Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05957783 |
Other study ID # |
Cerebralpalsy |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 3, 2021 |
Est. completion date |
April 13, 2023 |
Study information
Verified date |
July 2023 |
Source |
Istanbul University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
İntroduction The upper limb can be involved in children with cerebral palsy (CP), while the
lower limb is more commonly affected. Little is known regarding the alterations in the upper
limb kinematics after the orthopedic surgery of the lower extremity during gait. This study
aimed to evaluate the differences in the upper limb kinematics in children with CP between
preoperative and postoperative parameters.
Description:
Metods The study group included 30 children with CP (17 diplegics, 13 hemiplegics; mean age =
12,9 years, range =5-16 years; 18 boys, 12 girls) and the control group consisted of 29
healthy children (15 boys, 14 girls; mean age = 10,2 years, range=5-15 years). Video-based
gait analyses of all children were retrospectively evaluated. The follow-up period for the 30
cerebral palsy children included in the study, based on the date of the latest walking video
after surgery, was an average of 3.2 ± 1.5 years. The included patients were those who had
undergone surgery on the lower extremity (Achilles tendon lengthening, varus derotation
osteotomy, periacetabular osteotomy, gastrocnemius release, hamstring release, midfoot
osteotomies) without any surgical intervention on the upper extremity and without contracture
in the upper extremity. On April 28, 2023, the ethical committee decision 2023/801 was
obtained from the Istanbul University Istanbul Medical Faculty Department of Orthopedics and
Traumatology.
The inclusion criteria were as follows: diplegic or hemiplegic patients with surgical
treatment of the lower extremity, no previous upper extremity surgery, and no contracture in
the upper extremity. The exclusion criteria were: incomplete preoperative or postoperative
data in the gait analysis records, walking with support or assistance during the gait
analysis, and poor video quality that would not allow for measurement. The patients'
preoperative and postoperative videos from the gait analysis laboratory and their medical
records were retrospectively reviewed. Among the 300 patients who met the inclusion criteria
from the 12,567 gait analysis data points, 76 had missing preoperative videos, 87 had missing
postoperative videos, 55 were walking with parental assistance, and 52 had video quality that
did not allow for measurement.
Coronal and sagittal view videos from the gait analysis were used for evaluation.The
preoperative and postoperative videos of the patients were opened on a computer using the AVI
or MP4 format and imported into the Kinovea program. The program allowed for slow motion,
fast-forward, pause, and angular analysis of the movements in the videos. Using the program,
the videos were paused at the initial contact (1), loading response (2), midstance (3),
terminal stance (4), pre-swing (5), early swing (6), mid-swing (7), and terminal swing (8)
phases in the sagittal plane, and the following angles were measured: the angle between the
forearm axis and the third metacarpal axis (wrist sagittal plane angle), the angle between
the humerus axis and the forearm axis (elbow sagittal plane angle), the angle between the
humerus axis and the vertical line drawn on the ground (shoulder sagittal plane angle), the
angle between the line drawn on the sagittal plane of the trunk and the vertical line on the
ground (trunk sagittal plane angle), and the angle between the line drawn on the sagittal
plane of the head and the vertical line on the ground (head sagittal plane angle). In the
coronal plane, the videos were paused at initial contact and midstance, and the following
angles were measured: the angle between the humerus axis and the vertical line drawn on the
ground (shoulder coronal plane angle), the angle between the line drawn on the axis of the
trunk and the vertical line on the ground (trunk coronal plane angle), and the angle between
the line drawn on the coronal plane of the head and the vertical line on the ground (head
coronal plane angle). In hemiplegic patients, the affected side was considered the patient
side, and the unaffected side was considered the healthy side. In the diplegic group, the
more affected side was considered the patient side, and the other side was considered the
healthy side. If both sides were equally affected, the assignment was randomized between
patient and healthy. In the control group, the right upper extremity was assigned as patient
side, and the left upper extremity was assigned as healthy.To evaluate the efficacy of the
surgery, the Edinburgh score was calculated in patients pre-and postoperatively.