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

NCT06766877 | Enrolling By Invitation DMC

• 1 other identifier: BMU/Approval?
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

knee; arthritis; tendon

Outcome Measures

Primary Outcomes (12)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire

  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).

  8 weeks

• Visual Analogue Scale (VAS) at rest

  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.

  8 weeks

• Stair climb test

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

  8 weeks

• Knee flexion range of motion

  Change from baseline, flexion was assessed with a goniometer

  8 weeks

• knee extension range of motion

  change from baseline, extension was assessed with goniometer

  8 weeks

• Achilles tendon thickness

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

  8 weeks

• 30 second chair test

  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 weeks

• Timed up and go test

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

  8 weeks

• 40 meter walk test

  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.

  8 weeks

• Gastrocnemius muscle strength

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

  8 weeks

• navicular/foot ratio

  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.

  8 weeks

• Ankle range of motion

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

  8 weeks

Study Arms (2)

Core Stability

EXPERIMENTAL

Core Stability exercises: Bridging Lateral Step up etc

Other: core stability exercise

Foot-ankle strengthening exercise

ACTIVE COMPARATOR

resistance exercises with proper warm up and cool down

Other: foot-ankle strengthening exercise

Interventions

foot-ankle strengthening exercise OTHER

1. Isometric quadriceps exercises involving knee extension 2. Maximum isometric exercise for the quadriceps

Foot-ankle strengthening exercise

core stability exercise OTHER

1. Isometric quadriceps exercises involving knee extension 2. Maximum isometric exercise for the quadriceps

Core Stability

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

BIPTRM

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• SHAIKH NABI BUKHSH NAZIR, PhD Scholar

  Dow University of Health Sciences/ Baqai Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 9, 2025
• Study Start: July 22, 2023
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)