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

Spastic Diplegia Cerebral Palsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166541
• Other study ID #: Forssberg_KI_1
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spastic Diplegia Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
Ukraine	International Clinic of Rehabilitation	Truskavets	Lviv

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	International Clinic of Rehabilitation, Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Box and Blocks test is used to measure change over time	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.	Baseline, 2 weeks, 6 months
Other	Range of motion is used to measure change over time	Range of motion measurement with goniometer in wrist, elbow, hip, knee and ankle joints.	Baseline, 2 weeks, 6 months
Other	Boyd and Graham´s Selective Motor Control Scale is used to measure change over time	Performance of voluntary active ankle dorsiflexion according the ordinal scale, Boyd and Graham´s Selective Motor Control Scale.	Baseline, 2 weeks, 6 months
Other	NeuroFlexor is used to measure change over time	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.	Baseline, 2 weeks, 6 months
Other	Questionnaire is used to measure change over time	Questionnaire of treatment efficiency, filled in by parents.	2 weeks, 6 months
Primary	Gross Motor Function Measure 66 (GMFM 66) is used to measure change over time	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.	Baseline, 2 weeks, 6 months
Secondary	Muscle tone testing using Modified Ashworth Scale is used to measure change over time	Estimation of muscle tone during rapid passive extension of the tested muscle-groups according to an ordinal scale.	Baseline, 2 weeks, 6 months