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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836792
• Other study ID #: 20203034001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Sensation Disorders

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