- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07784998
Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis (GSMGWBP)
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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-
Punjab Province
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Gujar Khan, Punjab Province, Pakistan
- Rekrytointi
- T.H.Q hospital
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Ottaa yhteyttä:
- Dr.Sarmaad Kayyani, MBBS
- Puhelinnumero: +923005088112
- Sähköposti: Sarmaadkayyani@gmail.com
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Päätutkija:
- Sadia Akhtar, DPT
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Kokeellinen: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Pain Intensity Measured by the Visual Analog Scale (VAS), 0-10; lower scores indicate less pain
Aikaikkuna: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on pain intensity between male and female patients with knee osteoarthritis
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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
Aikaikkuna: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on physical function between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
|
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Change in Knee Joint Proprioception Measured by the Joint Position Sense (JPS) Test (absolute repositioning error in degrees; lower values indicate better proprioception)
Aikaikkuna: 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
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Baseline, Week 3, and Week 6
|
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Change in mobility Measured by the Six-Minute Walk Test (6MWT), distance walked in meters; higher values indicate better gait performance
Aikaikkuna: Baseline, Week 3, and Week 6
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To compare the effect of Sensory-Modulated Graded Weight-Bearing Physiotherapy on mobility between male and female patients with knee osteoarthritis
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Baseline, Week 3, and Week 6
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 189-26
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