Intensive Neurorehabilitation for Cerebral Palsy (IntReh4CP)

• ClinicalTrials.gov Identifier: NCT04093180
• Recruitment Status: Completed
• First Posted: September 17, 2019
• Last Update Posted: June 21, 2022
• Sponsor: International Clinic of Rehabilitation, Ukraine
• Collaborators: I.Horbachevsky Ternopil National Medical University; Elita Rehabilitation Center; Rainbow Kids e.V.
• Information provided by (Responsible Party): Oleh Kachmar, International Clinic of Rehabilitation, Ukraine

Tracking Information

• First Submitted Date: September 16, 2019
• First Posted Date: September 17, 2019
• Last Update Posted Date: June 21, 2022
• Actual Study Start Date: September 25, 2019
• Actual Primary Completion Date: April 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2019)

Change in Gross Motor Function Measure score (GMFM-66) [ Time Frame: Baseline, 3-week, and 7-week follow-up ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 16, 2019)

• Change in Manual dexterity [ Time Frame: Baseline, 3-week, and 7-week follow-up ]
  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.
• Change in Daily functioning- Self-Care [ Time Frame: Baseline, 3-week, and 7-week follow-up ]
  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.
• Change in Daily functioning- Mobility [ Time Frame: Baseline, 3-week, and 7-week follow-up ]
  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.
• Change in Jebsen-Taylor hand function score [ Time Frame: Baseline, 3-week, and 7-week follow-up ]
  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.
• Change in ABILHAND-Kids score [ Time Frame: Baseline, 3-week, and 7-week follow-up ]
  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).
• Change in passive range of ankle dorsiflexion [ Time Frame: Baseline, 3-week, and 7-week follow-up ]
  Range of motion is measured with a hand-held goniometer.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intensive Neurorehabilitation for Cerebral Palsy
• Official Title: Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cerebral Palsy

Intervention

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

Study Arms

• Experimental: Experimental group
  Experimental group undergoing treatment course according to INRS
  Intervention: Procedure: Intensive Neurophysiological Rehabilitation System
• Control group
  Wait-list delayed intervention. Control group continues usual activity and care while staying in the waiting list.
  Intervention: Procedure: Activity and care as usual

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2022): 43
• Original Estimated Enrollment (submitted: September 16, 2019): 45
• Actual Study Completion Date: April 30, 2022
• Actual Primary Completion Date: April 30, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ukraine

Administrative Information

• NCT Number: NCT04093180
• Other Study ID Numbers: 2019-08-03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Oleh Kachmar, International Clinic of Rehabilitation, Ukraine
• Original Responsible Party: Same as current
• Current Study Sponsor: International Clinic of Rehabilitation, Ukraine
• Original Study Sponsor: Same as current

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

• PRS Account: International Clinic of Rehabilitation, Ukraine
• Verification Date: June 2022