Intensive Neurorehabilitation for Cerebral Palsy

Cerebral Palsy Clinical Trial

— IntReh4CP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093180
• Other study ID #: 2019-08-03
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2022
• Source: International Clinic of Rehabilitation, Ukraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Procedure:
• Intensive Neurophysiological Rehabilitation System
Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.
• Activity and care as usual
Control group continues usual activity and care while staying in the waiting list.

Locations

Country	Name	City	State
Ukraine	International Clinic of Rehabilitation	Truskavets	Lviv Region

Sponsors (4)

Lead Sponsor	Collaborator
International Clinic of Rehabilitation, Ukraine	Elita Rehabilitation Center, I.Horbachevsky Ternopil National Medical University, Rainbow Kids e.V.

Country where clinical trial is conducted

Ukraine, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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