Cerebral PalsyIntReh4CPNCT04093180
Intensive Neurorehabilitation for Cerebral Palsy
A study testing Intensive Neurophysiological Rehabilitation System and Activity and care as usual in people with Cerebral Palsy, run by International Clinic of Rehabilitation, Ukraine at 1 site in Ukraine.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intensive Neurophysiological Rehabilitation System and Activity and care as usual
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUkraine
- Study dates
- 25 Sep 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral Palsy bilateral spastic forms,
- Age 4-12 years,
- Gross Motor Function Classification System - Levels I-IV,
- Manual Ability Classification System - Levels I-IV.
Who cannot join
- Uncontrolled epileptic syndrome,
- Severe intellectual disability,
- Uncooperative behavior,
- Surgery during ongoing year.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
International Clinic of Rehabilitation
Truskavets, Lviv Oblast, 82200
About this study
Official title: Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial
Evaluation of effects of Intensive Neurophysiological Rehabilitation System in children with cerebral palsy in a single-blinded randomized controlled trial with two groups.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Intensive Neurophysiological Rehabilitation System, Activity and care as usual
- Keywords
- Rehabilitation, Motor skills, Activities of Daily living
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Neurophysiological Rehabilitation SystemProcedure or surgery
Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.
Activity and care as usualProcedure or surgery
Control group continues usual activity and care while staying in the waiting list.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group undergoing treatment course according to INRS Receives: 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. Receives: Procedure: Activity and care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3-week, and 7-week follow-up
Secondary outcomes (6)
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.
Measured: Baseline, 3-week, and 7-week follow-up
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.
Measured: Baseline, 3-week, and 7-week follow-up
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.
Measured: Baseline, 3-week, and 7-week follow-up
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.
Measured: Baseline, 3-week, and 7-week follow-up
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).
Measured: Baseline, 3-week, and 7-week follow-up
Change in passive range of ankle dorsiflexion
Range of motion is measured with a hand-held goniometer.
Measured: Baseline, 3-week, and 7-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start25 Sep 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Clinic of Rehabilitation, Ukraine
- Sponsor type
- University, hospital or other
- Collaborators
- I.Horbachevsky Ternopil National Medical University, Elita Rehabilitation Center, Rainbow Kids e.V.
- Responsible party
- Principal investigator, Oleh Kachmar, International Clinic of Rehabilitation, Ukraine
- Investigators
- Oleh Kachmar, MD, PhD, Principal investigator, International Clinic of Rehabilitation, Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093180
- Sponsor's protocol ID
- 2019-08-03
- Acronym
- IntReh4CP
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2019
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
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.
PubMed 37081406
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04093180
- Acronym / sponsor ID
- IntReh4CP / 2019-08-03
- Conditions
- Cerebral Palsy
- Keywords
- Rehabilitation, Motor skills, Activities of Daily living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- International Clinic of Rehabilitation, UkraineUniversity, hospital or other
- Collaborators
- I.Horbachevsky Ternopil National Medical University, Elita Rehabilitation Center, Rainbow Kids e.V.
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Intensive Neurophysiological Rehabilitation SystemExperimental group undergoing treatment course according to INRS |
| Control group | Other | Procedure: Activity and care as usualWait-list delayed intervention. Control group continues usual activity and care while staying in the waiting list. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cerebral Palsy bilateral spastic forms,
- Age 4-12 years,
- Gross Motor Function Classification System - Levels I-IV,
- Manual Ability Classification System - Levels I-IV.
Key exclusion criteria (4 listed)
- Uncontrolled epileptic syndrome,
- Severe intellectual disability,
- Uncooperative behavior,
- Surgery during ongoing year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Neurophysiological Rehabilitation SystemIntensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities. | Procedure or surgery | Experimental group |
| Activity and care as usualControl group continues usual activity and care while staying in the waiting list. | Procedure or surgery | Control group |
Primary outcome
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.
6 secondary outcomes
Change in Manual dexterity
Time frame: Baseline, 3-week, and 7-week follow-up
Change in Daily functioning- Self-Care
Time frame: Baseline, 3-week, and 7-week follow-up
Change in Daily functioning- Mobility
Time frame: Baseline, 3-week, and 7-week follow-up
Change in Jebsen-Taylor hand function score
Time frame: Baseline, 3-week, and 7-week follow-up
Change in ABILHAND-Kids score
Time frame: Baseline, 3-week, and 7-week follow-up
Change in passive range of ankle dorsiflexion
Time frame: Baseline, 3-week, and 7-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- BackgroundKachmar, 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
- BackgroundKachmar, 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
- Derived from this study: PubMed 37081406Kushnir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleh Kachmar, MD, PhD principal investigator
International Clinic of Rehabilitation, Ukraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Neurophysiological Rehabilitation System and Activity and care as usual in people with Cerebral Palsy, run by International Clinic of Rehabilitation, Ukraine at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Function Measure score (GMFM-66) (time frame: Baseline, 3-week, and 7-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093180, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.