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Intensive Neurorehabilitation for Cerebral Palsy (IntReh4CP)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Intensive Neurophysiological Rehabilitation System
Activity and care as usual
Sponsored by
International Clinic of Rehabilitation, Ukraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Rehabilitation, Motor skills, Activities of Daily living

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • International Clinic of Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

Experimental group undergoing treatment course according to INRS

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
Change in passive range of ankle dorsiflexion
Range of motion is measured with a hand-held goniometer.

Full Information

First Posted
September 16, 2019
Last Updated
June 17, 2022
Sponsor
International Clinic of Rehabilitation, Ukraine
Collaborators
I.Horbachevsky Ternopil National Medical University, Elita Rehabilitation Center, Rainbow Kids e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04093180
Brief Title
Intensive Neurorehabilitation for Cerebral Palsy
Acronym
IntReh4CP
Official Title
Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Clinic of Rehabilitation, Ukraine
Collaborators
I.Horbachevsky Ternopil National Medical University, Elita Rehabilitation Center, Rainbow Kids e.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Rehabilitation, Motor skills, Activities of Daily living

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group undergoing treatment course according to INRS
Arm Title
Control group
Arm Type
Other
Arm Description
Wait-list delayed intervention. Control group continues usual activity and care while staying in the waiting list.
Intervention Type
Procedure
Intervention Name(s)
Intensive Neurophysiological Rehabilitation System
Intervention Description
Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.
Intervention Type
Procedure
Intervention Name(s)
Activity and care as usual
Intervention Description
Control group continues usual activity and care while staying in the waiting list.
Primary Outcome Measure Information:
Title
Change in Gross Motor Function Measure score (GMFM-66)
Description
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.
Time Frame
Baseline, 3-week, and 7-week follow-up
Secondary Outcome Measure Information:
Title
Change in Manual dexterity
Description
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.
Time Frame
Baseline, 3-week, and 7-week follow-up
Title
Change in Daily functioning- Self-Care
Description
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.
Time Frame
Baseline, 3-week, and 7-week follow-up
Title
Change in Daily functioning- Mobility
Description
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.
Time Frame
Baseline, 3-week, and 7-week follow-up
Title
Change in Jebsen-Taylor hand function score
Description
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.
Time Frame
Baseline, 3-week, and 7-week follow-up
Title
Change in ABILHAND-Kids score
Description
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).
Time Frame
Baseline, 3-week, and 7-week follow-up
Title
Change in passive range of ankle dorsiflexion
Description
Range of motion is measured with a hand-held goniometer.
Time Frame
Baseline, 3-week, and 7-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleh Kachmar, MD, PhD
Organizational Affiliation
International Clinic of Rehabilitation, Ukraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Clinic of Rehabilitation
City
Truskavets
State/Province
Lviv Region
ZIP/Postal Code
82200
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
background
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
Results Reference
background

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Intensive Neurorehabilitation for Cerebral Palsy

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