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

Effect of Transcranial Direct Current Stimulation and Pelvic Proprioceptive Neuromuscular Facilitation in Stroke Patient

2. september 2026 opdateret af: Lahore University of Biological and Applied Sciences

Effects of Transcranial Direct Current Stimulation and Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control, Balance and Functional Mobility in Stroke Patients

Stroke is a leading cause of long-term disability and commonly results in impaired trunk control, postural instability, balance deficits, and reduced functional mobility due to disrupted sensorimotor integration, impaired proprioceptive processing, and decreased cortical excitability. Trunk control is a key determinant of balance, gait performance, and functional independence, making it a critical target in stroke rehabilitation. Transcranial Direct Current Stimulation (tDCS) enhances cortical excitability and promotes neuroplasticity through a top-down mechanism, while Pelvic Proprioceptive Neuromuscular Facilitation (PNF) improves trunk-pelvic control, weight shifting, and sensorimotor integration through a bottom-up proprioceptive facilitation mechanism. Emerging evidence suggests that combining tDCS with Pelvic PNF may improve trunk function and mobility in stroke survivors, supporting the concept of synergistic neuromodulation and motor facilitation. Despite the documented benefits of tDCS and Pelvic PNF individually, the combined application of these interventions remains insufficiently explored, particularly in subacute stroke patients. Most previous studies have focused on gait training, robotic rehabilitation, or other task-oriented interventions, with limited emphasis on trunk-focused pelvic PNF and postural control outcomes. Furthermore, few high-quality randomized controlled trials have evaluated whether simultaneous targeting of central neuroplasticity and peripheral proprioceptive facilitation provides superior improvements in trunk control, balance, and functional mobility. Therefore, this study aims to address this important clinical and methodological gap by investigate the combining effect of Pelvic PNF and tDCS, potentially establishing an evidence-based rehabilitation strategy that optimizes functional recovery after stroke.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Stroke is a neurological disorder caused by a disruption of blood supply because of cerebral infarction or hemorrhage. Stroke is a leading cause of long-term disability worldwide, with balance impairment recognized as one of the most disabling sequel affecting functional independence and quality of life. In Pakistan, the annual incidence of stroke is estimated at 250 per 100,000 people, and stroke is the second leading cause of death with a mortality rate of about 9.3%. Postural control and balance impairment are common issues among patients with stroke. It has been estimated that approximately 83% of patients with stroke experience difficulties in maintaining balance. Effective trunk control, often referred to as core stability, is therefore a fundamental component of motor performance and postural control. Selective trunk exercises designed to improve trunk coordination and control can boost balance and gait parameters among stroke subjects. Transcranial direct current stimulation (tDCS) is one of the most used noninvasive brain stimulation techniques. Transcranial direct current stimulation (tDCS) is a means of increasing cortical excitability by promoting synaptic plasticity in the cerebral cortex. A new "top-down" approach to enhance stroke rehabilitation outcomes. The Pelvic Proprioceptive Neuromuscular Facilitation facilitates the control of trunk and lower extremity motion and provide mobility and stability to trunk. The use of Pelvic PNF facilitates neuromuscular coordination through specific movement patterns, which enhance trunk stability and postural control. The Pelvic PNF facilitates the trunk and lower extremity motion and also provides the stability to trunk. It also promotes the exploration of postural reflexes and prioritizes eccentric muscle contraction, stimulating agonist activity. Pelvic Proprioceptive Neuromuscular Facilitation (PNF) improves trunk-pelvic control, weight shifting, and sensorimotor integration through a bottom-up proprioceptive facilitation mechanism. This study will contribute to knowledge by providing evidence regarding the combined effects of Pelvic PNF and tDCS on trunk control, balance, and functional mobility in subacute stroke patients. The findings will contribute to the existing body of knowledge by providing evidence regarding synergistic effect of these interventions. Clinically the results may help physiotherapist develop more effective, evidence-based treatment protocols for improving trunk control and functional independence. By comparing these groups, the study will determine whether adding tDCS to Pelvic PNF provides better functional recovery by enhancing both cortical excitability and peripheral proprioceptive input. This is important because stroke rehabilitation currently lacks clear evidence on the most effective combination of top-down (neuromodulation) and bottom-up (sensorimotor facilitation) approaches. The findings may help establish a more effective, evidence-based intervention strategy for trunk control and mobility impairments, which are key determinants of independence after stroke. At the community level, improved balance and mobility can reduce fall risk, decrease dependency on caregivers, enhance participation in daily and social activities, and better quality of life. Additionally, effective rehabilitation may reduce long-term disability and healthcare burden, making stroke management more cost-effective and accessible for the community. Experimental Group A will receive Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical Therapy while Experimental Group B will receive Pelvic PNF and Routine Physical Therapy and Experimental Group C Transcranial Direct Current Stimulation and Routine Physical Therapy. . Therefore, this study aims to address this important clinical and methodological gap by investigate the combining effect of Pelvic PNF and tDCS, potentially establishing an evidence-based rehabilitation strategy that optimizes functional recovery after stroke.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
36

