Effect of Core Stability Versus Conventional Exercise for Functional Ambulation of Calf Muscle

Not Applicable

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06766877
• Lead Sponsor: Dow University of Health Sciences

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.

Detailed Description

The objective of the study is:

1. To determine the interrater and intrarater reliability of digital calliper to measure the side to side Achilles tendon thickness.

2. To determine the impact of 24 sessions of core stability translated in gait ambulation.

3. determines the relationships between Achilles tendon thickness (ATT), knee symptoms/functions, and foot alignment in knee OA patients, considering their interconnected biomechanical nature.

4. compare the effects of core stability and ankle-foot strengthening exercises on clinical outcomes in KOA patients

Study Timeline

• Study Start: 2023-07-22
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-04
• Study First Posted: 2025-01-09
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-02-22
• Study Completion: 2025-02-23

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire	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).
Visual Analogue Scale (VAS) at rest	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.
Stair climb test	8 weeks	change from baseline, time taken to ascend and descend the stairs
Knee flexion range of motion	8 weeks	Change from baseline, flexion was assessed with a goniometer
knee extension range of motion	8 weeks	change from baseline, extension was assessed with goniometer
Achilles tendon thickness	8 weeks	Change from baseline, tendon thickness was measured was assessed with digital calliper
30 second chair test	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.
Timed up and go test	8 weeks	The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults
40 meter walk test	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.
Gastrocnemius muscle strength	8 weeks	Patient to perform plantar flexion in the form of single-limb heel raise
navicular/foot ratio	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.
Ankle range of motion	8 weeks	The dorsiflexion range of ankle movement was evaluated using the knee-to-wall lunge technique

Trial Locations

Locations (1)

BIPTRM; 🇵🇰 Karachi, Sindh, Pakistan