Primary:1. Do twelve weeks of MegaPower training effectively accomplish patient-tailored participation and activity goals in ambulant children with CP, when compared to their usual care? Secondary:1. Do twelve weeks of MegaPower training improve…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research outcome is an improvement in participation and activity,
measured through Goal Attainment Scaling (GAS). Using the GAS, patient-tailored
goals will be set up and evaluated using a Likert scale with a reach from -3
(decline) to +2 (much more improvement than original goal).
Pre-baseline, the children will undergo the mobility questions of the Canadian
Outcome Performance Measure (COPM) together with a therapist. The COPM is
especially suited to identify and order personal mobility goals on
participation and activity level. After identifying these goals, 1-3 GAS-goals
will be written down on both participation and activity level. The child will
then have to order their goals and choose a primary goal for both participation
and activity. All GAS-goals will be (re-)evaluated at t = 12 weeks (end of
intervention), t = 24 weeks (halfway follow-up), and t = 36 weeks (end of
follow-up). In case a chosen primary goal cannot be accurately measured or
defined using the Likert scale, a secondary goal will become the new primary
goal. Only the primary goals will be used for statistical analysis.
Secondary outcome
1. Parent-reported mobility (questionnaires); measured using the Gait Outcomes
Assessment List (GOAL) and Mobility Questionnaire (MobQues28).
2. Physical tests for the following paramaters
a. Walking speed -> 1-minute walk test
b. Aerobic endurance -> 10m shuttle run test
c. Anaerobic capacity -> Muscle Power Sprint Test
3. Body composition; measured using bioelectrical impedance analysis (BIA).
4. Dietary intake at baseline (questionnaire); measured using a 3-day food
diary in which parents have to track the nutritional intake of their child
during 2 week days and 1 weekend day.
5. Physical activity and sleep, measured over a 7-day period using a
wrist-wearable accelerometer.
6. Self-perception of the child (questionnaire); measured using Harter's
Self-Perception Profile for Children on the domains of social competence,
athletic competence, and global self-worth.
7. General baseline characteristics (questionnaire); including:
o Age, height, weight, BMI, gender, Gross Motor Function Classification System,
CP type, Amsterdam Gait Classification, Selective Control Assessment of Lower
Extremities, type of education, education level of their parent(s), use of
ankle-foot orthoses.
8. Process evaluation (also see 'aanvullende opmerkingen'). As part of the
process evaluation we will also measure parental satisfaction regarding the
MegaPower training.
Background summary
Cerebral palsy (CP) is the most common cause of impaired mobility amongst
children. In the Netherlands, approximately 25.000 people are physically
impaired as a result of CP. CP is a lifelong disorder that originates from
brain-related damage or deviations that occur before, during, or short after
child birth. Children that suffer from CP especially struggle with walking.
This is in part due to a combination of lowered strength and spasticity in
their lower limbs. As a result of their movement disorder, children with CP
struggle to participate with typically developing peers during school, sports,
and their free time.
Physiotherapy may improve gait, which also improves participation of children
with CP. These children with CP require mobility exercises specific to their
individual disorder and treatment question(s). Recently, we showed in a small
study that Functional Power Training (FPT) according to the so-called
'MegaPower protocol' causes a large increase in walking speed, aerobic
enduance, and anaerobic capacity in children with CP after twelve weeks of
intensive FPT. Due to the heterogeneity of children with CP, every participant
was used as their own control in this study in a so-called double-baseline
design. The results of this non-randomised study need to be confirmed in a
larger, randomised, multicenter study to implement MegaPower training as
regular treatment for ambulant children with CP. Additionally, we want to
investigate what factors best identify which ambulant children with CP benefit
most from MegaPower training.
The Power2Walk study will provide the framework for whether, and to what
extend, MegaPower training has added value in the physiotherapical treatment of
children with CP in comparison to their usual care. Additionally, we want to
explore what factors best identify which ambulant children with CP benefit most
from MegaPower training. Furthermore, we want to investigate whether the
effects of the MegaPower training are maintained after 12 and 24 weeks of
follow-up. Lastly, we want to evaluate whether the MegaPower training was
implemented as intended at the participating research centers. We expect the
MegaPower training to effectively improve participation in children with CP
when compared to their usual care.
Study objective
Primary:
1. Do twelve weeks of MegaPower training effectively accomplish
patient-tailored participation and activity goals in ambulant children with CP,
when compared to their usual care?
