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Evidence-based Physical Therapy in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02193386
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborators:
KU Leuven
University Ghent
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: No intervention, no follow-up, only registration Other: Intervention period Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evidence-based Practice and Its Effectiveness in Physical Therapy Treatment of Children With Bilateral Spastic Cerebral Palsy.
Study Start Date : September 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arm Intervention/treatment
Active Comparator: Usual Care
No intervention, no follow-up, only registration of usual therapy
Other: No intervention, no follow-up, only registration
Usual Care

Experimental: Intervention period
Predefined, evidence-based program and support
Other: Intervention period
Predefined intervention program




Primary Outcome Measures :
  1. Change in Gross Motor Function Measure - 88 [ Time Frame: baseline, after 10 weeks of usual care and after 10 weeks of intervention ]

Secondary Outcome Measures :
  1. Change in three-dimensional gait analysis [ Time Frame: baseline, after 10 weeks of usual care and after 10 weeks intervention ]
    Gait Profile Score, Movement Assessment Profiles and time-and distance parameters



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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193386


Locations
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Belgium
University Hospital Leuven (Pellenberg) - Reference centre for children with Cerebral Palsy
Pellenberg, Flanders, Belgium, 3212
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
University Ghent
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02193386    
Other Study ID Numbers: S51880
ML5982 ( Registry Identifier: UZ Leuven )
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: September 2010
Keywords provided by Universitaire Ziekenhuizen Leuven:
Cerebral Palsy
Physical Therapy
gait analysis
gross motor function
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases