Knee OsteoarthritisNCT05836792
The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis
A study testing Cycle Ergometer, Transcutaneous electrical nerve stimulation and Ultrasound in people with Knee Osteoarthritis and Sensation Disorders, run by Nilay Aral at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Sensation Disorders
- What is being tested?
- Cycle Ergometer, Transcutaneous electrical nerve stimulation and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Knee osteoarthritis (Kellgren-Lawrance score between 1-3)
Who cannot join
- Previous knee surgery
- Diabetus Mellitus
- Thyroid disease
- Visual deficit
- Gait disorder
- Mental Disability
- Presence of neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis, Sensation Disorders
- Being tested
- Cycle Ergometer, Transcutaneous electrical nerve stimulation, Ultrasound, Isometric exercises
- Keywords
- Knee Osteoarthritis, Deep Sensation, Cycle Ergometer, Biofeedback
- Medical subject headings
- Osteoarthritis, Knee, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ErgometerOther
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.
Transcutaneous electrical nerve stimulationDevice
Also called TENS
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.
UltrasoundDevice
Also called US
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
Isometric exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Cycle Ergometer Group (CEG) | Experimental | Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer Receives: Other: Cycle Ergometer; Device: Transcutaneous electrical nerve stimulation; Device: Ultrasound; Other: Isometric exercises |
| Control Group | Active comparator | Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Receives: Device: Transcutaneous electrical nerve stimulation; Device: Ultrasound; Other: Isometric exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diapason survey
Diapason will be used to survey vibration sense to evaluate deep sensation
Measured: 3 weeks
Digital Goniometer
Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation.
Measured: 3 weeks
6 Minute Walking Test (6MWT)
Six Minute walking test will be used to evaluate functional capacity of volunteers
Measured: 3 weeks
Secondary outcomes (2)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
WOMAC is a patient-reported outcome measure for the assessment of lower limb osteoarthritis
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start20 Apr 2023
- Primary completion2 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilay Aral
- Sponsor type
- University, hospital or other
- Collaborators
- Sante Medical Center
- Responsible party
- Sponsor-investigator, Nilay Aral, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836792
- Sponsor's protocol ID
- 20203034001
- Status last verified
- Mar 2026
- First submitted
- 19 Apr 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05836792
- Acronym / sponsor ID
- 20203034001
- Conditions
- Knee Osteoarthritis, Sensation Disorders
- Keywords
- Knee Osteoarthritis, Deep Sensation, Cycle Ergometer, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nilay AralUniversity, hospital or other
- Collaborators
- Sante Medical Center
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 May 2023 (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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle Ergometer Group (CEG) | Experimental | Other: Cycle Ergometer, Device: Transcutaneous electrical nerve stimulation, Device: Ultrasound, Other: Isometric exercisesIsometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer |
| Control Group | Active comparator | Device: Transcutaneous electrical nerve stimulation, Device: Ultrasound, Other: Isometric exercisesIsometric exercises Transcutaneous electrical nerve stimulation Ultrasound |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Knee osteoarthritis (Kellgren-Lawrance score between 1-3)
Key exclusion criteria (7 listed)
- Previous knee surgery
- Diabetus Mellitus
- Thyroid disease
- Visual deficit
- Gait disorder
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 |
|---|---|---|
| Cycle ErgometerPatients 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. | Other | Cycle Ergometer Group (CEG) |
| Transcutaneous electrical nerve stimulationAlso: TENSTranscutaneous 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. | Device | Control Group, Cycle Ergometer Group (CEG) |
| UltrasoundAlso: USUltrasound 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 | Device | Control Group, Cycle Ergometer Group (CEG) |
| Isometric exercisesThe 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 | Other | Control Group, Cycle Ergometer Group (CEG) |
Primary outcome
Diapason survey
Time frame: 3 weeks
Diapason will be used to survey vibration sense to evaluate deep sensation
Digital Goniometer
Time frame: 3 weeks
Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation.
6 Minute Walking Test (6MWT)
Time frame: 3 weeks
Six Minute walking test will be used to evaluate functional capacity of volunteers
2 secondary outcomes
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 3 weeks
Physical Activity Scale for the Elderly (PASE)
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle Ergometer, Transcutaneous electrical nerve stimulation and Ultrasound in people with Knee Osteoarthritis and Sensation Disorders, run by Nilay Aral at 1 site 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diapason survey (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.