NCT04093180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

2.6 years

First QC Date

September 16, 2019

Last Update Submit

June 17, 2022

Conditions

Cerebral Palsy

Keywords

RehabilitationMotor skillsActivities of Daily living

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Manual dexterity

    Baseline, 3-week, and 7-week follow-up

  • Change in Daily functioning- Self-Care

    Baseline, 3-week, and 7-week follow-up

  • Change in Daily functioning- Mobility

    Baseline, 3-week, and 7-week follow-up

  • Change in Jebsen-Taylor hand function score

    Baseline, 3-week, and 7-week follow-up

  • Change in ABILHAND-Kids score

    Baseline, 3-week, and 7-week follow-up

  • +1 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group undergoing treatment course according to INRS

Procedure: Intensive Neurophysiological Rehabilitation System

Control group

OTHER

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

Procedure: Activity and care as usual

Interventions

Intensive Neurophysiological Rehabilitation SystemPROCEDURE

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

Experimental group
Activity and care as usualPROCEDURE

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

Control group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Cerebral Palsy bilateral spastic forms,
  • Age 4-12 years,
  • Gross Motor Function Classification System - Levels I-IV,
  • Manual Ability Classification System - Levels I-IV.

You may not qualify if:

  • Uncontrolled epileptic syndrome,
  • Severe intellectual disability,
  • Uncooperative behavior,
  • Surgery during ongoing year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Clinic of Rehabilitation

Truskavets, Lviv Oblast, 82200, Ukraine

Location

Related Publications (3)

  • 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

    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

    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.

    PMID: 37081406DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Oleh Kachmar, MD, PhD

    International Clinic of Rehabilitation, Ukraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Innovative Techologies department

Study Record Dates

First Submitted

September 16, 2019

First Posted

September 17, 2019

Study Start

September 25, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)