Intensive Neurorehabilitation for Cerebral Palsy

NCT ID: NCT04093180

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2022-04-30

Brief Summary

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

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

Experimental group undergoing treatment course according to INRS

Group Type: EXPERIMENTAL

Intensive Neurophysiological Rehabilitation System

Intervention Type: PROCEDURE

Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.

Control group

Wait-list delayed intervention. Control group continues usual activity and care while staying in the waiting list.

Group Type: OTHER

Activity and care as usual

Intervention Type: PROCEDURE

Control group continues usual activity and care while staying in the waiting list.

Interventions

Intensive Neurophysiological Rehabilitation System

Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.

Intervention Type: PROCEDURE

Activity and care as usual

Control group continues usual activity and care while staying in the waiting list.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.Horbachevsky Ternopil National Medical University

OTHER

Sponsor Role: collaborator

Elita Rehabilitation Center

INDUSTRY

Sponsor Role: collaborator

Rainbow Kids e.V.

UNKNOWN

Sponsor Role: collaborator

International Clinic of Rehabilitation, Ukraine

OTHER

Sponsor Role: lead

Responsible Party

Oleh Kachmar

Head of Innovative Techologies department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oleh Kachmar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

International Clinic of Rehabilitation, Ukraine

Locations

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, Ukraine

Countries

Ukraine

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Kushnir A, Kachmar O. Intensive Neurophysiological Rehabilitation System for children with cerebral palsy: a quasi-randomized controlled trial. BMC Neurol. 2023 Apr 20;23(1):157. doi: 10.1186/s12883-023-03216-4.

Reference Type: DERIVED

PMID: 37081406 (View on PubMed)

Other Identifiers

2019-08-03

Identifier Type: -

Identifier Source: org_study_id