Objective: This study aims to investigate, whether children with clubfeet are facing difficulties in daily life on activity*s and participation, two domains of the ICF, comparing to their age-mates without clubfeet.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Walking distance (6MWT), (main parameter)
Secondary outcome
Jumping power,
-Sprint (10x 5 m sprint test),
-Motor performance in general (M-ABC2)
-Feeling of self-competence (CBSK-M).
-The functional status of the foot will be measured with the clubfoot
assessment protocol(CAP).
Background summary
Rationale: The idiopathic clubfoot is a congenital birth deformity with an
incidence of 200 a year in the Netherlands. Treatment is in hands of a
specialized orthopaedic surgeon, whose first aim is to correct the anatomical
structures. In the past decennia different methods are used and these days
conservative treatment seems to be the first option: A series of casts followed
in 95 % by a tenotomy and thereafter a foot abduction brace for a period of
four years, according the principles of dr. Ponseti, is at the moment world
wide the first choice of treatment. Treatment starts soon after birth.
According to the international classification of Function Disability and
Health(ICF), correction of anatomical structures and function will be obtained
in order to improve performance of daily activities and participation in sport
without pain and stiffness. Most studies compare the outcome of the different
treatment methods with correction of the anatomical structures and mobility as
outcome parameter. Even if the anatomical correction is satisfactory, we still
find some differences compared to children without clubfeet in the clinical
presentation: a smaller foot, a thinner calf, reduced muscle strength and a
difference in mobility of the ankle and foot. Whether these differences in body
structure and function also influence the child*s motor-activities and
participation is not known. The study of Andriesse at al. is so far the only
one, who investigated children with clubfeet on their motor performance.
Andriesse also developed an instrument, the clubfoot assessment protocol (CAP),
that measures not only the mobility, but also muscle function and activities.
From practical experience we know, that children with clubfeet can face
difficulties in daily life activities . What exactly these problems are and
whether we can influence them with training is not yet known.
Study objective
Objective: This study aims to investigate, whether children with clubfeet are
facing difficulties in daily life on activity*s and participation, two domains
of the ICF, comparing to their age-mates without clubfeet.
Study design
Study design: This study is an observational matched pair control study. We
compare the motor performance of primary school children with uni-or bilateral
clubfeet with their age-mates without clubfeet by asking them to do some tests
on different activities, as walking distance (6MWT), jumping force, sprint (10x
5 m sprint test) , motor performance in general (M-ABC2) and feeling of
self-competence (CBSK-M). The functional status of the foot will be measured
with the clubfoot assessment protocol(CAP).
The non-clubfoot children will be matched according to age, length, weight and
gender.
For statistical analyses will be used the Fisher*s exact t-test , the Spearman
correlation coƫfficient and the Mann Whitney U-test.
Every child will be tested once.
The test per child will take approximately 2 hours.
The testers all have test experience.
There are two test locations. Rotterdam and Deventer for the convenience of the
subjects.
Study burden and risks
All test performed are within the normal activity level of children of that
age. There is no special burden to perform the tests and the risks associated
with participation are none.
Nico Bolkesteinlaan 75
7416 GC Deventer
Nederland
Nico Bolkesteinlaan 75
7416 GC Deventer
Nederland
Listed location countries
Age
Inclusion criteria
Children with congenital talipes equinovarus between 4-12 years old.
Bi-, or unilateral anatomical corrected clubfoot
Volunteered to take part and parents signed an informed consent form.
Their controls with same age, weight, height and gender.
Exclusion criteria
Children with CTEV and comorbidity, which could influence their motor ability, like arthrogryposis or Down syndrom.
Design
Recruitment
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 | NL32904.072.10 |