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Clinical Trial NCT07488429 for Diplegic Cerebral Palsy With Spasticity, Cerebral Palsy, Spastic, Diplegic, Transcranial Magnetic Stimilation, Cerebral Palsy (CP) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy 20 Non-Invasive International Pediatric Exercise-Based
Clinical Trial NCT07488429 is an interventional study for Diplegic Cerebral Palsy With Spasticity, Cerebral Palsy, Spastic, Diplegic, Transcranial Magnetic Stimilation, Cerebral Palsy (CP) that is recruiting. It started on 5 May 2025 with plans to enroll 20 participants. Led by Ankara City Hospital Bilkent, it is expected to complete by 30 September 2026. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
Brief Summary
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...Show More
Detailed Description
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...
Show MoreOfficial Title
Impact of rTMS Combined With Neurorehabilitation on Lower Extremity Motor Function and Spasticity in Children With Spastic Diplegic Cerebral Palsy
Conditions
Diplegic Cerebral Palsy With SpasticityCerebral Palsy, Spastic, DiplegicTranscranial Magnetic StimilationCerebral Palsy (CP)Publications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- E2-25-10341
NCT ID Number
Start Date (Actual)
2025-05-05
Last Update Posted
2026-03-23
Completion Date (Estimated)
2026-09-30
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalrTMS + 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...Show More |
No 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 | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
5 Years
Eligible Sexes
All
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 BilkentStudy Responsible Party
Özlem Kaynar Şişman, Principal Investigator, assistant doctor, Ankara City Hospital Bilkent
Study Central Contact
Contact: özlem kaynar şişman, +90 5418479210, [email protected]
1 Study Locations in 1 Countries
Ankara Bilkent City Hospital, Ankara, Turkey (Türkiye)
ÖZLEM KAYNAR ŞİŞMAN, Contact, +90 5418479210, [email protected]
Recruiting