- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06766877
Effect of Core Stability Versus Ankle Foot Strengthening Exercise in the Management of Knee Osteoarthritis
March 22, 2026 updated by: Shaikh Nabi Bukhsh Nazir, Dow University of Health Sciences
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- BIPTRM
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Foot-ankle strengthening exercise
resistance exercises with proper warm up and cool down
|
|
|
Experimental: Core Stability
Core Stability exercises: Bridging Lateral Step up etc |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
8 weeks
|
|
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.
|
8 weeks
|
|
Stair climb test
Time Frame: 8 weeks
|
change from baseline, time taken to ascend and descend the stairs
|
8 weeks
|
|
Knee flexion range of motion
Time Frame: 8 weeks
|
Change from baseline, flexion was assessed with a goniometer
|
8 weeks
|
|
knee extension range of motion
Time Frame: 8 weeks
|
change from baseline, extension was assessed with goniometer
|
8 weeks
|
|
Achilles tendon thickness
Time Frame: 8 weeks
|
Change from baseline, tendon thickness was measured was assessed with digital calliper
|
8 weeks
|
|
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 weeks
|
|
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
|
8 weeks
|
|
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.
|
8 weeks
|
|
Gastrocnemius muscle strength
Time Frame: 8 weeks
|
Patient to perform plantar flexion in the form of single-limb heel raise
|
8 weeks
|
|
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.
|
8 weeks
|
|
Ankle range of motion
Time Frame: 8 weeks
|
The dorsiflexion range of ankle movement was evaluated using the knee-to-wall lunge technique
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: SHAIKH NABI BUKHSH NAZIR, PhD Scholar, Dow University of Health Sciences/ Baqai Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2023
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
January 2, 2025
First Submitted That Met QC Criteria
January 4, 2025
First Posted (Actual)
January 9, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2026
Last Update Submitted That Met QC Criteria
March 22, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMU/Approval?
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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