Intensive Neurorehabilitation for Cerebral Palsy (IntReh4CP)

International Clinic of Rehabilitation, Ukraine

Status: Completed

Conditions: Cerebral Palsy

Treatments: Procedure: Activity and care as usual; Procedure: Intensive Neurophysiological Rehabilitation System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04093180

2019-08-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups

Experimental group

Experimental group

Description:

Experimental group undergoing treatment course according to INRS

Treatment:

Procedure: Intensive Neurophysiological Rehabilitation System

Control group

Other group

Description:

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

Treatment:

Procedure: Activity and care as usual