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rTMS and Treadmill Training in children with Spastic Cerebral Palsy

Neuromodulation of the primary motor cortex by rTMS and Treadmill Training in children with Spastic Serebral Palsy: a randomized, double-blinded, controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2dsmhsq
Enrollment
Unknown
Registered
2025-01-22
Start date
2024-12-02
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

Interventions

Sponsors

Universidade Evangélica de Goiás
Lead Sponsor
Follow Kids - Clinica de Neuro Reabilitação Infantil
Collaborator

Eligibility

Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Diagnosis of spastic cerebral palsy; functional classification on Levels I, II or III of the Gross Motor Function Classification System (GMFCS); ability to walk independently in at least the previous 12 months, even if requiring a gait-assistance device; age between six and 12 years; degree of understanding and cooperation compatible with the execution of the proposed activities; statement of informed consent signed by a legal guardian and statement of informed assent signed by the participant

Exclusion criteria

Exclusion criteria: Children that having been submitted to surgical procedures or neurolytic block in the 12 months prior to the onset of the training sessions; orthopedic deformities with indication for surgery; epilepsy; metal implants in skull or hearing aids; intellectual disorder that would limit the execution of the intellectual activities proposed in the study

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in functional mobility, assessed by the timed up and go test (seconds), demonstrated by a reduction of 3 seconds in the test after the interventions. Data collected one week before the intervention and one and four weeks after the intervention ;It is expected to find an increase in the spatial and temporal parameters of gait, assessed by the walking test (m/s), demonstrated by the increase in gait speed after the interventions. Data collected one week before the intervention and one and four weeks after the intervention ;It is expected to find an improvement in gross motor function, assessed by the Gross Motor Function Measure – 88, demonstrated with a 5% increase in the score after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an improvement in functional balance, assessed by the Pediatric Balance Scale (points), demonstrated with an increase of 10 points on the scale after the interventions. Data collected one week before the intervention and one and four weeks after the intervention;It is expected to find an increase in participation, assessed by the Participation and Environment Measure for Children and Youth demonstrated by a 5% increase in scores after the interventions. Data collected one week before the intervention and one and four weeks after the intervention ;It is expected to find an increase in motor evoked potential amplitude only after the intervention with active repetitive transcranial magnetic stimulation. Motor evoked potential amplitude (microvolts) assessed by transcranial magnetic stimulation synchronized with the electromyograph. Data collected one week before the intervention and one and four weeks after the intervention

Secondary

MeasureTime frame
It is expected that no moderate or severe adverse effects will be found during the intervention period, as assessed by a standardized questionnaire that quantifies the perception and intensity of symptoms, demonstrated by the non-reporting of such effects. Data collected before and after each intervention session

Countries

Brazil

Contacts

Public ContactLuanda Collange

Universidade Evangélica de Goiás

luandacollange@hotmail.com+55 (62) 3310-6737

Outcome results

None listed

Source: REBEC (via WHO ICTRP)