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NCT07597746
"Effects of a Combined Repetitive Transcranial Magnetic Stimulation and Physical Therapy Protocol on Motor Function, Balance, and Quality of Life in Chronic Post-Stroke Hemiplegia: A Case Series"
Conditions: Chronic Stroke, Balance
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Sierra Varona SL
Summary
Chronic post-stroke hemiplegia frequently results in persistent motor deficits, impaired balance, and reduced quality of life. Conventional physical therapy is fundamental for functional recovery; however, motor improvement often plateaus during the chronic phase. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown potential to enhance motor recovery by modulating cortical excitability and promoting neuroplasticity.
This case series aims to investigate the effects of a combined protocol of repetitive transcranial magnetic stimulation and conventional physical therapy on motor function, balance, and quality of life in individuals with chronic post-stroke hemiplegia. Participants will undergo rTMS applied to the motor cortex in conjunction with a structured physical therapy program. Clinical outcomes will be assessed before and after the intervention to explore feasibility, safety, and potential functional benefits of the combined approach.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of first-ever unilateral ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI)
* Chronic post-stroke hemiplegia (≥ 6 months since stroke onset)
* Moderate to severe motor impairment of the affected lower limb (FMA-LE score between 10 and 28 points)
* Age between 18 and 75 years
* Medically stable and able to participate in a rehabilitation program
* Ability to understand study procedures and provide written informed consent
* No contraindications to repetitive transcranial magnetic stimulation (rTMS), according to current safety guidelines.
Exclusion Criteria:
* History of epilepsy or seizures
* Presence of pacemakers, cochlear implants, intracranial metallic implants, or other contraindications to rTMS
* Severe cognitive impairment or communication deficits preventing participation
* Progressive neurological disorders or unstable medical conditions
* Participation in other experimental neurorehabilitation interventions during the study period
* Any condition judged by investigators to compromise safety or data valid
Source: ClinicalTrials.gov (NCT07597746). StuddyBuddy aggregates publicly available trial information.