About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
rTMS
DeviceRepetitive transcranial magnetic stimulation (rTMS) was delivered using low-frequency stimulation applied over the primary motor cortex. Stimulation parameters were individually adjusted based on the resting motor threshold and kept constant across sessions. Coil positioning and stimulation conditions were standardized to ensure reproducibility. Safety screening was conducted prior to stimulation sessions, and adverse events were monitored throughout the intervention period in accordance with established safety guidelines.
physical therapy
Other interventionThe physical therapy intervention consisted of a structured, task-oriented rehabilitation approach targeting motor control, balance, and functional mobility. Exercises were selected to promote activation of the affected limb, postural control, and functional movement patterns. The intervention followed standardized neurorehabilitation principles, with progressive adaptation of tasks based on individual performance and tolerance.
Treatment groups
Trial outcomes
Primary outcomes
Motor function (FMA)
Motor function was assessed using the Fugl-Meyer Assessment (FMA) for the affected upper and lower limbs. The FMA is a validated and reliable scale for evaluating motor impairment after stroke, with higher scores indicating better motor performance. The FMA has a total score ranging from 0 to 226 points (upper extremity: 0-66; lower extremity: 0-34; with additional domains contributing to the total score), with higher scores indicating better motor function. Changes in FMA scores were used to describe changes in motor function following the combined rTMS and physical therapy intervention.
balance
Balance was assessed using the Berg Balance Scale (BBS), a validated clinical tool designed to evaluate static and dynamic balance performance in individuals after stroke. The BBS consists of 14 functional tasks commonly affected in post-stroke hemiplegia. The BBS has a total score ranging from 0 to 56 points, with higher scores indicating better balance ability. Changes in BBS scores were used to describe balance improvements following the combined rTMS and physical therapy interventio
Functional mobility
Functional mobility was assessed using the Timed Up and Go (TUG) test. The TUG evaluates the ability to stand up from a seated position, walk, turn, and sit down, reflecting functional mobility and dynamic balance in individuals with post-stroke hemiplegia. Lower completion times indicate better functional performance. Changes in TUG time were used to describe improvements in mobility following the combined rTMS and physical therapy intervention.
Secondary outcomes
Muscle strength (handgrip strength)
Muscle strength was assessed using handgrip dynamometry. Handgrip strength provides an objective and reliable measure of overall muscle strength and has been associated with functional status in individuals with chronic post-stroke hemiplegia. Changes in handgrip strength were used to descriptively assess strength improvements following the combined rTMS and physical therapy intervention.
Quality of life SF-36
Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), a validated questionnaire evaluating multiple domains of perceived physical and mental health. The SF-36 includes eight domains, each scored from 0 to 100, where higher scores indicate better health-related quality of life. Changes in SF-36 scores were used to describe patient-reported improvements in quality of life following the combined rTMS and physical therapy intervention.
HADS-D
The HADS-D (Hospital anxiety depression scale) is a 7-item self-report subscale assessing depressive symptoms. Each item is scored from 0 to 3, with total scores ranging from 0 to 21; higher scores indicate greater severity of depressive symptoms.
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