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Functional Electrical Stimulation Versus Whole-Body Vibration in Post-Stroke Rehabilitation

1. juni 2026 oppdatert av: Riphah International University

Comparative Effects of Functional Electrical Stimulation and Whole Body Vibration Training on Lower Limb Motor Control, Balance and Physical Performance in Post-Stroke Patients

This study will compare the effects of Functional Electrical Stimulation (FES) and Whole Body Vibration Training (WBVT) on lower limb motor control, balance, and physical performance in post-stroke patients. It will be a single-blinded randomized clinical trial including 34 participants, who will be allocated into two groups. Both groups will receive their respective interventions 4 days per week for 8 weeks. Outcomes will be assessed at baseline and after 8 weeks using the Fugl-Meyer Assessment for lower extremity motor control, Berg Balance Scale for balance, and Barthel Index for physical performance.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Stroke is an acute focal injury of the central nervous system caused by a vascular source, which results in neurological deficits and can cause disability or death. Stroke can lead to motor weakness, sensory deficiency and loss of motor control. Patients who have had a stroke frequently experience issues with their balance, gait and physical performance. Whole-Body Vibration Training (WBVT) is a non-pharmacological intervention that transmits vibration stimulation throughout the body and has demonstrated promise in improving balance, mobility, and physical function in stroke rehabilitation. Functional Electrical Stimulation (FES) is a rehabilitation technique that helps stroke survivors regain motor skills by stimulating certain nerves with electrical impulses applied via the skin's surface, which causes paretic muscles to move. FES can be utilized to improve physical performance, muscle strength, and balance in stroke patients. Strokes frequently lead to poor physical performance, diminished balance, and impaired lower limb motor control, all of which have an adverse effect on daily functioning and quality of life. This study aims to compare the effects of Functional Electrical Stimulation and Whole Body Vibration Training on lower limb motor control, balance, and physical performance in post-stroke patients.

Studietype

Intervensjonell

Registrering (Antatt)

34

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Pakistan
    • Punjab Province
      • Gujrat, Punjab Province, Pakistan, 50700
        • Hafiz Physiotherapy Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • the patient is between the ages of 35 and 70.
  • Both male and female participants will be included.
  • Chronic post-stroke patients from 6 months to 1 year.
  • Stroke patients who have a neurological impairment.
  • Individuals who experienced a single stroke in either the left or right hemisphere of the brain.
  • Lower limb motor impairment with Fugl-Meyer Lower Extremity Score ≤ 28.
  • Barthel Index Score ≥ 60.
  • Berg Balance Scale Score ≥ 21.

Exclusion Criteria:

patients suffering from unstable cardiac condition, severe hypertension, congestive heart failure, aphasia, or cognitive impairments for which exercises are contraindicated.

  • Patients with recurrent stroke.
  • Patients undergoing other form of lower limb stimulation therapy concurrently.
  • Severe orthopedic conditions or joint deformities affecting lower limb.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Functional Electrical Stimulation Group
Participants in this arm will receive transcutaneous Functional Electrical Stimulation for lower limb rehabilitation for 8 weeks. Stimulation will be applied to selected lower limb muscles including tibialis anterior, quadriceps, hamstrings, and peroneal muscles. Treatment parameters will progress according to tolerance, including intensity, session duration, and functional movement integration. Outcomes will be assessed at baseline and after 8 weeks.
Enhet: Functional Electrical Stimulation
Functional Electrical Stimulation will be delivered transcutaneously to selected lower limb muscles for 8 weeks. Stimulation will target tibialis anterior, quadriceps, hamstrings, peroneal muscles, and other lower limb muscles according to patient need and tolerance. The intervention will use biphasic symmetrical pulsed current with progressive intensity, duration, and functional movement integration. Treatment will be supervised by a physiotherapist, and outcomes will be assessed at baseline and after 8 weeks.
Andre navn:
  • Nevromuskulær elektrisk stimulering
  • FES
  • Electrical Stimulation Therapy
Aktiv komparator: Whole Body Vibration Training Group

Participants in this arm will receive Whole Body Vibration Training using a vibration platform for 8 weeks. Training will include progressive activities such as standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance. Vibration frequency, duration, and exercise difficulty will be gradually progressed according to tolerance. Outcomes will be assessed at baseline and after 8 weeks.

After this, go to Interventions and add Functional Electrical Stimulation and Whole Body Vibration Training, then assign each intervention to its matching arm.
Enhet: Whole Body Vibration Training
Whole Body Vibration Training will be delivered using a vibration platform for 8 weeks. Participants will perform progressive lower limb activities including standing, semi-squat, heel raises, dynamic squatting, side-to-side weight shifting, and one-leg stance exercises. Frequency, duration, and difficulty will be progressed according to patient tolerance under physiotherapist supervision.
Andre navn:
  • Whole Body Vibration
  • WBV Training

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
lower Limb Motor Control
Tidsramme: Baseline and 8 weeks post-intervention
Assessed using the Fugl-Meyer Assessment for Lower Extremity.
Baseline and 8 weeks post-intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Balance
Tidsramme: Baseline and 8 weeks post-intervention
Assessed using the Berg Balance Scale.
Baseline and 8 weeks post-intervention
Physical Performance
Tidsramme: Baseline and 8 weeks post-intervention
Assessed using the Barthel Index Scale.
Baseline and 8 weeks post-intervention

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Riphah International University

Etterforskere

  • Studiestol: Ambreen Iqbal IQBAL, Riphah International University Role

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2025

Primær fullføring (Antatt)

6. juli 2026

Studiet fullført (Antatt)

6. august 2026

Datoer for studieregistrering

Først innsendt

1. juni 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NOOR NAZISH

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The individual participant data sharing plan has not yet been finalized.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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