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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05836792
Other study ID # 20203034001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date June 30, 2023

Study information

Verified date June 2023
Source Yeditepe University
Contact Nilay Aral, Licence
Phone +905344805231
Email nilayaral@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 30, 2023
Est. primary completion date June 2, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility 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

Study Design


Intervention

Other:
Cycle 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.
Device:
Transcutaneous 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.
Ultrasound
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:
Isometric 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

Locations

Country Name City State
Turkey Sante Medical Center Istanbul Kadiköy

Sponsors (2)

Lead Sponsor Collaborator
Nilay Aral Sante Medical Center

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diapason survey Diapason will be used to survey vibration sense to evaluate deep sensation 3 weeks
Primary Digital Goniometer Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation. 3 weeks
Primary 6 Minute Walking Test (6MWT) Six Minute walking test will be used to evaluate functional capacity of volunteers 3 weeks
Secondary The Western Ontario and McMaster Universities Arthritis Index (WOMAC) WOMAC is a patient-reported outcome measure for the assessment of lower limb osteoarthritis 3 weeks
Secondary 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. 3 weeks
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