Secondary:
1. Do twelve weeks of MegaPower training improve walking ability, aerobic
endurance, and anaerobic capacity in ambulant children with CP, when compared
to their usual care?
2. What factors best identify which ambulant children with CP benefit most from
twelve weeks of MegaPower training?
3. To what extend was MegaPower training implemented as intended in the
participating research centers?
4. Are the effects of MegaPower training maintained after 12 and 24 weeks of
follow-up?
Study design
This study is a single-blind randomized controlled parallel trial with a 24
week follow-up. Half of the children will follow the MegaPower training three
times a week for twelve weeks (intervention group). The other half will receive
their usual care during the same time period, which consists for example of
physiotheraphy (control group). During the follow-up, the intervention group
will receive 24 weeks of usual care. Simultaneously, the control group will do
twelve weeks of MegaPower training during the follow-up, followed by twelve
weeks of usual care. This is because we believe it is important that the
control group also receives the MegaPower training.
Intervention
Intervention group:
The MegaPower training is a 12 week long functional power training program in
which children will perform functional power training 3 times a week together
with a personal trainer. During the intervention, training volume will be
influenced by training weight, velocity of movement, and amount of repetitions.
The training program has the following characteristics:
1. (Weighted) functional exercises like walking, running, and walking stairs.
2. High velocity movements.
3. Progressive overload.
Prior to and during the training, a sports consultant makes a plan together
with parent and child to find a fitting place where the child can stay
physically active after the training (for example a sports club or group). We
do this because we want to implement the results of the study in day-to-day
life. Both at 12 and 24 weeks during the follow-up, parent and child will visit
again to measure whether the effects on participation are durable.
Control group:
The control group will receive their usual care for 12 weeks (non-intervention
group). This usual care consists of physiotherapy appointments for example.
Important to mention is that the control group will also follow MegaPower
training during the first 12 weeks of the follow-up, because we believe it is
important to also provide the training to this group.
Study burden and risks
1. Burden:
The burden consists of three components:
- Participation in MegaPower training: Total burden of 36 hours spread over 12
weeks of training with 3 moments of training per week that each last 1 hour.
- Measurement days: Total burden of 5 hours spread over 4 measurement days in
total. The first measurement day takes 2 hours. The other measurement days each
take 1 hour. After every 12 weeks of the study, a week is planned to take these
measurements. This adds up to 3 x 12 + 4 = 40 weeks.
- Parent questionnaires: Total burden of 2.5 hours spread over 40 weeks.
Questionnaires can be filled out at home.
The total burden for the children is 41 hours over 40 weeks. The total burden
for the parents is 2.5 hours over 40 weeks.
Important to mention is that MegaPower training is part of the usual care that
these children receive. The added burden that children will experience as a
result of the training is exactly the same for children that do not participate
in the study, since they would follow the training regardless. Solely the
measurement days and parent questionnaires are an added burden as a result of
participating in the study.
2. Risks:
The risks are very low. The risks of the MegaPower training are not larger than
those of usual care, although participants may experience some muscle ache and
fatigue during the beginning of the training program. These go away after a
short amount of time. Additionally, it should be mentioned that the BIA sends
an unnoticable electric pulse through the body. The BIA then measures impedance
accross the body. BIA has a small risk for participants that wear an electronic
medical implant, like for example a pacemaker. Parent and child will be asked
if the child has an electronic medical implant before the measurements take
place. Participants that wear an electronic medical implant, will not undergo
any measurements using the BIA. The BIA is completely safe for all other
participants. Important to mention is that these children would participate in
the MegaPower training, even when they would not participate in the study. This
is why participation in this study specifically does not introduce any added
risks for these children.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Children with cerebral palsy or a related non-progressive disorder between
the ages of 4 and 12.
- Gross Motor Function Classification System (GMFCS) level I - III.
- Parents and/or children have a treatment question related to either walking
ability and/or participation of their child.
Exclusion criteria
- Participants that suffer from a progressive neurological disorder.
- Treatment with botulinum toxin and/or serial casting in lower extremities
planned during the study.
- Treatment with botulinum toxin in the 12 weeks prior to the study.
- Treatment with serial casting in the 3 weeks prior to the study.
- Children that underwent a selective dorsal rhizotomy in the 12 months before
participation in the study.
- Children that underwent orthopedic surgery on their lower extremities in the
12 months before participation in the study.
- Children that have already received MegaPower training in the last 4 months
before participation in the study
- Children for whom walking is not their preferred method of locomotion (yet).
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL85905.018.23 |