The aim of this study is to investigate whether the new joints for the sc-kevo's can be effectively operated by the patient, and whether a minimal hip extensor strength is needed to operate the joints succesfully. Secondly, the effect of theā¦
ID
Source
Brief title
Condition
- Muscle disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effective use in daily life of the two new sc-kafo's in patients with
quadriceps weakness.
Secondary outcome
1) Energy expenditure during walking: Oxygen cost per meter
2) Spatio-temporal parameters of gait (velocity, cadence, step length)
3) Kinematic en kinetic parameters of gait (jiont angles en moments of the
ankle, knee, hip and trunk)
4) Comfort and experienced functioning with the new sc-kevo's.
Background summary
Knee-ankle-foot-orthoses (KAFO*s) are prescribed for individuals with
significant weakness of the knee extensors. Until recently patients were given
a knee-ankle-foot orthosis (KAFO) with locked knee hinge to assure stability
during walking with paresis of the quadriceps. This leads to a compensational
gait resulting in increased energy cost of walking compared to a locked knee
hinge. To reduce the increased energy expenditure when using a KAFO the *stance-
control KAFO* (SC-KAFO) was developed. These devices are designed to allow free
flexion of the knee in swing, while providing full stability in stance by
automatically locking on intitiation of the stance phase of gait. Recent
advances in orthotic technology have led to the development of several new
stance-control knee joints. To optimize the effectiveness and use of newly
designed assistive devices, thorough evaluation is of importance. Two recently
developed new joints for custom made SC-KAFO*s with two different locking
mechanisms, are objectively evaluated in this pilot study. Improving physical
functioning is one of the main aims of rehabilitation treatment and improving
walking ability is therefore an important aim in this patient group.
Study objective
The aim of this study is to investigate whether the new joints for the
sc-kevo's can be effectively operated by the patient, and whether a minimal hip
extensor strength is needed to operate the joints succesfully. Secondly, the
effect of the new joints for the sc-kevo's on gait is evaluated and compared to
walking in the old orthotic condition.
Study design
A cross-over (pilot) study.
Intervention
Walking with two new types of stance-control, knee-ankle-footortheses. Each new
sc-kevo will be worn for a period of 4 weeks, at the end of this 4-week period
the evaluation will take place by using questionnaires and performing walking
tests.
Study burden and risks
Patients will attend the department of rehabilitation of the AMC 8 times. Five
of these visits are for measuring, fitting and handing out of the new orthesis.
Three of the visits are for the evaluation and gait assessemnts of the old and
new orthosis. During the first assessment visit a short clinical examination
will take plase. On each visit a questionnaire will be completed and walking
tests will be performed.
Walking (in daily life) with the new orthoses may cause more tiredness in the
beginning of using the new orthosis. The workload of the different tests is
possible
if enough rest is taken between the different tests.
Meibergdreef 9, Postbus 22660
1100 DD Amsterdam
Nederland
Meibergdreef 9, Postbus 22660
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1) quadriceps muscle weakness, 2) Currently successful users of a KAFO with locked joint or a SC-KAFO, 3) ability to walk 6 minutes, 4) age 18-70
Exclusion criteria
Co-morbid disease that limits physical exercise tolerande or limits the patient in visiting the hospital to participate in the study protocol.
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 | NL16251.018.07 |