The purpose of this study is to examine whether walking ability and plantar flexor strength of young children with CP who follow functional power training improve more compared to usual care.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters;
The objective primary outcome to measure the effect of the MegaPower training
is the Muscle Power Sprint Test (MPST). The Goal Attainment Scaling (GAS) is
the subjective, reported by the parents, primary outcome.
The MPST is a 6 times 15 meter sprint test. Between the 6 sprints is a 10 sec
break in which the child can turn and be ready for the next sprint. The time
used for each sprint is measured with 0.01 second precision. Together with body
height and weight power will be calculated and expressed in Watts. The MPST
measures the anaerobic capacity of the child expressed in mean power and peak
power. The reliability of the test is good (ICC=0.97).
With GAS the extent of reaching the treatment goal will be measured. GAS is a
sensitive, individual, evaluative measurement which describes the change of
individuals or groups after treatment (ICC = 0.86).
Secondary outcome
Secondary study parameters
The secondary study parameters on the activity and participation level of the
ICF-CY are the 1 Minute Walk Test (1MWT), 10 meter Shuttle Run Test, the
Functional Mobility Scale (FMS), the Mobility questionnaire (MoVra28), Gross
Motor Function Measure Dimension D and E (GMFM D&E), and the comfortable
walking speed determined during the gait analysis.
The 1 MWT measures the distance walked in 1 minute. The children are asked to
walk as fast as possible without running. The reliability is good (ICC=0.89
(4-5 year old children with CP), en ICC=0.94 (6-10 year old with CP). Aerobic
capacity will be measured with the 10 meter Shuttle Run Test made for children
with CP GMFCS level I and II (Reliability: ICC = 0.97 tot 0.99). The FMS is a
questionnaire to classify the functional mobility in children with CP in the
age of 4 till 18 years old (Reliability: Kappa 0.86-0.92). The MoVra28 is a
questionnaire for children from 2-13 years old to determine the extent of
problems the child has with his ambulation. The test contains 28 questions
about daily activities and has a good reliability (ICC 0.87-0.99). Gross motor
function such as standing on one leg, walking and turning, running and jumping
are measured in a standardized way with the GMFM D&E (ICC 0.87-0.99).
The secondary outcome measures in terms of body function and structures are
isometric muscle strength of the calf muscles, quadriceps and abductors and
dynamic muscle strength of the calf muscles. The isometric muscle strength is
measured with a hand-held dynamometer (microFET Hand-held Dynamometer,
Biometrics BV, Almere) (ICC 0.79 - 0.96). The dynamic muscle strength will be
measured with the unilateral heel-rise test (ICC 0.86 - 0.98).
During gait analysis the peak knee angle in Mid Stance and Terminal Stance will
be determined by observing the two and three dimensional video recordings (ICC
0.85-0.96). The Maximum Voluntary Contraction will be assessed with the
electromyography (EMG) of the calf muscles during the isometric muscle strength
measurement. Using also EMG during the gait analysis, the muscle activity
(%MVC) during walking can be determined.
Body height, body mass, probability of motor selective movements in hip, knee
and ankle, presence of catch in the lower extremities and the muscle length of
the m.gastrocnemius, m.soleus and hamstrings will be measured.
Background summary
Introduction
Children with cerebral palsy (CP) is the largest group treated in pediatric
rehabilitation. Prevalence rates of CP are about 2 per 1000 births in Europe of
which 82% has a spastic CP. Motor impairment in CP is multi-factorial and
includes problems such as spasticity, coordination problems, loss of selective
motor control and muscle weakness. Children with CP have problems with their
walking ability in terms of walking speed, duration and they fall more often
than typically developing children. Therefore, they experience more problems in
daily live and during playing. Parents and/or children often ask for help for
improving the walking ability in the clinical practice already at an early age.
Children with CP develop their walking ability and walking pattern from the
moment they start with walking till about 8 years old. It is important to guide
the children in improving their walking ability at this early stage.
In clinical practice we often see that the push off is not efficient, which
results in problems in clearance of the foot during walking and causes the many
falling incidents. Also the stride length is short because of the diminished
push off in children with CP. In typically developed walking 50-70% of the push
off is delivered by the strength of the calf muscles. Children with CP have
muscle weakness especially in the more distal muscles of the lower limbs, such
as the calf muscles.
We, therefore, developed a functional power training program, called MegaPower
training, in which they have to use maximal effort of the calf muscles during
functional and known movements such as walking, running and climbing stairs.
The velocity when performing the exercises is the velocity that is common for
the activities they encounter in daily live. The difference between power
training and the more traditional strength training programs are the higher
velocity and the functional multi-joint character of the exercises. The
children are guided carefully during the exercise by the trainer. A story about
super heroes keeps the children motivated to give their best effort during the
training.
In Reade the MegaPower training is already implemented in clinical practice.
From 2011-2012, Reade got financial support from health insurance Agis to
develop and implement the MegaPower training for children from 4-10 years with
spastic CP. Pilot results from the children trained so far at Reade seem very
positive. Before we can implement the MegaPower training at more locations, it
is important to know the real (i.e. evidence-based) effect of the MegaPower
training on the walking ability for children from 4-10 years with spastic CP.
Study objective
The purpose of this study is to examine whether walking ability and plantar
flexor strength of young children with CP who follow functional power training
improve more compared to usual care.
Study design
Procedure
This research protocol has a *double-baseline* research design. The children
that participate are their own controls by measuring their walking ability in
the 14 weeks before the training intervention starts, which is the period of
usual care. Thereafter, they follow the functional power training to be tested
in this study. Fourteen weeks after the end of the training, a follow-up test
is scheduled to assess if the potential improvement is remained.
The 'double baseline' design is chosen instead of a randomized control trial
(RCT) to increase the feasibility of the study and to measure the change within
the individual children in a better way. Parents often prefer the participate
in the intervention group above a control group in a RCT, which makes it hard
for them to participate in a study if they are not certain to get the
intervention. The number of children that are to be included will be more in a
RCT than in a 'double baseline' design, which makes the double-baseline design
more feasible. Graham et al (2012) recently described the disadvantages of a
RCT e.g. the strict inclusion and exclusion criteria of a RCT design make it
difficult for therapists and clinical practitioners to generalize the outcome
of the RCT to their patients in clinical practice. Graham et al (2012)
described the 'double baseline' design as proposed in the present study as an
alternative method in which less patients have to be measured.
Intervention
The functional power training (MegaPower training) has three elements: 1.
warming-up (10 min), 2. power training (35 min), 3. play (15 min).
Key elements of the power training are; a.) functional loaded, muti-joint
exercises like running and walking with focus on the push-off, b) the velocity
of the movement during the exercises is the same velocity as used in
daily/playing activities, c) 25 till 30 sec maximal effort will be asked of the
children, thereafter they have a resting period of 30 till 50 sec., with 6 till
10 repetitions each exercise, d) Load will increase when possible during the
weeks of the training period, e) training volume exists of load, velocity and
number of repetitions, f) to motivate the children and control the movements
during the exercises they all have a personal coach.
Study burden and risks
The only risk of participation in this MegaPower will be muscle soreness. The
frequency and severity of muscle soreness will be monitored during the
training.
Overtoom 283
Amsterdam 1054 HW
NL
Overtoom 283
Amsterdam 1054 HW
NL
Listed location countries
Age
Inclusion criteria
Children with diagnosis of predominantly spastic type of Cerebral Palsy, aged 4-10 years, being ambulant without assistive devices (GMFCS level I and II).
Parents and/or the children want to improve the walking ability of the child.
The children are able to follow instructions to perform the exercises and tests.
Exclusion criteria
Treatment with botulinum toxin A in lower limb or serial casting of lower limb less than 6 months before the MegaPower training starts.
Treatment of selective dorsal rhizotomie less than 12 months before the MegaPower training starts.
Walking is not (yet) the preferred way to move around.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL46189.048.13 |
OMON | NL-OMON21727 |