Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

"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. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Andet: 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.
Aktiv komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Motor function (FMA)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle strength (handgrip strength)
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sierra Varona SL

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. juni 2026

Primær færdiggørelse (Anslået)

15. juli 2026

Studieafslutning (Anslået)

30. august 2026

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Sierra Varona SL

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk slagtilfælde

Kliniske forsøg med rTMS

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in United Kingdom

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner