Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

"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"

13 maggio 2026 aggiornato da: Sierra Varona SL

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: rTMS Group
Participants assigned to this arm received low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with task-specific physical therapy. rTMS was applied over the primary motor cortex (M1) of the unaffected hemisphere at a frequency of 1 Hz and an intensity of 90% of the individual resting motor threshold. Each session delivered 1,200 pulses over 20 minutes. Immediately after each rTMS session, participants underwent a standardized physical therapy session focused on lower-limb strengthening and balance training. This combined intervention was designed to modulate interhemispheric inhibition and facilitate motor recovery in individuals with chronic post-stroke hemiplegia.
Dispositivo: rTMS
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.
Altro: physical 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.
Comparatore attivo: physical therapy Group
Participants assigned to this arm received a standardized physical therapy program focused on motor recovery, balance training, and functional mobility in chronic post-stroke hemiplegia. The intervention included task-specific exercises targeting the affected lower limb, muscle strengthening, postural control, and balance activities adapted to individual functional capacity. Therapy sessions were designed according to neurorehabilitation principles and progressed based on patient performance and tolerance. This arm served as a reference intervention to describe functional changes associated with conventional physical therapy in the chronic phase of stroke recovery.
Altro: physical 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Motor function (FMA)
Lasso di tempo: 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.
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
balance
Lasso di tempo: 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
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Functional mobility
Lasso di tempo: 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.
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Muscle strength (handgrip strength)
Lasso di tempo: 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.
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Quality of life SF-36
Lasso di tempo: 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.
Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sierra Varona SL

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 giugno 2026

Completamento primario (Stimato)

15 luglio 2026

Completamento dello studio (Stimato)

30 agosto 2026

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Sierra Varona SL

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Ictus cronico

Prove cliniche su rTMS

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Lebanon

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi