Intensive Neurorehabilitation for Cerebral Palsy (IntReh4CP)

Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial

Evaluation of effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a single-blinded randomized controlled trial with two groups.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Procedure: Intensive Neurophysiological Rehabilitation System; Procedure: Activity and care as usual

Detailed Description

Intensive Neurophysiologic Rehabilitation System (INRS) is an intensive multimodal rehabilitation system, whereby versatile and multi-faceted methods are combined with the aim of improvement of functioning and quality of life of children with CP. Treatment components are addressing different functional goals in the Body Functions domain of the International Classification of Functioning (joint mobility, muscle tone, voluntary movement, pain, intellectual functions) and Activities and Participation domains (fine hand use, walking, moving around, interpersonal interactions and family relationships.

The Intensive correction course includes up to four hours of daily training. The treatment program is tailored individually according to the patient's condition and incorporates some of the following component according to individual indications and contraindications: Physical therapy, Occupational therapy, Full body massage, Spinal manipulative therapy, Joint mobilization techniques, Paraffin and wax applications, Reflexotherapy, Strength training, Computer game therapy, Suit therapy, Vibration therapy, Treadmill training, Group session of "rhythmic gymnastics". The influence of one technique complements and potentiates other rehabilitation components.

The aim of the study is to evaluate effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a randomized controlled trial.

A single-blinded randomized controlled trial with two groups will be conducted. The experimental group will undergo treatment course according to INRS, control group will continue receive usual home activity and care while staying on the waiting list. To avoid possible information leak about patient group allocation, the study should be performed in two independent centers: Evaluation center and Treatment center. Assessments will be conducted three times: at the baseline, in 3 weeks, and 7 weeks after the baseline.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Lviv Region
    • Truskavets, Lviv Region, Ukraine, 82200
      • International Clinic of Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cerebral Palsy bilateral spastic forms,
• Age 4-12 years,
• Gross Motor Function Classification System - Levels I-IV,
• Manual Ability Classification System - Levels I-IV.

Exclusion Criteria:

• Uncontrolled epileptic syndrome,
• Severe intellectual disability,
• Uncooperative behavior,
• Surgery during ongoing year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Experimental group undergoing treatment course according to INRS	Procedure: Intensive Neurophysiological Rehabilitation System; Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.
Other: Control group; Wait-list delayed intervention. Control group continues usual activity and care while staying in the waiting list.	Procedure: Activity and care as usual; Control group continues usual activity and care while staying in the waiting list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gross Motor Function Measure score (GMFM-66)	The Gross Motor Function Measure (GMFM) evaluates gross motor function in children with cerebral palsy. The GMFM-66 version contains 66 items that span the spectrum from activities as lying and rolling up to walking, running, and jumping skills.	Baseline, 3-week, and 7-week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Manual dexterity	Manual dexterity is evaluated using Box and Blocks test. The score is the number of blocks carried by hand from one to another compartment in one minute.	Baseline, 3-week, and 7-week follow-up
Change in Daily functioning- Self-Care	Eating, grooming, dressing, bathing, and toileting skills are evaluated using Pediatric Evaluation of Disability Inventory (PEDI) Self-care questionnaire that includes 73 items, scales score is calculated.	Baseline, 3-week, and 7-week follow-up
Change in Daily functioning- Mobility	Transfers, indoor, and outdoor mobility skills are evaluated with Pediatric Evaluation of Disability Inventory (PEDI) mobility questionnaire that includes 59 items, scales score is calculated.	Baseline, 3-week, and 7-week follow-up
Change in Jebsen-Taylor hand function score	Test quantifies the time it takes for the subject to do the following standardized functional tasks with one hand: turning over cards, picking up small items, simulating feeding, stacking checkers, picking up light cans, and picking up heavy cans.	Baseline, 3-week, and 7-week follow-up
Change in ABILHAND-Kids score	The scale measures a person's ability to manage daily activities that require the use of the upper limbs. The parent is asked to fill in the questionnaire by estimating their child's performance of 21 manual activities on a 3-level scale (impossible, difficult, easy).	Baseline, 3-week, and 7-week follow-up
Change in passive range of ankle dorsiflexion	Range of motion is measured with a hand-held goniometer.	Baseline, 3-week, and 7-week follow-up

Collaborators and Investigators

• Sponsor: International Clinic of Rehabilitation, Ukraine
• Collaborators: I.Horbachevsky Ternopil National Medical University; Elita Rehabilitation Center; Rainbow Kids e.V.
• Investigators: Principal Investigator: Oleh Kachmar, MD, PhD, International Clinic of Rehabilitation, Ukraine

Publications and helpful links

General Publications

• Kachmar, O. O., Mysula, I. R., Kushnir, A. D., Fedchyshyn, B. Y., & Melekh, N. V. Effect of Professor Kozyavkin method on hand function in children with cerebral palsy. International Neurological Journal. 2020;16(1): 2-9 https://doi.org/10.22141/2224-0713.16.1.2020.197324
• Kachmar, O., Mysula, I., Kushnir, A., Voloshyn, T., Matiushenko, O., Hasiuk, M., & Hordiyevych, M. (2019). Changes in motor functions in children with cerebral palsy after the course of intensive neurophysiological rehabilitation: a single-blind study. International Neurological Journal. 2019; (5): 5-11. https://doi.org/10.22141/2224-0713.5.107.2019.176700

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Motor skills; Activities of Daily living
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2019-08-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No