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

Karolinska Institute

Status: Completed

Conditions: Spastic Diplegia Cerebral Palsy

Treatments: Procedure: BCSK; Procedure: INRS; Procedure: Traditional spinal manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02166541

Forssberg_KI_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

INRS with BCSK

Experimental group

Description:

"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.

Treatment:

Procedure: INRS

Procedure: BCSK

INRS with traditional spinal manipulation

Sham Comparator group

Description:

"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.

Treatment:

Procedure: Traditional spinal manipulation

Procedure: INRS

Total population

Experimental group

Description:

All participants (i.e., both arms described above INRS with BCSK or traditional spinal manipulation)

Treatment:

Procedure: Traditional spinal manipulation

Procedure: INRS

Procedure: BCSK