Osteoarthritis (OA) of the KneeNCT07309003
The Effects of Functional Electrical Stimulation (FES) and Exercise on the Quadriceps in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis (OA) of the Knee, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
In our study, we aimed to compare the effects of functional electrical stimulation (FES) and an exercise program on quadriceps muscle strength and structural characteristics, as well as their impact on gait analysis, pain severity, and quality of life, in order to determine more effective and beneficial treatment… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- functional electrical stimulation (FES)
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jan 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, male or female, aged 50-65, who present to Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, are diagnosed with osteoarthritis classified as Kellgren-Lawrence radiographic stage 2-3, and agree to participate in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 1 recruiting
- Completed
Ankara Bilkent Şehir Hastanesi
Ankara, Ankara, 06800
- Recruiting
Ankara Bilkent City Hospital
Ankara
Filiz Acar Sivas, MD, Professor, +905057266755, filiz_sivas@yahoo.com
About this study
Official title: 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
In our study, we aimed to compare the effects of functional electrical stimulation (FES) and an exercise program on quadriceps muscle strength and structural characteristics, as well as their impact on gait analysis, pain severity, and quality of life, in order to determine more effective and beneficial treatment programs for patients with knee OA.
Read the detailed description
The study is planned as a prospective trial. Seventy patients, male or female, aged 50-65, who present to Ankara Bilkent City Hospital, Physical Therapy and Rehabilitation Hospital as outpatients, are diagnosed with osteoarthritis classified as Kellgren-Lawrence radiographic stage 2-3, and agree to participate in the study will be included.
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
- Osteoarthritis (OA) of the Knee
- Being tested
- functional electrical stimulation (FES)
- Keywords
- FES, Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional electrical stimulation (FES)Device
FES-Cycling
| Study group | Role | What they receive |
|---|---|---|
| FES-Cycling | knee osteoarthritis Receives: Device: functional electrical stimulation (FES) | |
| Cycling | knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength
The patients' knee extensor and flexor muscle strengths were evaluated using the Diers Myoline Isometric Muscle Strength Measurement System. After positioning the individuals on the device, their name, surname, age, weight, and height information was recorded. They were then informed about how the test would be conducted and shown videos demonstrating the measurement procedure. For whichever muscle strength was being measured, they were instructed to perform the movement with maximal effort and to hold the muscle contraction isometrically for 10 seconds, after which the results were recorded.
Measurement of patients' muscle strength before treatment, on the 10th day, and at the 6th week.
Measured: From enrollment to the end of treatment at 6 weeks
Visual Analog Scale (VAS)
Zero indicates no pain at all, while 10 represents the worst possible pain.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start3 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül KÜÇÜK GÜRSOY, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309003
- Sponsor's protocol ID
- TABED 2-24-28
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 17691402
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07309003
- Acronym / sponsor ID
- TABED 2-24-28
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- FES, Knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In our study, we aimed to compare the effects of functional electrical stimulation (FES) and an exercise program on quadriceps muscle strength and structural characteristics, as well as their impact on gait analysis, pain severity, and quality of life, in order to determine more effective and beneficial treatment programs for patients with knee OA.
Detailed description
The study is planned as a prospective trial. Seventy patients, male or female, aged 50-65, who present to Ankara Bilkent City Hospital, Physical Therapy and Rehabilitation Hospital as outpatients, are diagnosed with osteoarthritis classified as Kellgren-Lawrence radiographic stage 2-3, and agree to participate in the study will be included.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES-Cycling | – | Device: functional electrical stimulation (FES)knee osteoarthritis |
| Cycling | – | –knee osteoarthritis |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, male or female, aged 50-65, who present to Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital as outpatients, are diagnosed with osteoarthritis classified as Kellgren-Lawrence radiographic stage 2-3, and agree to participate in the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional electrical stimulation (FES)FES-Cycling | Device | FES-Cycling |
Primary outcome
Quadriceps muscle strength
Time frame: From enrollment to the end of treatment at 6 weeks
The patients' knee extensor and flexor muscle strengths were evaluated using the Diers Myoline Isometric Muscle Strength Measurement System. After positioning the individuals on the device, their name, surname, age, weight, and height information was recorded. They were then informed about how the test would be conducted and shown videos demonstrating the measurement procedure. For whichever muscle strength was being measured, they were instructed to perform the movement with maximal effort and to hold the muscle contraction isometrically for 10 seconds, after which the results were recorded. Measurement of patients' muscle strength before treatment, on the 10th day, and at the 6th week.
Visual Analog Scale (VAS)
Time frame: From enrollment to the end of treatment at 6 weeks
Zero indicates no pain at all, while 10 represents the worst possible pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 17691402Newham DJ, Donaldson Nde N. FES cycling. Acta Neurochir Suppl. 2007;97(Pt 1):395-402. doi: 10.1007/978-3-211-33079-1_52.
- Individual participant dataSharing planned: Yes
Related trials for Osteoarthritis (OA) of the Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA) of the Knee, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Küçük Gürsoy, MD (+905393828686, betulkucukgursoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle strength (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07309003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.