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Evaluation of INRS With BCSK in Children With Spastic Bilateral Cerebral Palsy: a Randomized Controlled Trial.

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ClinicalTrials.gov Identifier: NCT02166541
Recruitment Status : Unknown
Verified February 2015 by Hans Forssberg, Karolinska Institutet.
Recruitment status was:  Recruiting
First Posted : June 18, 2014
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
International Clinic of Rehabilitation, Ukraine
Information provided by (Responsible Party):
Hans Forssberg, Karolinska Institutet

Brief Summary:
A randomized control trial investigating "Biomechanical Correction of the Spine according to Kozyavkin" (BCSK) which is a part of the treatment concept "Intensive Neurophysiological Rehabilitation System" (INRS). BCSK is used with the aims to reduce muscle tone and improve gross and fine motor function in children with Spastic Bilateral Cerebral Palsy.

Condition or disease Intervention/treatment Phase
Spastic Diplegia Cerebral Palsy Procedure: BCSK Procedure: Traditional spinal manipulation Procedure: INRS Not Applicable

Detailed Description:

The study is a collaboration between the International Clinic of Rehabilitation (ICR) in Ukraine and the Karolinska Institute (KI) in Sweden. The intervention and the assessments are performed at ICR. The primary outcome measure, evaluation of gross motor function with the test GMFM 66 is filmed and the recordings are transferred to KI together with all assessment data. KI are responsible for study research design and collects, analyzes and processes all data. It is a double blinded study. Only two persons will know to which group the subject belongs, the person performing the randomization process in Sweden and the doctor performing the spinal corrections.

There are two aims of the study;

  1. To evaluate the effect of "Biomechanical Correction of the Spine" (BCSK) in children with Spastic Bilateral Cerebral Palsy.
  2. To evaluate the effect of "Intensive Neurophysiological Rehabilitation System" (INRS) in children with Spastic Bilateral Cerebral Palsy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: INRS with BCSK

"Intensive Neurophysiological Rehabilitation System (INRS)" including the "Biomechanical correction of the spine according to Kozyavkin (BCSK)".

The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary.

Procedure: BCSK
The "BCSK" is a specific technique of polysegmental spinal manipulation developed by Professor Kozyavkin based on applying quick short impulse aimed on moving intervertebral joints outside restrictive barrier.

Procedure: INRS
The "INRS" is a treatment program developed at the International Clinic of Rehabilitation where the spinal manipulation is one of several components. There may be some variation in treatment depending on the clinical situation. All children receive the main treatment components which are massage, physical therapy, warm wax and paraffin applications and low electro stimulation with a special portable device as a part of treatment called "Reflexotherapy".

Sham Comparator: INRS, traditional spinal manipulation

"Intensive Neurophysiological Rehabilitation System (INRS)" including spinal manipulation by the traditional technique.

The daily treatment for about 2 hours are in general equal for all children except for the type of spinal manipulation. Duration of all treatment will be noted in a Treatment Diary.

Procedure: Traditional spinal manipulation
Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.

Procedure: INRS
The "INRS" is a treatment program developed at the International Clinic of Rehabilitation where the spinal manipulation is one of several components. There may be some variation in treatment depending on the clinical situation. All children receive the main treatment components which are massage, physical therapy, warm wax and paraffin applications and low electro stimulation with a special portable device as a part of treatment called "Reflexotherapy".




Primary Outcome Measures :
  1. Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time [ Time Frame: Baseline, 2 weeks, 6 months ]
    The Gross Motor Function Measure (GMFM) evaluates gross motor function in children with cerebral palsy. This version, GMFM 66, contains 66 items that span the spectrum from activities in lying and rolling up to walking, running and jumping skills.


Secondary Outcome Measures :
  1. Muscle tone testing using Modified Ashworth Scale is used to measure change over time [ Time Frame: Baseline, 2 weeks, 6 months ]
    Estimation of muscle tone during rapid passive extension of the tested muscle-groups according to an ordinal scale.


Other Outcome Measures:
  1. Box and Blocks test is used to measure change over time [ Time Frame: Baseline, 2 weeks, 6 months ]
    Evaluation of fine motor skills using Box and Blocks test. The score is the number of blocks carried from one compartment to the other in one minute. Each hand is scored separately.

  2. Range of motion is used to measure change over time [ Time Frame: Baseline, 2 weeks, 6 months ]
    Range of motion measurement with goniometer in wrist, elbow, hip, knee and ankle joints.

  3. Boyd and Graham´s Selective Motor Control Scale is used to measure change over time [ Time Frame: Baseline, 2 weeks, 6 months ]
    Performance of voluntary active ankle dorsiflexion according the ordinal scale, Boyd and Graham´s Selective Motor Control Scale.

  4. NeuroFlexor is used to measure change over time [ Time Frame: Baseline, 2 weeks, 6 months ]
    Testing of muscle tone using the NeuroFlexor when applicable. The NeuroFlexor (Aggero MedTech AB, Solna, Sweden) is an instrument for objectively quantifying passive movement in wrist and finger flexor muscles.

  5. Questionnaire is used to measure change over time [ Time Frame: 2 weeks, 6 months ]
    Questionnaire of treatment efficiency, filled in by parents.



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02166541


Contacts
Contact: Hans Forssberg, Professor +46708730830 Hans.forssberg@ki.se
Contact: Emma Hjalmarsson, PT, MSc emma.hjalmarsson@ki.se

Locations
Ukraine
International Clinic of Rehabilitation Recruiting
Truskavets, Lviv, Ukraine
Sponsors and Collaborators
Karolinska Institutet
International Clinic of Rehabilitation, Ukraine
Investigators
Principal Investigator: Hans Forssberg, Professor Department of Women´s and Children´s Health, Karolinska University

Responsible Party: Hans Forssberg, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02166541     History of Changes
Other Study ID Numbers: Forssberg_KI_1
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: February 19, 2015
Last Verified: February 2015

Keywords provided by Hans Forssberg, Karolinska Institutet:
cerebral palsy, spastic, diplegic,
children,
intervention study,
manipulation, spinal
randomized controlled trial

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations