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NCT Number: NCT06658249

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

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.

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Key information

Conditions

Knee Osteoarthritis (OA) Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatima Memorial Hospital Physical Therapy Department

Lahore, Punjab Province, 25000, Pakistan

Location status: Recruiting

Location contact

Areej Kulsoom, MS-OMPT

PRINCIPAL_INVESTIGATOR

Usman Riaz, MS-OMPT

CONTACT

[email protected]

03324708805

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Core Stabilization Exercises with Foot-Ankle Strengthening Program

Other

Core Stabilization Exercises and Foot-Ankle Strengthening Program with the frequency of 3 sets of 10 repetitions 3 times per week for a total duration of 6 weeks. Core Stabilization Exercises include : Double leg Abdominal Press, Single Leg Abdominal Press, Abdominal crunches, Side-lying Hip Abduction, Bridging Exercise, Wall Squats Exercise. Foot-Ankle Strengthening Program include : Step ups Exercise, Heel Raises in standing/sitting, Toe Raises in standing/sitting, Foot-Ankle isometrics with theraband, One leg balance with chair support. Pre and Post intervention values will be taken on 1st day and after 6 weeks. Simple Conventional treatment will also given that include Hot Pack and TENS for 10 minutes and Ultrasound for 5 minutes and Knee Isometric exercises with the frequency of 1 set of 10 repetitions with 5 sec hold with the ratio of 3 times per week for a total duration of 6 weeks.

Other names: Simple Conventional Treatment

Foot-Ankle Strengthening Program

Other

Foot-Ankle Strengthening Program along with common conventional treatment with the frequency of 3 sets of 10 repetition thrice per week for a total duration of 6 weeks. Core Stabilization Exercises include : Double leg Abdominal Press, Single Leg Abdominal Press, Abdominal crunches, Side-lying Hip Abduction, Bridging Exercise, Wall Squats Exercise. Foot-Ankle Strengthening Program include : Step ups Exercise, Heel Raises in standing/sitting, Toe Raises in standing/sitting, Foot-Ankle isometrics with theraband, One leg balance with chair support. Pre and Post intervention values will be taken on 1st day and after 6 weeks. Simple Conventional treatment will also given that include Hot Pack and TENS for 10 minutes and Ultrasound for 5 minutes and Knee Isometric exercises with the frequency of 1 set of 10 repetitions with 5 sec hold with the ratio of 3 times per week for a total duration of 6 weeks.

Other names: Simple Conventional Treatment

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 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).

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire

    Time frame: 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).

  3. WESTREN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC SCALE)

    Time frame: 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.

  4. 36- Items Short Form Survey (SF-36) QUESTIONNAIRE

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, Phd

CONTACT

[email protected]

03324390125

Imran Amjad, Phd

CONTACT

[email protected]

051-5481826

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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