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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT02166541 |
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Date of registration:
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09/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of INRS With BCSK in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.
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Scientific title:
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Evaluation of "Intensive Neurophysiological Rehabilitation System" (INRS) With "Biomechanical Correction of the Spine According to Kozyavkin" (BCSK) in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial. |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02166541 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Ukraine
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Contacts
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Name:
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Hans Forssberg, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Women´s and Children´s Health, Karolinska University |
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Children with Spastic Bilateral form of Cerebral Palsy according Surveillance of
Cerebral Palsy in Europe (SCPE) criteria
- GMFCS levels II-IV
- The children should not have received previous INRS treatment
Exclusion Criteria:
- Other forms of Cerebral Palsy
- Severe epileptic syndrome
- Severe mental retardation
- Orthopedic surgery within the last year
Age minimum:
4 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spastic Diplegia Cerebral Palsy
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Intervention(s)
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Procedure: Traditional spinal manipulation
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Procedure: BCSK
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Procedure: INRS
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Primary Outcome(s)
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Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time
[Time Frame: Baseline, 2 weeks, 6 months]
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Secondary Outcome(s)
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Muscle tone testing using Modified Ashworth Scale is used to measure change over time
[Time Frame: Baseline, 2 weeks, 6 months]
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Secondary ID(s)
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Forssberg_KI_1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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