Cerebral palsy describes a group of permanent disorders of the development of movement and posture, causing activity limitation that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain.
Nowadays, CP is not fully curable, and physiotherapy should be used in conjunction with other interventions such as oral drugs, botulinum toxin type A, continuous pump-administered intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy. However, several systematic reviews conclude that there is low evidence that these invasive therapies are more effective than placebo.
Repetitive transcranial magnetic stimulation (rTMS) is a type of neuromodulatory technique through magnetic impulses. The effect of rTMS depends on the frequency of the emitted electromagnetic field; low frequencies (≤1 Hz) lead to an inhibition of neuronal electrical activity at the stimulation site, while high frequencies (≥3 Hz) cause neuronal depolarization.
The objective of the project is to evaluate the effectiveness of a repetitive Transcranial Magnetic Stimulation (rTMS) protocol, as an adjunct treatment to neurorehabilitation to improve gross motor function and quality of life in school-age children with spastic diplegia-type infantile cerebral palsy.
Primary school children with diagnose of Spastic Diplegia CP
> 1 on Mas in hip flexors, adductors and tibialis anterior of both lower extremities.
Parents/legal guardians signed the Informed consent
Severe mental retardation
Present epilepsy
Present any remedial surgery/medication
Less than 1 year post orthopaedic surgery
Crossover
repetitive Transcranial Magnetic Stimulation
DeviceTo apply the rTMS will be used the device Neuro-MS/D Variant-3 therapeutic advanced (Neurosoft, Russia) with double cone shape coil. The coil will be placed at Cz according to 10-20 system. The rTMS protocol will be: Train frequency - 10 Hz Train duration - 10 sec Inter train interval - 50 seconds Number of train - 25 \------------------------------------- Total pulses - 2500 Total session duration - 1500 seconds
sham repetitive Transcranial Magnetic Stimulation
DeviceNeuro-MS/D magnetic stimulator (Neurosoft, Russia) with Neuro-MS.NET software will be used. The synchronous sound will be performed using monitor speaker connected to magnetic stimulator via trigger unit and located near discharging coil. The 10-Hz electrical stimulation will be given trough electrodes fixed on the head along the front edge of the coil to mimic the sensation
Change in Gross Motor Function by the Gross Motor Function-66
The GMFM is a standardized assessment instrument designed to measure change over time in gross motor function in cerebral palsy children. The GMFS-66 is an 66-item measure with five dimensions: lying and rolling, crawling/kneeling, standing and walking/running/jumping. Each GMFM item is graded on a 4-point scale. The magnitude of change that is considered clinically important for an individual child will vary and depend on the judgments made by the child, family, and therapist. It takes between 20-25 minutes to be completed. GMFM presents good longitudinal construct validity, the test - retest is high with a 0.99 ICC and researchers indicate that GMFM adequately measure change over time in gross motor function for children with CP.
Change in Functional Strength by the Functional Strength Measure
The functional strength measurement (FSM) measures functional strength in both, upper and lower extremities. It consists of eight items matching activities of children in aged group from 4 to 10 years with typically developing (TD). The FSM has been adapted for children with CP (FSM-CP). The test-retest reliability of FSM-CP, has shown to be high and the comparison of the scores on the FSM-CP with the HHD showed mostly moderate correlations. In the present study, only the items related to lower extremities will be evaluated. Participants will have the opportunity to practice every test item maximum five trials before being tested. Each item will be examined three times and the highest score will be the useful for the analysis. To be able to say that a child improved after a treatment, needs to improve his/her score from the last examination.
Change in Quality of Life by the Cerebral Palsy Quality of Life-Child
The CP QOL-Child is questionnaire designed to assess the QOL in children aged between 4-12 years. It is composed by two parts. The first one a caregiver/parent report for children aged 4 to 12 years and the second one is a self-report of children aged from 9 to 12 years. The parent-proxy version comprises 65 items, and the child self-report version comprises 53 items. The CP QOL-Child measures the seven areas of child's life such as; social wellbeing and acceptance, participation and physical health, feelings about functioning, emotional wellbeing and self-esteem, pain and impact of disability, access to services, and family health. For each question there's a number 1 (very unhappy) to 9 (very happy) (46). The scoring involves two steps. At the first step the items are transformed to a scale with a possible range of 0-100 and the second step it is done by the algebraic mean of item values for each domain. The scoring process is explained on the CP QOL-Child manual 2nd version.
Change in Spasticity by the Modified-Modified Ashworth Scale.
The scale most commonly used to evaluate spasticity is the Ashworth scale (AS) and the Modified Ashworth Scale (MAS). The ICC scores of interrater reliability ranged from 0.54 to 0.80 and the intrarater reliability from 0.31 to 0.82. MAS is the primary outcome measure but at the time of data analysis the grades are modified (m-MAS), Modified-Modified Ashworth Scale. Therefore, the Rehabilitation Measures Database, suggests that a one-point change on the MAS reflects a clinically significant improvement. The score is based on the resistance felt during that one second of passive movement and it should be done 1-3 times at most. The target muscles will be hip flexors, adductors and tibialis anterior in both lower extremities. Physiotherapists will be experienced in applying MAS.
Change in Impact on family by the Revised Impact on Family questionnaire
The RIOF scale was designed specifically to measure the impact of paediatric chronic illness on the family. It consists of 15 items with good psychometric properties. Each item represents a statement about having a chronically ill or disabled child. Parents/legal guardians are asked to rate on a four-level scale (strongly disagree or strongly agree) to which degree each of the items applies to the current situation of the family. The instrument is also reliable and valid to be implemented with chronic hospitalized children.
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