The main objective of this exploratory study it to determine the effectiveness of a 5-week functional gait training on the C-mill to improve gait adaptability in children and adolescents with CP. t The intervention will also be evaluated on activity…
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the gait adaptability measure with stepladdertest.
The score includes measurement time and number of failures.
Secondary outcome
Secondary outcomes are determined during an obstacle avoidance task and motor
plan and online correction tasks on an instrumented treadmill. In addition
motor control (muscle coordination) during gait will be assessed. Furthermore,
the following clinical tests are performed: a
standardized obstacle course based on the obstacle subtask of the Emory
Functional Ambulation Profile, the 10 meter walking test, functional muscle
strength test (FSM-CP). Perceived athletic competence will be measured with the
Motorische Competentiebelevingsschaal voor Kinderen(CBSK-M), Self-perception of
performance in everyday living with the Canadian Occupational Measure (COPM)
and the Quality of life with the NL-KIDSCREEN-52.
Background summary
Children and adolescents with Cerebral Palsy (CP) experience difficulties in
their gait, which affects participation in ADL-activities and has negative
effects on their quality of life. The current study aims to improve gait in
complex, but daily, situations of children and adolescents with CP who can walk
independently (GMFS I and II). Walking over level surface and with full
attention is normally not an issue for these children, however, problems occur
when they have to adapt their gait to changes in the environment. This is
difficult, even for those with high levels of functioning. Fast and adequate
adaptations of gait to the challenges in the environment is crucial for safe
mobility during ADL situations and sports and games. The target group of our
study participates in regular education, because of which differences with
peers at school are more obvious in the busy classroom, at the schoolyard of
during sports- and game activities. Parents and therapists emphazise the need
to interventions that specifically focus on the improvement of this important
aspect of gait.
Study objective
The main objective of this exploratory study it to determine the effectiveness
of a 5-week functional gait training on the C-mill to improve gait adaptability
in children and adolescents with CP. t The intervention will also be evaluated
on activity and participation level and quality of life. Secondary, a first
step will be made to investigate factors affecting the effect of the
intervention to be able to identify who will benefit most from this functional
gait training in the future.
Study design
Randomized controlled trial with a wait-list control group
Intervention
Functional gait training on the C-mill. The C-mill is an instrumented treadmill
with embedded force plates. On this treadmill visual stimuli can be projected.
To train gait adaptability, participants will be asked to step on targets
varying their step length, step width, step symmetry, avoid obstacles, and
react to acceleration and deceleration of the targets. The training consists of
10 sessions (45 minutes, two times a week during 5 weeks)
Study burden and risks
The burden and risks associated with participation are minor. The included
children will be asked to perform a measurement with tests and equipment that
are common in rehabilitation practice.
The participants are asked to participate in three or four measurements
(depending on the group they are referred to) of maximal 2.5 hours and 10
training sessions of 45 minutes.
All tasks are playful and, in our experience, the children enjoy performing
both the overground tasks and the measurements on the instrumented treadmill.
The treatment is aimed at improving gait adaptability in the children and
adolescents with cerebral palsy. It is hypothesized that they will benefit from
participation in this study.
Because children and adolescents with cerebral palsy and GMFCS I and II
experience problems with gait adaptability in daily life, it is important to
include this target group. It is not possible to perform this with other
patients groups, for instance adults, because the results will have no external
validity to children and adolescents with CP.
Hengstdal 3
Ubbergen 6574
NL
Hengstdal 3
Ubbergen 6574
NL
Listed location countries
Age
Inclusion criteria
- Age 6 -17 years
- Spastic, dyskinetic or ataxic Cerebral Palsy, uni- or bilateral.
- GMFCS I-II
- Referral from rehabilitation physician regarding improvement of gait
Exclusion criteria
- Surgery such as SEMLS, SDR or ITB in the past 2 years
- Botox injections in the lower extremities in the past 6 months
- When participation in the training on the C-mill is not possible due to for example epilepsy, severe visual problems, cognitive problems or temporary complaints that influence walking.
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 | NL65371.091.18 |