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Cerebral PalsyNCT02193386

Evidence-based Physical Therapy in Children With Cerebral Palsy

A study testing Intervention period in people with Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 4 to 9 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Intervention period
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteBelgium
Study dates
Sep 2010to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Cerebral Palsy
  • Age 4- 9 y
  • Gross Motor Function Classification I-III (ambulant)

Who cannot join

  • Severe associated problems limiting participation to the programs
  • Severe musculoskeletal limitations

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • University Hospital Leuven (Pellenberg) - Reference centre for children with Cerebral Palsy

    Pellenberg, Flanders, 3212

Other trials in Belgium

About this study

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.

Read the detailed description

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.

Conditions
Cerebral Palsy
Being tested
No intervention, no follow-up, only registration, Intervention period
Keywords
Cerebral Palsy, Physical Therapy, gait analysis, gross motor function
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention, no follow-up, only registrationOther

    Usual Care

  • Intervention periodOther

    Predefined intervention program

Study groups in NCT02193386
Study groupRoleWhat they receive
Usual CareActive comparatorNo intervention, no follow-up, only registration of usual therapy
Receives: Other: No intervention, no follow-up, only registration
Intervention periodExperimentalPredefined, evidence-based program and support
Receives: Other: Intervention period

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Gross Motor Function Measure - 88

    Measured: baseline, after 10 weeks of usual care and after 10 weeks of intervention

Secondary outcomes (1)
  1. Change in three-dimensional gait analysis

    Gait Profile Score, Movement Assessment Profiles and time-and distance parameters

    Measured: baseline, after 10 weeks of usual care and after 10 weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2014 (estimated)
  2. Study startSep 2010
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02193386
Sponsor's protocol ID
S51880
Other IDs
ML5982
Status last verified
Sep 2010
First submitted
10 Jul 2014
Last updated
17 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Intervention period in people with Cerebral Palsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gross Motor Function Measure - 88 (time frame: baseline, after 10 weeks of usual care and after 10 weeks of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.

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