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

NCT ID: NCT05836792

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis Sensation Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Cycle Ergometer Group (CEG)

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer

Group Type EXPERIMENTAL

Cycle Ergometer

Intervention Type OTHER

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.

Transcutaneous electrical nerve stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Isometric exercises

Intervention Type OTHER

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

Control Group

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound

Group Type ACTIVE_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Isometric exercises

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type 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

Intervention Type DEVICE

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

Intervention Type OTHER

Other Intervention Names

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TENS US

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sante Medical Center

OTHER

Sponsor Role collaborator

Nilay Aral

OTHER

Sponsor Role lead

Responsible Party

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Nilay Aral

Physiotherapist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sante Medical Center

Istanbul, Kadıköy, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nilay Aral, Licence

Role: CONTACT

+905344805231

Facility Contacts

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Gülseren Akyüz, Professor

Role: primary

Other Identifiers

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20203034001

Identifier Type: -

Identifier Source: org_study_id

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