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CompletedNCT04227860Updated May 26, 2022

Balance and Strength Exercise in Knee Osteoarthritis Patients

An interventional study of Balance exercise program and Strengthening exercise program in Knee Osteoarthritis, sponsored by University of Alexandria. Completed at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-05-26.

Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study summary

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).

Read the detailed description

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:

    1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
    2. Modified Stare Excursion Balance test
    3. Timed up and Go test
  • Exercise program includes:

    1. Lower extremity kinesthesia and balance exercise program
    2. Strength exercise program
02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Alexandria is the lead sponsor of 57 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Group 1: G I primary KOA

    Exercise and balance training

    Other: Balance exercise program · Other: Strengthening exercise program

  • Active comparator
    Group 2: G II primary KOA

    Exercise and balance training

    Other: Balance exercise program · Other: Strengthening exercise program

  • Active comparator
    Group 3: G III primary KOA

    Exercise and balance training

    Other: Balance exercise program · Other: Strengthening exercise program

  • Active comparator
    Group 4: G IV primary KOA

    Exercise and balance training

    Other: Balance exercise program · Other: Strengthening exercise program

Interventions

  • OtherBalance exercise program

    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.

  • OtherStrengthening exercise program

    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.

06

What researchers measure

Primary outcomes

  1. Assessment of pain

    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.

    Time frame: 2-6 weeks

  2. Assessment of stiffness

    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.

    Time frame: 2-6 weeks

  3. Assessment of physical function

    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.

    Time frame: 2-6 weeks

Secondary outcomes

  1. Dynamic Balance

    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.

    Time frame: 2-6 weeks

07

Study locations

1 site
  • Alexandria University, Faculty of Medicine
    Alexandria, 00123, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04227860
Lead sponsor
University of Alexandria
Responsible party
Yousra Hisham Abdel Fattah (Lecturer of Physical Medicine, Rheumatology and Rehabilitation, University of Alexandria) — Principal investigator
First posted
Jan 14, 2020
Start date
Jan 20, 2020
Primary completion
Jun 1, 2021
Completion
Dec 31, 2021
Last update
May 26, 2022

Study contacts

Yousra H Abdel Fattah
principal investigator · Alexandria University Faculty of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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