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

NCT02166541 | Completed

• 1 other identifier: Forssberg_KI_1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spastic Diplegia Cerebral Palsy

Keywords

cerebral palsy, spastic, diplegic,; children,; intervention study,; manipulation, spinal; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle tone testing using Modified Ashworth Scale is used to measure change over time

  Baseline, 2 weeks, 6 months

Other Outcomes (5)

• Box and Blocks test is used to measure change over time

  Baseline, 2 weeks, 6 months

• Range of motion is used to measure change over time

  Baseline, 2 weeks, 6 months

• Boyd and Graham´s Selective Motor Control Scale is used to measure change over time

  Baseline, 2 weeks, 6 months

Study Arms (3)

INRS with BCSK

EXPERIMENTAL

"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; Procedure: INRS

INRS with traditional spinal manipulation

SHAM COMPARATOR

"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; Procedure: INRS

Total population

EXPERIMENTAL

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

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

Interventions

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.

INRS with BCSK; Total population

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 with traditional spinal manipulation; Total population

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".

INRS with BCSK; INRS with traditional spinal manipulation; Total population

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Other forms of Cerebral Palsy
• Severe epileptic syndrome
• Severe mental retardation
• Orthopedic surgery within the last year

Sponsors & Collaborators

• Karolinska Institutet: lead
• International Clinic of Rehabilitation, Ukraine: collaborator

Study Sites (1)

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, Ukraine

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic

Study Officials

• Hans Forssberg, Professor

  Department of Women´s and Children´s Health, Karolinska University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 18, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

UA (1)