Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients With Knee Osteoarthritis

July 7, 2024 updated by: Sibel Gayretli Atan, Istanbul University
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients with Knee Osteoarthritis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators divided patients with knee osteoarthritis into two groups. Group 1 consisted of stage 1 and stage 2 patients. Group 2 consisted of stage 3 and stage 4 patients. Proprioceptive training was applied in both groups. Investigators aim is to evaluate the effect of proprioceptive exercises on knee osteoarthritis according to the radiological level.

Study Type

Interventional

Enrollment (Actual)

34

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 Locations

  • Turkey
    • Istanbul
      • Uskudar, Istanbul, Turkey, 34668
        • Istanbul Health Sciences University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with knee osteoarthritis by a specialist physician using MRI, US or radiography and physical examination.
  • Being between the ages of 35-70
  • Stage 1-2-3-4 according to Kellegran Lawrence (K-L) in radiological examination

Exclusion Criteria:

Having active synovitis

  • Having received physical therapy in the last 6 months
  • Those with neurological problems that affect walking
  • Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise
  • Has had lower extremity surgery in the past
  • Intra-articular steroid injections within the last 6 months
  • Using psychoactive drugs
  • Those with serious vision, hearing and speech disorders
  • Patients with vestibular dysfunction will not be included in the study

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
This group includes patients with grade 1 and grade 2 knee osteoarthritis.
Other: Proprioceptive training
Proprioceptive exercises were applied to both groups. In addition to these exercises, balance, coordination and strengthening exercises will also be applied to both groups.
Experimental: Group 2
This group includes patients with grade 3 and grade 4 osteoarthritis.
Other: Proprioceptive training
Proprioceptive exercises were applied to both groups. In addition to these exercises, balance, coordination and strengthening exercises will also be applied to both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Evaluation will be performed before treatment and after 4 weeks rehabilitation program.
The scale consists of 3 main headings and 24 questions. It is scored between 0 and 100. There is a negative correlation between scoring and functionality.
Evaluation will be performed before treatment and after 4 weeks rehabilitation program.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proprioception Sense
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The sense of proprioception will be measured using a digital goniometer. It will be repeated 3 times. The average will be recorded
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Visual Analogue Scale (VAS)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS)..Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Pressure Pain Threshold Measurement
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
A digital algometer will be used for Pressure Pain Threshold Measurement. Digital algometer is a device that objectively evaluates the pressure pain threshold. Low values indicate increased sensitivity and pain sensation.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Range of Motion (ROM)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Knee,food and hip ROM will be evaluated with digital goniometer while the patient will be in supine and prone position.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Timed Up and Go Test (TUG)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The scale consists of 7 questions measuring the physical activity of the individual in the last 7 days. The activity level is determined according to the scale score.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Manual Muscle Test
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Short Form 36 (SF-36)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
SF-36 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Global Rating of Change (GRC) Scale
Time Frame: 4 weeks
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
4 weeks
International Physical Activity Scale (IPAQ)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The scale consists of 7 questions measuring the physical activity of the individual in the last 7 days. The activity level is determined according to the scale score.
Evaluation will be performed at Baseline (before treatment) and 4 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Sibel Gayretli Atan, sssibel_38@hotmail.com

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)

November 21, 2023

Primary Completion (Actual)

December 21, 2023

Study Completion (Actual)

April 5, 2024

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBU

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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