Cerebral Palsy Clinical Trial
Official title:
Evidence-based Practice and Its Effectiveness in Physical Therapy Treatment of Children With Bilateral Spastic Cerebral Palsy.
The study aims to evaluate evidence-based practice behavior in usual care physical therapy in Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy program based on evidence-based guidelines to the effects of a period of usual care. It is hypothesized that supporting therapists by providing a predefined evidence-based intervention program, will result in an improved treatment outcome compared to the usual care physical therapy.
Participants A convenience sample of 16 children will be recruited at the Cerebral Reference
Centre of the University Hospital Pellenberg. Children will be included when they are
diagnosed with bilateral spastic CP, aged between 4 and 9 years and a Gross Motor Function
level between I and III. Children are excluded when they received Botulinum Toxin A
injections within the past six months, orthopedic surgery in the past or had severe
associated problems that limited participation to therapy (blindness, deafness, severe
cognitive limitations or autism).
Design All children will start the study with a registration period. During this period, the
children's usual physical therapy (UC) will be registered using a diary. Immediately
following the UC period, children will be enrolled into a predefined intervention program
(IP).
Both the period of UC and IP will have a duration of 10 weeks. Before and after both
periods, children will be evaluated using the Gross Motor Function Measurement (GMFM-88) and
three-dimensional gait analysis (3DGA).
Therapy interventions During the period of UC, no specific intervention will be provided.
Children will receive the frequency, intensity and contents of therapy as they usually
receive by their own private physical therapist. A diary will be provided to the child's
physical therapist. The diary contains session forms, designed for the therapist to
carefully register the contents of therapy after each session.
In the session forms, the therapist will note down how much time of the therapy session will
target problems at the different levels of the ICF. At the level of body structure and
function, the time spent on muscle length and muscle strength will be registered. For muscle
length, the therapists are asked to report the targeted muscles, the number of repetitions,
the duration of stretch and treatment modality (activo, activopassivo or passivo). About
muscle strength, therapists will note the specific muscle that was trained, the intensity
(number of repetitions and resistance) and whether the exercise was performed as analytical
(single-joint) or functional (multiple-joint) muscle work. Concerning activity level, the
specific functional activity that was practiced and the averaged position in which this was
performed, will be registered. Finally, the therapist will be asked to report whether any
problems at participation level are specifically addressed.
During the period of UC, the therapist will not be contacted and no instructions or advice
will be provided regarding physical therapy treatment of the child.
Intervention period
Immediately following the UC period, children were enrolled into a predefined intervention
program (IP), designed by the first and third author of the study. The programs will be
executed by the child's personal physical therapist, who will agree to precisely follow the
prescribed program. Similar as for the UC program, the children will receive the frequency
of therapy as they usually receive by their own private physical therapist. Two different
types of programs were designed. Ten children received an individually defined, targeted
program tailored to the individual needs of the child and six children received a general
program based on general age-appropriate treatment aims for children with bilateral spastic
CP. For an extensive description of the differences and similarities between both types of
intervention programs, the authors refer to our previous intervention studies. All
intervention programs have two major common features. The first central and common aspect in
the intervention programs was that basic principles regarding evidence-based training were
respected. All programs consist of a predefined set of exercises to improve strength,
selectivity and mobility and a set of functional exercises. Thereby, stretching is
prescribed as three repetitions of 30 seconds and strength training was prescribed in series
of three times 12 to 15 repetitions. Functional exercises are not restricted to a specific
repetition number. As appropriate, all intervention programs will contain more than 50% of
exercises at activity and participation level. The second major common feature in the
intervention programs is the support and follow-up to the therapist. At the start of the
intervention study, therapists will be visited and the prescribed program will be thoroughly
explained. All exercises will be provided in a clear and structured way, with specific
instructions regarding anatomical position, sets and repetitions. The specific exercises
will be discussed and demonstrated if necessary. During the second or third week, the
therapist will be contacted by phone or email to discuss the progress of the program and the
possible needs to change and adjust exercises. Additionally, a follow-up visit will be
organized around halfway through the program. During this visit, the program will again
discussed and the therapist performed a regular therapy session using the program, in
attendance of the first author of the study. Difficulties in performance were discussed and
if necessary, some exercises were demonstrated. The opportunity for feedback on handling or
position was thereby provided.
Due to these common aspects in our programs, and because previous data analysis revealed
that the overall effects of both programs were not found to be significantly different, we
can test our hypothesis regarding the influence of evidence-based support on the pooled
data-set.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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