NCT07309003

Brief 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 programs for patients with knee OA.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

November 18, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

FESKnee osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

FES-Cycling

knee osteoarthritis

Device: functional electrical stimulation (FES)

Cycling

knee osteoarthritis

Interventions

FES-Cycling

FES-Cycling

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara Bilkent Şehir Hastanesi

Ankara, Ankara, 06800, Turkey (Türkiye)

COMPLETED

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Betül Küçük Gürsoy, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 30, 2025

Study Start

January 3, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Locations