- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07784998
Gender Based Comparison of the Effects of Sensory Modulated Graded Weight Bearing Physiotherapy In Adults With Knee Osteoarthritis (GSMGWBP)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Punjab Province
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Gujar Khan, Punjab Province, Pakistan
- Rekrutacyjny
- T.H.Q hospital
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Kontakt:
- Dr.Sarmaad Kayyani, MBBS
- Numer telefonu: +923005088112
- E-mail: Sarmaadkayyani@gmail.com
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Główny śledczy:
- Sadia Akhtar, DPT
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
|
|
Eksperymentalny: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Pain Intensity Measured by the Visual Analog Scale (VAS), 0-10; lower scores indicate less pain
Ramy czasowe: 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
|
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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
Ramy czasowe: 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)
Ramy czasowe: Baseline, Week 3, and Week 6
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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
Ramy czasowe: 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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 189-26
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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