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Dr Salma Physiotherapy Department Psrd Hospital 042-37423455

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Both genders
  • Middle Cerebral Artery Ischemic Stroke
  • Subacute phase of stroke
  • Patients experiencing their first ever stroke
  • Brunnstrom stage 3
  • Patients is capable to follow commands

Exclusion Criteria:

  • Frequent seizures or epileptic disorder
  • Contractures in the spine and lower limb
  • Patients with uncontrolled medical conditions e.g. severe musculoskeletal pain, uncontrolled heart disease, uncontrolled hypertension
  • Metallic implant
  • History of brain tumor, orthopedic, neurosurgical surgery
  • Concurrent participation in another clinical trial.

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

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Experimental: Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical therapy
group A will receive pelvic propriceptive neuromuscualar facilitation and transcranial direct current stimulation with routine physical therapy. The participants will receive 20 min session of transcranial direct current stimulation with intensity of 2 mA in which anodal tDCS applied over ipsilateral side. Then 20 min session of pelvic PNF will perform with 10 repitition per set for 3 set. pelvic PNF pattern perform as anterior elevation and posterior elevation using rthymic initiation, slow reversal and stabilizing reversal will perform, Then perform routine therapy as ROM, Bridging, trunk flexion and swiss ball perform for 20 minutre.
Andet: Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical Therapy
The patients will sit comfortably on a chair, with their hip and knee joints positioned at 90 degrees and their forearms resting on a table in front of the chair. For the groups receiving tDCS, a wireless rechargeable tDCS device will use. This device use two 5-7 cm-long sponge electrodes that will soak in 0.9% saline. The electrodes will be carefully wrap around the patient's head. The brain remains excited for up to 20 min following tDCS. The tDCS will administered at a intensity of 2 mA, for 20 min, with a 30 sec ramp-up and ramp-down at the beginning and end of stimulation. The PNF will be perform at 10 repetitions per set, with 3sets per session, conducted 3 sessions per week over a duration of 12 weeks. Each session lasted 20 min. Pelvic PNF pattern as anterior elevation and posterior elevation using rthymic initiation and slow reversal. RPT include ROM, trunk flexion, bridging and swiss ball exercises.
Eksperimentel: Experimental: Pelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy
Group B will receive pelvic proprioceptive neuromuscular facilitation with routine physical therapy. In this group patient receive 20 min session of pelvic PNF with 10 repititions per set for 3 set per session apply moderate manual resistance according to patient tolerance. Patient should be in side lying position then apply PNF pattern as anterior and posterior elevation using rthymic initiation , slow reversal and stabilizing reversal. the routine physical therapy involve 20 repetition with moderate intensity with 3 sessions per week it involve the ROM, bridging, trunk flexion and exercise on swiss ball.
Andet: Pelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy
The PNF treatment will be perform at a dosage of 10 repetitions per set, with 3sets per session, conducted 3 sessions per week over a duration of 12 weeks. Each session lasted 20 minutes, depending on the participant's endurance and response to therapy. The treatment will performed on the affected side, with the hips flexed to 100° and the knees flexed to 45°. For anterior elevation, the therapist's hands will placed just on the subject's anterior iliac spine, and for posterior depression, they will placed on the patient's ischial tuberosity. "Pull up" for anterior elevation, and "push down" and "sit into my hands" for posterior depression. Rhythmic initiation, Slow reversal and stabilizing reversal will used. routine physical therapy involve Sitting posture exercises as controlled forward flexion, trunk rotation to right and left. Supine position exercises as hip roll to both sides, bridging exercise Dynamic sitting exercise on swiss ball as controlled lateral weight shifting.
Eksperimentel: Experimental: Transcranial Direct Current Stimulation and Routine Physical Therapy
Group C will receive transcranial direct current stimulation and routine physical therapy. The participants will receive 20 min session. tDCS pads will soaked in saline and then apply to patients head. Anodal tDCS apply over ipsilesional side with current of 2mA with 30 second ramp up and down in the begining and end of stimulation. the routine physical therapy involve 20 repetition with moderate intensity with 3 sessions per week it involve the ROM, bridging, trunk flexion and exercise on swiss ball.
Andet: Transcranial Direct Current Stimulation and Routine Physical Therapy
The patients will sit comfortably on a chair, with their hip and knee joints positioned at 90 degrees and their forearms resting on a table in front of the chair. For the groups receiving tDCS, a wireless rechargeable tDCS device will use. This device use two 5-7 cm-long sponge electrodes that will soak in 0.9% saline. The electrodes will be carefully wrap around the patient's head. The brain remains excited for up to 20 min following tDCS. The tDCS will administered at a intensity of 2 mA, for 20 min, with a 30 sec ramp-up and ramp-down at the beginning and end of stimulation. routine physical therapy involve Sitting posture exercises as controlled forward flexion, trunk rotation to right and left. Supine position exercises as hip roll to both sides, bridging exercise Dynamic sitting exercise on swiss ball as controlled lateral weight shifting for 20 min duration

