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CompletedNCT05836792Updated Mar 25, 2026

The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis

An interventional study of Cycle Ergometer and Transcutaneous electrical nerve stimulation in Knee Osteoarthritis and Sensation Disorders, sponsored by Nilay Aral. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by Nilay Aral · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study summary

The aim of the randomized controlled study is to investigate the effects of the cycle ergometer with biofeedback on deep sensation in elderly people who has knee osteoarthritis

Read the detailed description

Participants will be randomly divided and registered into 2 groups: Thera-train tigo group (TG) or control group(CP)

For 20 participants 20 minute tens, 5 minute ultrasound, 10 times with 2 sets quadriceps isometric exercise will be applied. The other 20 participants will use Thera-train tigo for 20 minute in addition to tens, us, quadriceps isometric exercise.

Conditions of the participants will be measured before(1st day) and after(15th day) a span of 3 week treatment. We will use Demographic Information Questionnaire, Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, Physical Activity Scale for the Eldery (PASE) and 6 minute walking test for all patients. Then we will measure knee vibration sense with diapason. Knee joint position sense will be measured with a digital goniometer.

02

Conditions studied

  • Knee Osteoarthritis
  • Sensation Disorders

Keywords

  • Knee Osteoarthritis
  • Deep Sensation
  • Cycle Ergometer
  • Biofeedback
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

This is the only study on the registry with Nilay Aral as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Knee osteoarthritis (Kellgren-Lawrance score between 1-3)

Exclusion criteria

Exclusion Criteria:

  • Previous knee surgery
  • Diabetus Mellitus
  • Thyroid disease
  • Visual deficit
  • Gait disorder
  • Mental Disability
  • Presence of neuropathy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Cycle Ergometer Group (CEG)

    Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer

    Other: Cycle Ergometer · Device: Transcutaneous electrical nerve stimulation · Device: Ultrasound · Other: Isometric exercises

  • Active comparator
    Control Group

    Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound

    Device: Transcutaneous electrical nerve stimulation · Device: Ultrasound · Other: Isometric exercises

Interventions

  • OtherCycle Ergometer

    Patients will attend cycle ergometer exercise. Volunteers will monitor their pedaling forces as right and left force. They will try to make these forces equal while they are pedaling.

  • DeviceTranscutaneous electrical nerve stimulation

    Transcutaneous electrical nerve stimulation will be used for the reduction of pain. TENS will be used 5 times in a week for 3 weeks. Each procedure will take 20 minutes.

    Also known as: TENS

  • DeviceUltrasound

    Ultrasound will be used for increase the permeability of cells to treat pain and inflammation. US will be used 5 times in a week for 3 weeks. Each procedure will take 5 minutes

    Also known as: US

  • OtherIsometric exercises

    The aim of the isometric exercises is increasing muscle strength. Each session patients will do quadriceps isometric exercises 5 times in a week for 3 weeks

06

What researchers measure

Primary outcomes

  1. Diapason survey

    Diapason will be used to survey vibration sense to evaluate deep sensation

    Time frame: 3 weeks

  2. Digital Goniometer

    Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation.

    Time frame: 3 weeks

  3. 6 Minute Walking Test (6MWT)

    Six Minute walking test will be used to evaluate functional capacity of volunteers

    Time frame: 3 weeks

Secondary outcomes

  1. The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    WOMAC is a patient-reported outcome measure for the assessment of lower limb osteoarthritis

    Time frame: 3 weeks

  2. Physical Activity Scale for the Elderly (PASE)

    Physical Activity Scale for the Elderly (PASE) will be used to evaluate the physical activities of individuals. Higher scores show the higher physical activity level.

    Time frame: 3 weeks

07

Study locations

1 site
  • Sante Medical Center
    Istanbul, Kadıköy, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05836792
Lead sponsor
Nilay Aral
Collaborators
Sante Medical Center
Responsible party
Nilay Aral (Physiotherapist, Yeditepe University) — Sponsor-investigator
First posted
May 1, 2023
Start date
Apr 20, 2023
Primary completion
May 2, 2023
Completion
Jun 30, 2023
Last update
Mar 25, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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