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Die klinische Studie NCT07488429 für Diplegische Zerebralparese mit Spastik, Cerebral Palsy, Spastic, Diplegic, Transcranial Magnetic Stimilation, Zerebralparese (CP) ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Kartenansicht

Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy 20 Nicht-invasiv International Pädiatrisch Bewegung

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Die klinische Studie NCT07488429 ist eine interventionsstudie zur Untersuchung von Diplegische Zerebralparese mit Spastik, Cerebral Palsy, Spastic, Diplegic, Transcranial Magnetic Stimilation, Zerebralparese (CP) und hat den Status offene rekrutierung. Die Studie startete am 5. Mai 2025 und soll 20 Teilnehmer aufnehmen. Durchgeführt von Ankara City Hospital Bilkent ist der Abschluss für 30. September 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 23. März 2026 aktualisiert.
Kurzbeschreibung
Cerebral palsy (CP) is widely recognized as the most prevalent cause of lifelong physical disability emerging in childhood across most global populations. While international data typically reports a prevalence ranging from 1.5 to 2.5 per 1,000 live births, in our specific national context, this rate is notably higher, reaching 4.4 per 1,000. CP is defined as a heterogeneous group of permanent disorders that fundamen...Mehr anzeigen
Ausführliche Beschreibung
1. Aim and Significance of the Research Cerebral palsy (CP) is the most common cause of lifelong physical disability observed in childhood in most countries, with a prevalence ranging from 1.5 to 2.5 per 1,000 live births (1); in our country, this rate is 4.4.

CP is a group of permanent disorders affecting the development of movement and posture, leading to activity limitation, attributed to non-progressive disturb...

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Offizieller Titel

Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy

Erkrankungen
Diplegische Zerebralparese mit SpastikCerebral Palsy, Spastic, DiplegicTranscranial Magnetic StimilationZerebralparese (CP)
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • E2-25-10341
NCT-Nummer
Studienbeginn (tatsächlich)
2025-05-05
Zuletzt aktualisiert
2026-03-23
Studienende (vorauss.)
2026-09-30
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellrTMS + Comprehensive Neurological Rehabilitation
Participants receive 20 sessions of 5 Hz rTMS (1,500 pulses/session, 5 days/week for 4 weeks) followed by a daily neurological rehabilitation program (45 min physiotherapy, twice-weekly OT, thrice-weekly child development sessions, and 10 sessions of robotic gait training)
TMS
The objective of TMS is to stimulate neurons in targeted regions and their associated neuronal networks through an intact skull using a coil. This stimulation modulates the neuronal activity pattern in the targeted cortical area: it achieves this by providing an inhibitory effect when used at low frequencies (1-5 Hz) or an excitatory effect when used at high frequencies (5-20 Hz), thereby restoring neuronal balance i...Mehr anzeigen
Keine InterventionComprehensive Neurological Rehabilitation Alone
Participants receive the daily neurological rehabilitation program alone (45 min physiotherapy, twice-weekly OT, thrice-weekly child development sessions, and 10 sessions of robotic gait training) without rTMS
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Gross Motor Function Measure-88 (GMFM-88) - Dimension D and E
This is a widely used classification system in CP-related research. It is a valid and reliable scale for classifying the severity of gross motor function limitations in children with CP. It defines the major functional characteristics of children with CP by dividing them into four age groups: under 2 years, 2-4 years, 4-6 years, and 6-12 years. Children at Level I are the most independent in motor functions, while children at Level V are the most dependent.
Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is used to assess the severity of spasticity. The joint is moved passively through its range of motion, and the perceived resistance is evaluated. (MAS 0: No increase in muscle tone; 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion; 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout less than half of the remainder of the range of motion; 2. More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved; 3. Considerable increase in muscle tone, passive movement difficult; 4. Affected part(s) rigid in flexion or extension).
Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Timed Up and Go (TUG) Test
he Timed Up and Go (TUG) test is a practical and reliable tool used to assess functional mobility, dynamic balance, and transfer skills in children. It is a sensitive measure for monitoring changes in gross motor function, particularly in children with CP.
Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.
Functional Mobility Scale (FMS)
The FMS is an assessment system designed to measure changes in walking ability that can be observed following interventions. The FMS classifies children's performance across three distances (5, 50, and 500 meters) based on their need for a wheelchair or assistive devices. Unlike the GMFCS, significant changes in FMS levels are observed following orthopedic surgery or other clinical interventions.
Patients included in the study will be evaluated at baseline (pre-treatment), immediately after the intervention (post-treatment), and at a 12-week follow-up from the start of treatment.
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
5 Years
Zugelassene Geschlechter
Alle

Between 5 and 18 years of age. Cooperative and oriented (capable of following commands). Gross Motor Function Classification System (GMFCS) Level II or III. Diagnosis of Spastic Diplegic Cerebral Palsy.

Poor general health status.

Children with severe comorbid conditions (e.g., total or partial blindness, severe lower extremity deformities, etc.).

Diagnosis of epilepsy.

History of seizures.

Presence of a cardiac pacemaker.

Presence of metal implants (specifically in the cranial and cervical regions).

Open wounds or infections at the application site.

History of botulinum toxin injection or surgical intervention within the 6 months prior to study enrollment.

History of Selective Posterior Rhizotomy (SPR) surgery.

Ankara City Hospital Bilkent logoAnkara City Hospital Bilkent
Verantwortliche Partei
Özlem Kaynar Şişman, Hauptprüfer, assistant doctor, Ankara City Hospital Bilkent
Zentrale Studienkontakte
Kontakt: özlem kaynar şişman, +90 5418479210, [email protected]
1 Studienstandorte in 1 Ländern
Ankara Bilkent City Hospital, Ankara, Turkey (Türkiye)
ÖZLEM KAYNAR ŞİŞMAN, Kontakt, +90 5418479210, [email protected]
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