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

Primary Purpose

Knee Osteoarthritis, Sensation Disorders

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Cycle Ergometer

Transcutaneous electrical nerve stimulation

Ultrasound

Isometric exercises

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, Deep Sensation, Cycle Ergometer, Biofeedback

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sante Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cycle Ergometer Group (CEG)

Control Group

Arm Description

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound

Outcomes

Primary Outcome Measures

Diapason survey

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

Digital Goniometer

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

6 Minute Walking Test (6MWT)

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

Secondary Outcome Measures

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

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

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.

Full Information

NCT ID

NCT05836792

First Posted

April 19, 2023

Last Updated

June 20, 2023

Sponsor

Nilay Aral

Collaborators

Sante Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT05836792

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2023 (Actual)

Primary Completion Date

June 2, 2023 (Actual)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nilay Aral

Collaborators

Sante Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis, Sensation Disorders

Keywords

Knee Osteoarthritis, Deep Sensation, Cycle Ergometer, Biofeedback

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cycle Ergometer Group (CEG)

Arm Type

Experimental

Arm Description

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound

Intervention Type

Other

Intervention Name(s)

Cycle Ergometer

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Transcutaneous electrical nerve stimulation

Other Intervention Name(s)

TENS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Ultrasound

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Isometric exercises

Intervention Description

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 Outcome Measure Information:

Title

Diapason survey

Description

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

Time Frame

3 weeks

Title

Digital Goniometer

Description

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

Time Frame

3 weeks

Title

6 Minute Walking Test (6MWT)

Description

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Description

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

Time Frame

3 weeks

Title

Physical Activity Scale for the Elderly (PASE)

Description

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.

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nilay Aral, Licence

Phone

+905344805231

nilayaral@gmail.com

Facility Information:

Facility Name

Sante Medical Center

City

Istanbul

State/Province

Kadıköy

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gülseren Akyüz, Professor

gulserena@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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