跳至主要内容
临床试验/NCT06658249
NCT06658249招募中不适用

Comparative Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program on Pain, Physical Function and Quality of Life in Patients With Knee Osteoarthritis.

Riphah International University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
2
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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