Cerebral Palsy
Conditions
Keywords
Rehabilitation, Motor skills, Activities of Daily living
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.
Interventions
PROCEDUREIntensive Neurophysiological Rehabilitation System
Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.
PROCEDUREActivity and care as usual
Control group continues usual activity and care while staying in the waiting list.
Sponsors
I.Horbachevsky Ternopil National Medical University
Elita Rehabilitation Center
Rainbow Kids e.V.
International Clinic of Rehabilitation, Ukraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gross Motor Function Measure score (GMFM-66) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Daily functioning- Self-Care | 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 | 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 Manual dexterity | 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 ABILHAND-Kids score | 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 | Baseline, 3-week, and 7-week follow-up | Range of motion is measured with a hand-held goniometer. |
| Change in Jebsen-Taylor hand function score | 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. |
Countries
Ukraine
Outcome results
None listed