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

• Sponsor: Yeditepe University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05836792
• Collaborator: Sante Medical Center (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.3
• Patients Per Site Per Month: 17.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Sensation Disorders	Other: Cycle Ergometer; Device: Transcutaneous electrical nerve stimulation; Device: Ultrasound; Other: Isometric exercises	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Cycle Ergometer With Biofeedback on Deep Sensation in Elderly Patients With Knee Osteoarthritis
• Actual Study Start Date: Apr 20, 2023
• Anticipated Primary Completion Date: May 2, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cycle Ergometer Group (CEG) Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer	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.; Other Names: TENS ; Device: 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 Names: US ; 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
Active Comparator: Control Group Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound	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.; Other Names: TENS ; Device: 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 Names: US ; 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

Outcome Measures

Primary Outcome Measures

1. Diapason survey [3 weeks]

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

2. Digital Goniometer [3 weeks]

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

3. 6 Minute Walking Test (6MWT) [3 weeks]

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

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sante Medical Center	Istanbul	Kadıköy	Turkey

Sponsors and Collaborators

• Yeditepe University
• Sante Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nilay Aral, Physiotherapist, Yeditepe University
• ClinicalTrials.gov Identifier: NCT05836792
• Other Study ID Numbers: 20203034001
• First Posted: May 1, 2023
• Last Update Posted: May 1, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nilay Aral, Physiotherapist, Yeditepe University: Knee Osteoarthritis; Deep Sensation; Cycle Ergometer; Biofeedback
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Sensation Disorders

Study Results

No Results Posted as of May 1, 2023