"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"

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSierra Varona SL

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • rTMS

    Device

    Repetitive 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 intervention

    The 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

20 Participants
are divided into 2 treatment groups
Group A: rTMS GroupExperimental treatment 2 interventions
Group B: physical therapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
2

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

Time frame
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
3

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.

Time frame
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Secondary outcomes

1

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.

Time frame
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
2

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.

Time frame
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
3

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.

Time frame
aseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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