Balance, Chronic Stroke
Conditions
Keywords
repetitive transcraneal magnetic stimulation, chronic stroke, motor recovery, balance, physical therapy
Brief 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.
Detailed description
Chronic post-stroke hemiplegia is associated with persistent motor impairment, balance deficits, and reduced quality of life. Although physical therapy remains the cornerstone of rehabilitation, functional recovery frequently plateaus in the chronic phase. Strategies that enhance neuroplasticity and potentiate the effects of rehabilitation may help optimize long-term outcomes. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique capable of modulating cortical excitability within motor networks. When applied to the motor cortex, rTMS may facilitate neuroplastic changes that support motor recovery, particularly when combined with task-oriented physical therapy. This prospective case series investigates the feasibility, safety, and clinical effects of a combined intervention consisting of repetitive transcranial magnetic stimulation and conventional physical therapy in individuals with chronic post-stroke hemiplegia. Participants meeting predefined eligibility criteria will undergo a protocol integrating rTMS sessions with a structured physical therapy program focused on motor function, balance training, and functional mobility. Clinical assessments will be conducted before and after completion of the intervention to evaluate changes in motor performance, balance abilities, and health-related quality of life. Safety will be monitored throughout the study, with adverse events recorded and managed in accordance with established guidelines for non-invasive brain stimulation and physical therapy. This case series is intended to generate preliminary clinical evidence regarding the combined use of rTMS and physical therapy in the chronic post-stroke population and to inform the design of future controlled clinical trials.
Interventions
DEVICErTMS
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.
OTHERphysical therapy
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.
Sponsors
Sierra Varona SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding was implemented at the outcome assessment and data analysis levels. Outcome assessors responsible for administering clinical and functional tests were not involved in the intervention delivery and were unaware of group allocation. Data were anonymized and coded prior to statistical analysis, and the statistician conducted all analyses using masked group labels. Due to the nature of the transcranial stimulation intervention, care providers delivering the treatment and study investigators were not blinded.
Intervention model description
Randomized parallel-group interventional study in which patients with stroke were allocated to either transcranial stimulation plus conventional rehabilitation or conventional rehabilitation alone. Participants remained in their assigned group throughout the study, with no crossover between intervention arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor function (FMA) | Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up. | 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 | Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up. | 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 | Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up. | 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
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength (handgrip strength) | Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up. | 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 | Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up. | 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 | aseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up. | 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. |
Contacts
CONTACTALBERTO SANCHEZ SIERRA, PhD
Outcome results
None listed