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Evaluation of effects of differents montages of non invasive brain eletrical stimulation in funcionality of children with cerebral palsy of type spastic hemiparesis

Effects of differents montages of tDCS in functionality of children with Cerebral Palsy of type Spastic Hemiparesis: clinical trial randomized, placebo-controlled and double blind

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-95xwc7
Enrollment
Unknown
Registered
2015-07-27
Start date
2015-11-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy. Hemiparesis.

Interventions

Group 1: anodal tDCS on motor cortex primary and cathode in the contralateral supraorbital region associated to gait training on a treadmill
Group 2: placebo tDCS anode on the primary motor cortex and cathode in the contralateral supraorbital region associated to gait training on a treadmill
Group3: anodal tDCS on the primary motor cortex of the injured hemisphere and cathodic stimulation in the contralateral primary motor cortex associated with gait training on a treadmill. Participants
Behavioural

Sponsors

Universidade Nove de Julho
Lead Sponsor
Universidade Nove de Julho
Collaborator

Eligibility

Age
6 Years to 10 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria will be thirty children who: a) have the diagnosis of CP spastic hemiparesis; functionally classified as levels I and II by GMFCS (Palisano et al, 1997;. Hiratuka et al, 2010).; have independent walking at least 12 months; the age group of six and ten years of life; have degrees of understanding and consistent collaboration with the completion of the proposed activities; The parents agree with their participation in the study by signing the Informed Consent

Exclusion criteria

Exclusion criteria: Children who will be excluded have undergone surgical procedures or neurolytic blocks in the last 12 months before the start of the training sessions; presenting structured orthopedic deformities with surgical indications; have epilepsy; having metal implant in the brain or hearing aids.

Design outcomes

Primary

MeasureTime frame
We believe that the group with de bilateral montage has better results when compared with unilateral montage. Perform a comparative analysis between the effects of different montages of transcranial direct current stimulation associated with gait training on the treadmill on functional mobility, gait pattern (spatiotemporal, kinematic and kinetic gait parameters), static equilibrium and functional performance in children with spastic hemiparetic cerebral palsy, after 10 sessions of treadmill training simultaneously the use of tDCS (2 weeks consecutively - 5 sessions per week). The evaluations will be performed before de intervention, after and one month after the end of the sessions of intervention The sample size calculation was performed using the statistical software STATA 11, based on the research Grecco et al. (2013) "A comparison of treadmill training and overground walking in ambulant children with cerebral palsy: randomized controlled clinical trial." For Calculated based gait speed. Gait velocity was considered to represent an important clinical outcome and directly related to the intervention. The study Grecco et al. was selected by engaging a similar population to which this project aims to engage (children with CP levels I - III of the GMFCS). Based on the average of the experimental group of 1.0 m / s, with standard deviation of 0,22m / s of 0,71m / s control group, with standard deviation of 0.12 M / s, for a bidirectional alpha 0.05 and a power of 80% will be required 8 children per group. The sample is increased by 20% in order to avoid the effects of possible losses ending with a number of 10 children in each group, a total of 30 participants.

Secondary

MeasureTime frame
Verify proper montage of tDCS performed during gait training on a treadmill, to optimize the function of gait, static balance and functional performance of children with cerebral palsy spastic hemiparesis, after 10 sessions of treadmill training simultaneously the use of tDCS (2 weeks consecutively - 5 sessions per week). The evaluations will be performed before de intervention, after and one month after the end of the sessions of intervention

Countries

Brazil

Contacts

Public ContactNatália Duarte

Universidade Nove de Julho

natycarvalho_fisio@hotmail.com55(35)36659335

Outcome results

None listed

Source: REBEC (via WHO ICTRP)