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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis; Sensation Disorders
• Interventions: Device: Transcutaneous electrical nerve stimulation; Other: Cycle Ergometer; Device: Ultrasound; Other: Isometric exercises

• Registration Number: NCT05836792
• Lead Sponsor: Nilay Aral

Brief 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

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 Timeline

• Study First Submitted: 2023-04-19
• Study Start: 2023-04-20
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-02
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycle Ergometer Group (CEG)	Ultrasound	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer
Control Group	Transcutaneous electrical nerve stimulation	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound
Cycle Ergometer Group (CEG)	Transcutaneous electrical nerve stimulation	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer
Cycle Ergometer Group (CEG)	Cycle Ergometer	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer
Cycle Ergometer Group (CEG)	Isometric exercises	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer
Control Group	Ultrasound	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound
Control Group	Isometric exercises	Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound

Primary Outcome Measures

Name	Time	Method
6 Minute Walking Test (6MWT)	3 weeks	Six Minute walking test will be used to evaluate functional capacity of volunteers
Digital Goniometer	3 weeks	Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation.
Diapason survey	3 weeks	Diapason will be used to survey vibration sense to evaluate deep sensation

Secondary Outcome Measures

Name	Time	Method
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	3 weeks	WOMAC is a patient-reported outcome measure for the assessment of lower limb osteoarthritis
Physical Activity Scale for the Elderly (PASE)	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.

Trial Locations

Locations (1)

Sante Medical Center; 🇹🇷 Istanbul, Kadıköy, Turkey