Functional electrical stimulation versus exercise for strengthening the quadriceps in knee osteoarthritis
Investigation of the Correlation With Clinical Data of the Effects of Functional Electrical Stimulation (FES) and Exercise on Quadriceps Muscle Strength and Structural Characteristics in Patients With Knee Osteoarthritis
This project will try functional electrical stimulation (FES) versus a supervised exercise program to see which better builds quadriceps strength and improves pain, walking, and quality of life for people aged 50–65 with moderate knee osteoarthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 2 sites (Ankara, Ankara and 1 other locations) |
| Trial ID | NCT07309003 on ClinicalTrials.gov |
What this trial studies
This is a prospective, outpatient study enrolling 70 patients aged 50–65 with primary knee osteoarthritis classified as Kellgren-Lawrence grade 2–3 at Ankara Bilkent City Hospital. Baseline measures include pain (VAS), WOMAC, SF-36, 6-minute walk test, Timed Up and Go, ultrasound measures of quadriceps thickness and rectus femoris cross-sectional area, isometric knee strength with the Diers Myoline, and gait analysis with the Zebris FDM3, with several assessments recorded in a blinded fashion. Participants will receive either functional electrical stimulation or a structured exercise program and outcomes on strength, muscle structure, gait, pain, and quality of life will be compared over the treatment period. The goal is to identify which approach provides greater functional and symptomatic benefit for people with moderate knee OA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50–65 with primary knee OA meeting ACR criteria and Kellgren-Lawrence grade 2–3 who can adhere to an exercise regimen and have no recent knee surgery or injections.
Not a fit: Patients with secondary OA, active synovitis, recent major knee trauma or surgery, recent intra-articular injections, uncontrolled systemic diseases (including diabetes with neuropathy), neurological or vestibular disorders, or cardiopulmonary conditions that contraindicate exercise are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, the preferred approach could produce stronger quadriceps, reduced pain, and improved walking ability and quality of life for people with moderate knee osteoarthritis.
How similar studies have performed: Previous small rehabilitation trials and post-operative studies have shown that both FES and targeted exercise can improve quadriceps strength and function, but direct head-to-head comparisons in moderate knee OA are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being between 50-65 years of age * 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: * Having a diagnosis of secondary OA * 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
Where this trial is running
Ankara, Ankara and 1 other locations
- Ankara Bilkent Şehir Hastanesi — Ankara, Ankara, Turkey (Türkiye) (Completed)
- Ankara Bilkent City Hospital — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Betül Küçük Gürsoy, MD
- Email: betulkucukgursoy@gmail.com
- Phone: +905393828686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.