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NCT Number: NCT02166541

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

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.

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Key information

Conditions

Spastic Diplegia Cerebral Palsy Cerebral palsy, spastic, diplegic

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, Ukraine

About this study

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;

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCSK

Procedure

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.

Traditional spinal manipulation

Procedure

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

INRS

Procedure

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • International Clinic of Rehabilitation, Ukraine

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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