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Completed

NCT Number: NCT05836792

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sensation Disorders Signs and Symptoms

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sante Medical Center

Istanbul, Kadıköy, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Cycle ergometer

Other

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 stimulation

Device

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.

Other names: TENS

Ultrasound

Device

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

Other names: US

isometric exercises

Other

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

Primary outcomes

  1. Diapason survey

    Time frame: 3 weeks

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

  2. Digital Goniometer

    Time frame: 3 weeks

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

  3. 6 Minute Walking Test (6MWT)

    Time frame: 3 weeks

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

Secondary outcomes

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

    Time frame: 3 weeks

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

  2. Physical Activity Scale for the Elderly (PASE)

    Time frame: 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

Nilay Aral

Other

Collaborators

  • Sante Medical Center

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 1, 2023
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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