Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program in Patients With Knee Osteoarthritis.

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis (OA)

• Registration Number: NCT06658249
• Lead Sponsor: Riphah International University

Brief Summary

Knee osteoarthritis (OA) is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. It is most common in the elder population. It results from functional disability and altered knee biomechanics. Risk factors of Knee OA include; older age, genetics and obesity, female gender. The aim of this study is to compare the effects of core stabilization exercises versus foot-ankle strengthening program on pain, physical function and quality of life in patients with knee osteoarthritis.

Detailed Description

A Randomized Clinical Trial will be conducted at Riphah Physiotherapy Clinic Lahore, FMH Physiotherapy Department, Hamza Hospital Physiotherapy Clinic, Lahore through convenient purposive sampling technique 46 patients which will be allocated by using simple randomization through computer generated software into Group A and Group B. Group A will be treated with core stabilization exercises and ankle-foot strengthening program and Group B will be treated with ankle-foot strengthening program at the frequency of 3 sets with 10 repetitions thrice per week in the total duration of 6 weeks. Outcome measures will be conducted through (NPRS), (WOMAC), Knee Osteoarthritis Outcome Score (KOOS) Questionnaire and quality of life (SF-36) questionnaire before and after 6 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Study Timeline

• Study Start: 2024-01-04
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-01-07
• Study Completion: 2025-01-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Both genders of 40-65 years of age will include in this study.
• Knee OA of grade 1-2.
• Individuals with significant unilateral and bilateral knee osteoarthritis. symptoms and positive radio-graphical findings.
• Difficulty in walking/stair climbing.

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Exclusion Criteria

• Any history of knee fracture/ tumor/ infection and hip/knee surgery.
• Total Knee Replacement patients.
• Neurological disease.
• Patient received physical therapy treatment from last 6 months.
• Inflammatory Arthritis (Rheumatoid Arthritis)
• Use of any intra-articular injections (steroid/ hyaluronic acid/ PRP.) from last 3-6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	6 weeks	Changes from baseline, Numeric Rating Scale (NRS) is the most commonly used scale in which the pain rate ranges from 0 (no pain) to 10 (worst pain). The level of knee perception of pain is assessed by using the NPRS. It is used as the outcome measure tool for patients with OA knee. The NPRS is consider as reliable, valid, and responsive scale for pain. This scale has high reliability (0.95-0.96).; The validity of NPRS ranges from (0.86-0.95).
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire	6 weeks	Changes from baseline, KOOS score consist of five patient-relevant dimensions that are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. This scale consist of total 42-items and score of this scale range from 0 (severe knee pathology) to 100 (no knee problem). This tool has been use to assess the pain, symptoms, activities level, function in knee osteoarthritis patients. It is a valid tool for Knee Osteoarthritis patients ; validity ranges up-to (0.80-0.89).
WESTREN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC SCALE)	6 weeks	Changes from baseline, WOMAC scale consist of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores have been represent worse pain, stiffness, and functional limitations. This scale will be use to assess pain, stiffness, physical function level in knee osteoarthritis patients.
36- Items Short Form Survey (SF-36) QUESTIONNAIRE	6 weeks	Changes from baseline, Quality of life scale (SF-36) questionnaire consist of subscale of general health, activities limitations, physical health problems, emotional health problems, social activities, energy and emotions; total 36 items in it. SF-36 is used to assess the quality of life in knee osteoarthritis patient. SF-36 questionnaire is reliable and valid tool for quality of life in knee osteoarthritis individuals.

Trial Locations

Locations (1)

Fatima Memorial Hospital Physical Therapy Department; 🇵🇰 Lahore, Punjab, Pakistan