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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03920020
Other study ID # KA 17168
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 28, 2019
Est. completion date December 31, 2021

Study information

Verified date April 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in 42 patients with knee osteoarthritis enrolled the study.


Description:

This study aims to compare the effects of concentric and eccentric isokinetic exercises on proprioception and muscle architecture in patients with knee osteoarthritis. 42 patients will be included in this study. Patients will be divided into three groups; concentric exercise group (n:14), eccentric exercise group (n:14) and control group (n:14). A conventional physiotherapy program and a standard therapeutic exercise program will be applied to all subjects. In addition to these exercise and physiotherapy programme, concentric and eccentric exercise groups will perform the exercises related to their groups. All three groups will participate in this program for a total of 18 sessions 3 times a week for 6 weeks. All groups will be subject to re-evaluation after 6 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of primary knee osteoarthritis according to American College of Radiology - Being radiographically K-L grade 2-3 - Presence of symptoms for at least 3 months - Patients who have been planned a conventional physiotherapy programme because of knee osteoarthritis - Presence of functional capacity for outpatient physical therapy Exclusion Criteria: - Patients with seconder knee osteoarthritis - History of lower extremity or spine surgery - History of intraarticular injection in last 1 month - Patients with neurological disease that will affect muscle strength, balance and coordination

Study Design


Related Conditions & MeSH terms


Intervention

Other:
the concentric isokinetic exercise group
concentric isokinetic exercises
the eccentric isokinetic exercise group
eccentric isokinetic exercises
the control group
conventional physiotherapy and standard therapeutic exercises predetermined by us

Locations

Country Name City State
Turkey Institute of Health Sciences Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Joint position sense Joint position sense will be evaluated with isokinetic dynamometer at predetermined angles. 6 weeks
Primary Ultrasonographic assessment of quadriceps and hamstring muscles Ultrasonographic evaluation is an outcome measure to evaluate muscle structure. In our study ultrasonographic evaluation will be performed to determine the muscle structure (muscle thickness(mm), fascicle length(mm), pennation angle(degree)) of quadriceps and hamstring muscles. Muscle thickness will be defined as the distance between the deeper and upper aponeurosis. The pennation angle will be calculated as the angle of insertion of muscle fascicles into the deep aponeurosis. Fascicle length will be defined as the length of the fascicular path between the superficial and deep aponeurosis. 6 weeks
Secondary WOMAC (Western Ontario & McMaster Universities Osteoarthritis Index) WOMAC Osteoarthritis Index (score range 0-100) include 3 subscales and will be used to evaluate knee pain(score range 0-20), stiffness (score range 0-8), and functional limitation (score range -68). Womac is comprised of 24 items ( pain-5 items, stiffness-2 items, physical function-17 items). All items are scored on a scale of 0-4. Lower scores indicate lower disability. 6 weeks
Secondary Range of motion Universal goniometer will be used for assessment of range of motion of the knee 6 weeks
Secondary Muscle strength assessment isokinetic dynamometer test will be used. 6 weeks
Secondary Shortness of muscles assessment universal goniometer will be used for assessment 6 weeks
Secondary Pain assessment: VAS (Visual analog scale) VAS is used to measure the psycometric pain severity in some conditions and activities. A VAS is usually a 100 mm long horizontal line. The scale is most commonly anchored by "no pain" (line's left, score-0), "pain as bad as it could be" (line's right, score-100). the score is determined by measuring the distance between the "no pain" anchor and the patient's mark. 6 weeks
Secondary Balance assessment Single leg standing test with eyes open and closed will be used. Timing is recorded. 6 weeks
Secondary The timed up and go test TUG test is used to measure functional mobility. It gives an idea about patients walking ability, fall risk and balance. The patient is asked to get up, walk 3 meters and sit down again.Timing begins when the patient rise from the chair and stops when the patient sit down. 6 weeks
Secondary Sit to stand test Patients stand up from and sit down on a chair as quickly as possible 5 times. Patients folded their arms across their chests. Timing is recorded. 6 weeks
Secondary Timed 10 meter walk test This test is used to assess walking speed. Timing is recorded. 6 weeks
Secondary Short Form 12 (SF-12) health survey SF-12 is an 12- item questionnare for assessing self-reported health related quality of life. It covers eight domains of health outcomes, including physical functioning, role physical, bodily pain, general health, vitality, social functioning,role-emotional, mental health. Sf-12 physical and mental component summary scales are scored. Lower SF-12 score indicated poorer physical and mental health. 6 weeks
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