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Enrolling by Invitation

NCT Number: NCT06766877

Effect of Core Stability Versus Ankle Foot Strengthening Exercise in the Management of Knee Osteoarthritis

Knee osteoarthritis (KOA) is a degenerative joint disease causing pain, stiffness, and reduced quality of life. While treatments often focus on drugs or surgery, noninvasive exercises like core stabilization and ankle/foot strengthening show potential but lack comparative studies. Understanding anatomical factors like Achilles tendon (AT) thickness is crucial for targeted rehabilitation, though measurement reliability remains an issue. This study aims to compare the effects of these exercises on KOA symptoms and evaluate the use of digital calipers for AT thickness measurement, aiming to enhance clinical management of 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

BIPTRM

Karachi, Sindh, Pakistan

About this study

The objective of the study is:

  • To determine the interrater and intrarater reliability of digital calliper to measure the side to side Achilles tendon thickness.
  • To determine the impact of 24 sessions of core stability translated in gait ambulation.
  • determines the relationships between Achilles tendon thickness (ATT), knee symptoms/functions, and foot alignment in knee OA patients, considering their interconnected biomechanical nature.
  • compare the effects of core stability and ankle-foot strengthening exercises on clinical outcomes in KOA patients

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 40 years old, had been diagnosed with KOA based on ACR, and
  • having Grade II or III osteoarthritis by K/L criteria.

Exclusion criteria

  • post-traumatic osteoarthritis
  • lower limb sensorimotor dysfunction,
  • 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 stability exercise

Other
  • Isometric quadriceps exercises involving knee extension
  • Maximum isometric exercise for the quadriceps

foot-ankle strengthening exercise

Other
  • Isometric quadriceps exercises involving knee extension
  • Maximum isometric exercise for the quadriceps

Primary outcomes

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

    Time frame: 8 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).

  2. Visual Analogue Scale (VAS) at rest

    Time frame: 8 weeks

    Changes from baseline, Visual Analogue Scale (VAS) 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 VAS.

  3. Stair climb test

    Time frame: 8 weeks

    change from baseline, time taken to ascend and descend the stairs

  4. Knee flexion range of motion

    Time frame: 8 weeks

    Change from baseline, flexion was assessed with a goniometer

  5. knee extension range of motion

    Time frame: 8 weeks

    change from baseline, extension was assessed with goniometer

  6. Achilles tendon thickness

    Time frame: 8 weeks

    Change from baseline, tendon thickness was measured was assessed with digital calliper

  7. 30 second chair test

    Time frame: 8 weeks

    change from baseline, The 30 Second Sit to Stand Test is also known as 30 Second Chair Stand Test (30CST), was initially designed for testing leg strength and endurance in older adults.

  8. Timed up and go test

    Time frame: 8 weeks

    The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults

  9. 40 meter walk test

    Time frame: 8 weeks

    Instruct patient to walk as quickly, but as safely as possible, without running, along 10m walkway, past the taped line, & then turn around cone & return.

  10. Gastrocnemius muscle strength

    Time frame: 8 weeks

    Patient to perform plantar flexion in the form of single-limb heel raise

  11. navicular/foot ratio

    Time frame: 8 weeks

    The midfoot alignment was assessed using the navicular/foot ratio, which is calculated as the ratio of the navicular height to the total foot length.

  12. Ankle range of motion

    Time frame: 8 weeks

    The dorsiflexion range of ankle movement was evaluated using the knee-to-wall lunge technique

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Mar 25, 2026

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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