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trunk impairement scale
Tidsramme: [Time Frame: baseline, week 6 and week 12]
Trunk impairment scale evaluates static and dynamic trunk balance and trunk coordination. These tasks are design to reflect the patient's ability to activate trunk musculature, which is often impaired after stroke. It evaluates three components: static sitting balance (score range 0-7), dynamic sitting balance (0-10), and trunk coordination (0-6). The total score ranges from 0 to 23, with higher scores indicating better trunk performance.
[Time Frame: baseline, week 6 and week 12]
Berg Balance Scale
Tidsramme: baseline, week 6 and week 12
The BBS is a 14-item ordinal scale that measures balance performance during functional tasks such as sitting, standing, and weight shifting. Each item is rate on a 5-point scale (0-4), with a maximum total score of 56. Higher scores indicate better balance ability. It has excellent inter-rater reliability, with ICC values of 0.989. Concurrent validity (r = 0.970). Interpretation of 0 to 20 (High Risk): Severe balance impairment; patients typically require a wheelchair for mobility and significant assistance. 21 to 40 (Moderate Risk): Increased fall risk; these individuals typically require walking aids and environmental modifications. 41 to 56 (Low Risk): Good balance function with minimal fall risk.
baseline, week 6 and week 12
Time up and go test
Tidsramme: baseline, week 6 and week 12
This test measures functional mobility and fall risk by timing the patient as they rise from a chair, walk a short distance, turn around, return, and sit down. The time taken is record in seconds and categorized into normal mobility, low, moderate, or high fall. Reliability ICC for the TUG were 0.998 and 0.992
baseline, week 6 and week 12
Fugl-Meyer Assessment (FMA) for the lower extremity
Tidsramme: baseline, week 6 and week12
This scale measure the motor control in stroke patients. FMA consists of 17 items, with a maximum total score of 34 points. Each task is rate on a 3-point ordinal scale. 0: Movement cannot be performed, 1: Movement can be performed partially, 2: Movement can be performed fully. The higher the score, the better your motor recovery. The scores indicate: 0-10: Severe motor impairment, 11-23: Moderate motor impairment, 24-33: Mild motor impairment, 34: Minimal to no impairment (full motor recovery). Reliability, with Intra-class Correlation Coefficient (ICC) values 0.90 to 0.97 high inter-and intra-rater reliability (ICC > 0.90) for the total FMA-LL score.
baseline, week 6 and week12

Samarbejdspartnere og efterforskere

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

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Lahore University of Biological and Applied Sciences

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: psrd hospital, Pakistan Society for Rehabilitation of Disabled Hospital Lahore

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
23. juli 2026

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. september 2026

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. september 2026

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
2. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
2. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
9. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
2. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • UBAS/ERB/26/07/080

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 .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger