The primary objective of this study is to investigate whether protraction of the pelvis at the affected side is a compensatory mechanism to reduce out-toeing and thereby improve foot positioning during gait in patients with unilateral stable SCFE,…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Kinematic data at pelvis, hip, knee and ankle level will be gained by using the
CAREN system. Multiple consecutive steps will be evaluated. These kinematic
data will also be used to evaluate the margins of stability, which is an
adequate manner to analyse dynamic postural balance. These parameters enables
us to answer our primary research questions:
1.Is protraction of the pelvis at the affected side a compensatory mechanism to
reduce out-toeing and thereby improve foot positioning during gait in patients
with unilateral stable SCFE, treated with single screw in situ fixation?
a. Are patients with treated SCFE less able to use this compensatory
mechanism when walking/running at a higher speed?
2. Are the structural changes in the hip joint in SCFE resulting in an impaired
dynamic postural balance during normal gait and walking/running at a fixed
speed?
3. What is the effect of stable SCFE, treated with single screw in situ
fixation, on muscle activation patterns in the lower extremity and are there
difference with healthy controls?
Secondary outcome
Secondary study parameters are muscle activation patterns gained by surface EMG
during the gait analysis. The Harris Hip Score and the Borg score will be
recorded to evaluate the clinical outcome. These parameters enables us to
answer the following secondary research questions:
1. To what degree are kinematic parameters at pelvis, hip, knee and ankle level
deviating in patients with unilateral stable SCFE, managed with single screw in
situ fixation, compared with the sound side and children adolescents with no
gait pathology?
2. What is the clinical outcome of patients with unilateral stable SCFE,
treated with single screw in situ fixation, based on the Hip Injury and
Osteoarthritis Outcome Score and SF-36 and is this score correlated to the
degree of initial slip?
3. Is there a difference in the severity of tiredness between SCFE patients,
treated with single screw in situ fixation, and healthy controls directly after
the gait analysis based on the Borg CR10 score and is this score correlated to
the degree of initial slip?
Background summary
Slipped Capital Femoral Epiphysis (SCFE) treated with one screw in situ
fixation results in an altered gait. It is thought that the protraction of the
pelvis at the affected side, seen in patients with unilateral stable SCFE, is a
compensatory mechanism to reduce out-toeing and thereby improve foot
positioning during gait. This study will evaluate this hypothesis since only a
few studies are conducted evaluating gait in treated SCFE. It is also thought
that this pathology results in an impaired balance. Computer Assisted
Rehabilitation Environment (CAREN) will be used to investigate these two
questions.
Study objective
The primary objective of this study is to investigate whether protraction of
the pelvis at the affected side is a compensatory mechanism to reduce
out-toeing and thereby improve foot positioning during gait in patients with
unilateral stable SCFE, treated with single screw in situ fixation. Dynamic
postural balance will be analysed since an altered, waddling gait, is observed
in patients with treated SCFE. In addition, activity patterns of lower limb
muscles will also be evaluated using surface electromyography.
Secondary objectives are the evaluation of clinical outcomes and spatiotemporal
parameters in these patients. Kinematic results and spatiotemporal outcomes
will be compared to the sound side and healthy controls having no gait
pathology. Postural balance and muscle activation patterns will only be
compared to healthy controls.
Study design
a comparative cross-sectional case-control study.
Intervention
Walkin on the CAREN system can be seen as an intervention, since children
should walk on this specific treadmill.
Study burden and risks
The risk of CAREN based gait analysis is negligible. A safety harness provides
protection against falling. It will avoid subject falling on or off the
treadmill while performing training. The safety harness is secured with a life
line to the ceiling. The burden of the children or adolescents is minimal.
Participants will visit the MUMC+ once, where the questionnaire Hip Injury and
Osteoarthritis Outcome Score and SF-36 will be performed, Borg and NRS
scoring,physical examination and gait analysis will be performed. The whole
session will take 2 hours. Due to the nature of the study, this study can only
be done using this specific patient group.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
* Age between 8 and 21 years.
* Unilateral stable SCFE, with clinical and radiological confirmation and lateral slip angles ranging from mild (LSA <30°), moderate (LSA 30°-50°) to severe (LSA >50°) based on the method of Southwick.
* Treatment of the slip with single screw in situ fixation in the last ten years, with no evidence of major complications related to the procedure like chondrolysis, avascular necrosis and infection or slip progression.
* Follow up at our institution for at least one year.
* Ability to walk 30 minutes without aid.
* Able to speak, understand and read the Dutch language.
Exclusion criteria
* Clinical or radiological evidence of a contralateral slip or an endocrinopathy as underlying cause of SCFE.
* Revision surgery.
* Other pathology leading to gait alterations.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56402.068.16 |