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

June 20, 2023 updated by: Nilay Aral
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Kadıköy
      • Istanbul, Kadıköy, Turkey
        • Recruiting
        • Sante Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nilay Aral

Collaborators

Sante Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2023

Primary Completion (Actual)

June 2, 2023

Study Completion (Estimated)

June 30, 2023

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20203034001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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