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Completed

NCT Number: NCT04227860

Balance and Strength Exercise in Knee Osteoarthritis Patients

The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of Medicine

Alexandria, 00123, Egypt

About this study

The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):

Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA

  • Patients will undergo pre-exercise and post- exercise assessment with:
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
  • Modified Stare Excursion Balance test
  • Timed up and Go test
  • Exercise program includes:
  • Lower extremity kinesthesia and balance exercise program
  • Strength exercise program

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
  • Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)

Exclusion criteria

  • Patients that cannot complete at least stage 1 of balance and exercise program
  • Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
  • Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
  • Patients with secondary KOA.
  • Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.

Treatment and study plan

Balance exercise program

Other

Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks.

Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.

Strengthening exercise program

Other

Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks.

Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.

Primary outcomes

  1. Assessment of pain

    Time frame: 2-6 weeks

    Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain.

  2. Assessment of stiffness

    Time frame: 2-6 weeks

    Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness.

  3. Assessment of physical function

    Time frame: 2-6 weeks

    Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient.

Secondary outcomes

  1. Dynamic Balance

    Time frame: 2-6 weeks

    Using the Modified star excursion balance test which measures the patients dynamic balance in several directions, giving the patient 3 attempts and measuring each time and taking a mean of the 3 measurements in each. An increase in the measurements means better dynamic balance and a smaller measurement means worse dynamic balance.

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2020
Registry last updated
May 26, 2022

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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