Intensive Neurorehabilitation for Cerebral Palsy (IntReh4CP)
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| ClinicalTrials.gov Identifier: NCT04093180 |
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Recruitment Status :
Completed
First Posted : September 17, 2019
Last Update Posted : June 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Procedure: Intensive Neurophysiological Rehabilitation System Procedure: Activity and care as usual | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Intensive Neurophysiological Rehabilitation System in Children With Cerebral Palsy: Randomized Controlled Trial |
| Actual Study Start Date : | September 25, 2019 |
| Actual Primary Completion Date : | April 30, 2022 |
| Actual Study Completion Date : | April 30, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental group
Experimental group undergoing treatment course according to INRS
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Procedure: Intensive Neurophysiological Rehabilitation System
Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities. |
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Control group
Wait-list delayed intervention. Control group continues usual activity and care while staying in the waiting list.
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Procedure: Activity and care as usual
Control group continues usual activity and care while staying in the waiting list. |
- 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.
- 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.
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| Ages Eligible for Study: | 4 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093180
| Ukraine | |
| International Clinic of Rehabilitation | |
| Truskavets, Lviv Region, Ukraine, 82200 | |
| Principal Investigator: | Oleh Kachmar, MD, PhD | International Clinic of Rehabilitation, Ukraine |
| Responsible Party: | Oleh Kachmar, Head of Innovative Techologies department, International Clinic of Rehabilitation, Ukraine |
| ClinicalTrials.gov Identifier: | NCT04093180 |
| Other Study ID Numbers: |
2019-08-03 |
| First Posted: | September 17, 2019 Key Record Dates |
| Last Update Posted: | June 21, 2022 |
| Last Verified: | June 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Rehabilitation Motor skills Activities of Daily living |
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Cerebral Palsy Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |