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Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis (GSMGWBP)

12. september 2026 oppdatert av: Fouzia Batool, Shifa Tameer-e-Millat University
This comparative experimental study aims to evaluate the effectiveness of Sensory-Modulated Graded Weight-Bearing Physiotherapy (SMGWBP) in patients with knee osteoarthritis and compare treatment outcomes between male and female participants. Participants will receive a 6-week physiotherapy program with assessments conducted at baseline (pre-intervention), mid-intervention (3 weeks), and post-intervention (6 weeks) using validated outcome measures.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

Knee osteoarthritis (KOA) is a common degenerative joint disorder associated with pain, impaired physical function, reduced proprioception, decreased mobility, and poor quality of life. Physiotherapy plays a central role in the conservative management of KOA by reducing pain and improving functional performance. Sensory-Modulated Graded Weight-Bearing Physiotherapy (SMGWBP) integrates sensory stimulation with progressive weight-bearing exercises to enhance neuromuscular control, balance, proprioception, and functional recovery.

This comparative experimental study aims to evaluate the effectiveness of SMGWBP in individuals with Kellgren-Lawrence grade II or III knee osteoarthritis and to compare treatment outcomes between male and female participants. A total of 52 participants will be recruited through purposive sampling. All participants will receive a standardized 6-week physiotherapy program consisting of three supervised sessions per week.

Outcome assessments will be performed at three time points: baseline (pre-intervention), mid-intervention (3 weeks), and post-intervention (6 weeks). The primary and secondary outcome measures include pain intensity measured using the Visual Analog Scale (VAS), physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), proprioception using the Joint Position Sense (JPS) test, gait performance using the Six-Minute Walk Test (6MWT), health-related quality of life using the Short Form-36 (SF-36), and treatment compliance. The study will examine changes in these outcomes over time and compare the effectiveness of the intervention between male and female participants.

Studietype

Intervensjonell

Registrering (Antatt)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Punjab Province
      • Gujar Khan, Punjab Province, Pakistan
        • Rekruttering
        • T.H.Q hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sadia Akhtar, DPT

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

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion criteria

  • Participants are eligible for inclusion if they meet the following criteria:
  • Age between 40 and 60 years.
  • Diagnosed with Grade II or Grade III Knee Osteoarthritis according to Kellgren-Lawrence Classification.
  • Ability to ambulate independently without assistive devices.
  • Mild to moderate pain intensity with a Visual Analogue Scale score less than seven.
  • Ability to understand and follow instructions.
  • Willingness to participate and provide written informed consent. Exclusion Criteria
  • Participants are excluded if they meet any of the following criteria:
  • History of knee surgery within the previous six months.
  • Neurological disorders affecting balance, gait, or proprioception.
  • Severe cardiovascular disease limiting participation in exercise.
  • Rheumatoid arthritis or other inflammatory arthritic conditions.
  • Severe cognitive impairment.
  • Any medical condition that contraindicates participation in rehabilitation exercises.

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm 1 - Arm Title: Male Participants
Twenty-six male participants with knee osteoarthritis will receive the Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme for six weeks, with three supervised sessions per week. Outcomes will be assessed at baseline, Week 3, and Week 6.
A structured six-week Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme consisting of three supervised sessions per week (18 sessions total). Each session includes warm-up, sensory modulation, proprioceptive training, graded weight-bearing strengthening, functional mobility exercises, and cool-down activities. The programme progresses through three phases: Weeks 1-2 focus on sensory activation and proprioceptive training; Weeks 3-4 on graded weight-bearing strengthening; and Weeks 5-6 on functional weight-bearing integration. Exercises are progressed according to participant tolerance, pain severity, and functional performance. Both male and female groups receive the same intervention.
Eksperimentell: Arm 2 - Arm Title: Female Participants
Twenty-six female participants with knee osteoarthritis will receive the Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme for six weeks, with three supervised sessions per week. Outcomes will be assessed at baseline, Week 3, and Week 6.
A structured six-week Sensory-Modulated Graded Weight-Bearing Physiotherapy Programme consisting of three supervised sessions per week (18 sessions total). Each session includes warm-up, sensory modulation, proprioceptive training, graded weight-bearing strengthening, functional mobility exercises, and cool-down activities. The programme progresses through three phases: Weeks 1-2 focus on sensory activation and proprioceptive training; Weeks 3-4 on graded weight-bearing strengthening; and Weeks 5-6 on functional weight-bearing integration. Exercises are progressed according to participant tolerance, pain severity, and functional performance. Both male and female groups receive the same intervention.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pain Intensity Measured by the Visual Analog Scale (VAS), 0-10; lower scores indicate less pain
Tidsramme: Baseline, Week 3, and Week 6
To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on pain intensity between male and female patients with knee osteoarthritis
Baseline, Week 3, and Week 6
Change in Physical Function Measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale, 0-68; lower scores indicate better function
Tidsramme: Baseline, Week 3, and Week 6
To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on physical function between male and female patients with knee osteoarthritis
Baseline, Week 3, and Week 6
Change in Knee Joint Proprioception Measured by the Joint Position Sense (JPS) Test (absolute repositioning error in degrees; lower values indicate better proprioception)
Tidsramme: Baseline, Week 3, and Week 6
To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on proprioception between male and female patients with knee osteoarthritis
Baseline, Week 3, and Week 6
Change in mobility Measured by the Six-Minute Walk Test (6MWT), distance walked in meters; higher values indicate better gait performance
Tidsramme: Baseline, Week 3, and Week 6
To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on mobility between male and female patients with knee osteoarthritis
Baseline, Week 3, and Week 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Health-Related Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36), 0-100; higher scores indicate better health-related quality of life
Tidsramme: Baseline, Week 3, and Week 6
To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on health-related quality of life between male and female patients with knee osteoarthritis
Baseline, Week 3, and Week 6

Samarbeidspartnere og etterforskere

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

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)

13. juli 2026

Primær fullføring (Faktiske)

24. august 2026

Studiet fullført (Antatt)

23. september 2026

Datoer for studieregistrering

Først innsendt

17. august 2026

Først innsendt som oppfylte QC-kriteriene

19. august 2026

Først lagt ut (Faktiske)

25. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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