Clinical trial NCT04093180: Intensive Neurorehabilitation for Cerebral Palsy
Official title: Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Rehabilitation
Motor skills
Activities of Daily living
Lead sponsor: International Clinic of Rehabilitation, Ukraine
Sponsor class: OTHER
Collaborators: name: I.Horbachevsky Ternopil National Medical University
name: Elita Rehabilitation Center
name: Rainbow Kids e.V.
First posted: 2019-09-17
Enrollment: 43
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Gross Motor Function Measure score (GMFM-66)
timeFrame: Baseline, 3-week, and 7-week follow-up
Secondary outcomes:
measure: Change in Manual dexterity
timeFrame: Baseline, 3-week, and 7-week follow-up
measure: Change in Daily functioning- Self-Care
timeFrame: Baseline, 3-week, and 7-week follow-up
measure: Change in Daily functioning- Mobility
timeFrame: Baseline, 3-week, and 7-week follow-up
measure: Change in Jebsen-Taylor hand function score
timeFrame: Baseline, 3-week, and 7-week follow-up
measure: Change in ABILHAND-Kids score
timeFrame: Baseline, 3-week, and 7-week follow-up
measure: Change in passive range of ankle dorsiflexion
timeFrame: Baseline, 3-week, and 7-week follow-up
Other outcomes:
Locations:
city: Truskavets
country: Ukraine
facility: International Clinic of Rehabilitation
state: Lviv Region
Study officials:
affiliation: International Clinic of Rehabilitation, Ukraine
name: Oleh Kachmar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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