
literature, the effect of SMC on gait cycle investigated with 3DGA; however, impaired SMC on
the sub-phases of the gait cycle was not well defined in VBOGA.
In the literature, the effects of SMC on gait were investigated by three-dimensional gait
analysis (3DGA); however, 3DGA is not widely used in every clinic and requires the expensive
and complicated equipment. This makes the basis for us to conduct this study.
The Edinburgh visual gait score (EVGS) was developed for gait assessment using video
recordings in children with CP. Additionally, in video based observational gait analysis, the
sub-phases of the gait cycle, which are affected by SMC, has not been investigated in
children with CP. Therefore, the aim of this study was to determine the relationship between
EVGS and selective motor control of the lower extremity in children with CP.
Material and Method This study was conducted between July 2019 and December 2019 in the Human
Motion Assessment Laboratory in Istanbul to investigate the relationship between the SMC of
children with CP and the Edinburgh Visual Gait Score.
The study was approved by the Medical, Surgical and Drug Research Ethics Committee of
Yeditepe University Faculty of Medicine and conducted in accordance with the Declaration of
Helsinki.
3.1. Participants
Prior to the study, the families and children of all children with spastic CP were informed
about the purpose of the study, all the assessments to be applied during the study and the
benefits of the study; families and children who volunteered to participate in the study were
signed an informed consent form that they voluntarily participated in the study.
The children with CP and their families were evaluated in terms of eligibility for the study.
However, children who did not meet the inclusion criteria were excluded from the study and a
total of 42 children were included in the study. Both SCALE and EVGS assessment scales were
applied to the 42 children included in the study. Twenty-four spastic diparesis and eighteen
spastic hemiparesis cases were included in the study. Data was collected from 84 lower
extremities. There were 22 female and 20 male patients aged between 4-18 years.
Criteria for inclusion in the study:
- Children with a diagnosis of diplegic or hemiparetic CP.
- Between 4-18 years old,
- GMFCS level I-II-III,
- Can understand simple verbal commands,
- The study was conducted in children of families who accepted the study.
Criteria for exclusion from the study:
- Children who do not meet the criteria for inclusion,
- Children with ataxic and dyskinetic type CP were identified.
- Children who exhibit discordant attitudes during the assessment (crying, indignation),
- Families and children who want to quit working anywhere in the study,
- Children who could not complete the assessment were identified as.
3.2. Methods This study was planned to investigate the relationship between SMC and walking
of children with CP. Personal and disease-related information of 42 individuals with diplegic
or hemiparetic CP were recorded by using the data collection form. Information collection
form; The patient's name-surname, age, gender, height, weight, history, gestational age,
birth weight, SCALE Test, GMFCS, Modified Ashworth Scale (MAS), Range of Motion (ROM), EVGS,
affected side and previous surgical histories were recorded and their functional levels were
determined and recorded. The evaluations used in this context are indicated below.
Assessment Methods Selective Control Assessment of the Lower Extremity (SCALE)
The SCALE test was developed by Fowler et al. (10) to evaluate SMC of the lower extremity. It
is a valid and reliable assessment method that does not require any special equipment during
application. Application time is approximately 10 minutes. In addition, motion of ankle joint
(S1), motion of subtalar joint (S2), motion of toes joint (S3), motion of knee joint (S4) and
motion of hip joint (S5) parameters of the SCALE test were evaluated separately and
bilaterally five. All evaluations are performed in the sitting position except for the hip
joint. When evaluating the hip joint, the participant is in the lying position with the
tested hip facing up. During the evaluation, clothing that prevents the observation of the
extremities of the evaluated person is more easily removed. Joints of motion can be observed
and scored more easily by using a short.
The evaluation positions for each S1, S2, S3, S4 and S5 are specified separately. The patient
is asked to perform the desired movement for each joint level in approximately 3 seconds and
with a specific oral tempo. The degree of SMC is determined as "normal" (2 points) if the
patient could move the tested joint isolated, within at least 50% of the possible range of
motion and at a physiological cadence cued orally by the therapist (e.g. "flex, extend,
flex"). If any deviation in performance occurred (movement performed below 50% of the range
of movement, slower, with synergistic movements), selectivity was regarded as "impaired" (1
point). The score "unable" was given, if no joint movement could be made or
mass-synergy-patterns occurred. The total score is obtained by adding the score obtained from
the joint levels to a maximum of 10 points for each limb. Testing procedures were
standardized in regards to the assessment guidelines. All tests were carried out by the same
two physiotherapists, one assessing and one assisting.
SMC of each joint movement was scored on a three-point ordinal scale. SMC was scored as in
addition total SCALE score (ST) was included statistical analysis.
3.2.2.5. Video Based Observational Gait Analysis Participants and their parents were informed
about the evaluation and then VBOGA was performed in order to evaluate their walking with
EVGS. High resolution (HD) and high frame rate (60 frames per second) Nikon Coolpix S100
camera, SanDisk 16GB memory card and tripod stand were used for recording walking trials. The
camera were located at the center of a 1m x 10m walkway. Its height was adjusted considering
the pelvis height of the individuals. Individuals were asked to wear comfortable clothes,
e.g.; tight shorts and athletes. In case of occluded superior anterior and superior posterior
spina iliac (SIAS and SIPS), shorts were adjusted so that anatomic landmarks visually
observable. All trials were obtained for bare foot walking.
The camera was placed 3m away from the middle of the walkway for video recording. Subjects
were asked to walk at their normal pace and looking forward. The evaluated cycles were taken
approximately 3-meter part in the middle of the 10-meter walkway. where the steps where the
subjects gained closest to the normal gait and gained natural walking speed, were taken into
consideration while determining the steps taken into consideration. The lower extremity,
which was close to the video camera, was evaluated. The proper trial was selected via
checking all videos. The video files taken for subject played and investigated slow play mode
and the best ones were selected for evaluation. The events were got by investigating proper
time frame using frame-by-frame play property of Adobe Premiere Pro CC 2018 video editing
software.
1.1. Statistical Analysis
IBM SPSS ( Statistical Package Analyze for Social Sciences ) Statistics version 25.0 software
was used for statistical analysis of the findings. The suitability of the variables to normal
distribution was determined by Kolmogorov-Smirnov / Shapiro-Wilk tests. The relationships
between the variables were analyzed using the Spearman correlation test as they were not
suitable for normal distribution. Cohen correlation classification was used to define the
strength of the correlation.The twenty three participants were above the minimum sample size
needed to ensure a power of 95% confidence level.