The Effects of Functional Electrical Stimulation (FES) and Exercise on the Quadriceps in Patients With Knee Osteoarthritis
NCT ID: NCT07309003
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
52 participants
OBSERVATIONAL
2025-01-03
2025-12-30
Brief Summary
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Detailed Description
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According to the research criteria, initial evaluations will be conducted, and the demographic data (such as age, gender, height, weight, date of birth, occupation, systemic diseases) of eligible patients will be recorded by Dr. Betül Küçük Gürsoy. Patients' personal information will remain confidential and will not be shared with any person or institution/organization.
At the start of treatment, the VAS pain score, WOMAC, Quality of Life (SF-36) Scale, 6-Minute Walk Test (6-MWT), and Timed Up and Go Test (TUGT) will be recorded by Dr. Betül Küçük Gürsoy. Quadriceps muscle thickness and rectus femoris cross-sectional area will be measured via ultrasonography and recorded in a blinded manner by Dr. Ayşe Merve Ata.
Concurrently, isometric muscle strength measurements of the knee flexor and extensor groups using the Diers Myoline system will be performed and recorded in a blinded manner by Physiotherapist Selin Koç. Gait analysis (cadence, step length, stride length, step width, foot angle, and walking speed) using the Zebris FDM3 device will be conducted and recorded by Dr. Betül Küçük Gürsoy.
Subsequently, patients will be divided into two groups. The first group will receive aerobic exercise (stationary cycling) 5 times a week for a total of 10 sessions, administered by Dr. Betül Küçük Gürsoy. Additionally, they will be given a 6-week home exercise program to be performed 3 times a week, consisting of knee flexor and extensor range of motion exercises and isometric strengthening. The second group will receive Functional Electrical Stimulation-Cycling (FES-Cycling) 5 times a week for a total of 10 sessions, administered by Dr. Betül Küçük Gürsoy. They will also be given the same 6-week home exercise program (3 times a week) consisting of knee range of motion and isometric strengthening exercises.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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FES-Cycling
knee osteoarthritis
functional electrical stimulation (FES)
FES-Cycling
Cycling
knee osteoarthritis
No interventions assigned to this group
Interventions
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functional electrical stimulation (FES)
FES-Cycling
Eligibility Criteria
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Inclusion Criteria
* Having knee OA (primary) according to ACR criteria
* Having grade 2-3 knee OA according to the Kellgren-Lawrence classification
* Having the ability to adhere to exercise regimens
* Agreeing to participate in the study
Exclusion Criteria
* History of major knee trauma, surgery, or intra-articular steroid/hyaluronic acid injection in the last 6 months
* Presence of active synovitis
* Presence of neurological (Parkinson's, Alzheimer's, Polyneuropathy), endocrinological (diabetes mellitus), or vestibular disorders that could affect functional status, pain severity, or proprioception; or any disease that impairs these factors
* Pulmonary or cardiovascular disease that contraindicates exercise
* History of fracture and/or surgery in the lower extremity
50 Years
65 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Betül KÜÇÜK GÜRSOY
DOCTOR
Locations
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Ankara Bilkent Şehir Hastanesi
Ankara, Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Filiz Acar Sivas, MD, Professor
Role: primary
References
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Newham DJ, Donaldson Nde N. FES cycling. Acta Neurochir Suppl. 2007;97(Pt 1):395-402. doi: 10.1007/978-3-211-33079-1_52.
Other Identifiers
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TABED 2-24-28
Identifier Type: -
Identifier Source: org_study_id