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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03615521
Other study ID # 2017/09-36 (KA-17112)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2018
Est. completion date November 10, 2021

Study information

Verified date February 2022
Source Karamanoglu Mehmetbey University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of 6-week physiotherapy and rehabilitation programs involving different 'Proprioceptive Neuromuscular Facilitation' (PNF) techniques in patients with knee osteoarthritis on pain, proprioception, postural control, muscle strength, range of motion and knee functions


Description:

The results obtained from this study will contribute to the selection of PNF technique which is most suitable for physiotherapies working on knee osteoarthritis in clinics as well as demonstrating the efficacy of PNF which has been studied in the literature very few times. As a result of this study, the evidence value of the PNF technique will be determined in the physiotherapy and rehabilitation program of patients with knee osteoarthritis, and the efficacy of this technique, which is theoretically adopted, will be demonstrated scientifically. It will also determine the most ideal of the two PNF techniques to be applied in patients with knee osteoarthritis


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date November 10, 2021
Est. primary completion date May 20, 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Between the ages of 45-65 - The diagnosis of stage 1-2 osteoarthritis by the orthopedist - Volunteerig for research - No hearing, vision and speech impediment Exclusion Criteria: - Patients with intra-articular contracture, - No Meniscus and no ligament problems - Presence of any neurological or cardiopulmonary disease that may affect the results of the study

Study Design


Intervention

Other:
Hotpack
Hotpack applied 20 minutes for knee 3 session for 6 weeks
Ultrasound
Ultrasound applied 10 minutes for knee 3 session for 6 weeks
Combine Exercise
Proprioceptive Neuromusculer Facilitation Technique Include eccentric and concentric contractions 3 session for 6 week
Repeated Contraction Exercise
Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week
Standart Exercise Therapy
Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise. 3 session for 6 week

Locations

Country Name City State
Turkey Hacettepe Ankara

Sponsors (1)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Time up and go test Patient stand up, walk to the line on the floor and turn around and walk back to the chair and sit down. Start timing on the word "GO" and stop timing when the subject is seated again correctly in the chair with their back resting on the back of the chair.
Normal healthy elderly usually complete the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.
6 week
Primary Quadriceps Femoris Muscle Strength Quadriceps Femoris muscle strength is evaluated Biodex System. Patients performs knee extension strongly and system analyzed. System gives us Peak Torque which indicates the muscle's maximum strength capability.
1 repetition maximum (RM) isotonic strength test.
6 week
Secondary Knee Proprioception (30-45 and 60 degree) Proprioception is evaluated with Biodex System (30-45 and 60 degree) 6 week
Secondary KOOS score KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document: KOOS Scoring). A total score has not been validated and is not recommended. 6 week
Secondary Step test Climb and step in 10 steps. Brief time is better. 6 week
Secondary Womac Score It is a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.
Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
6 week
Secondary 6 Minute walking test The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. "The object of this test is to walk as far as possible for 6 minutes. More walk in a short time is better performance. 6 week
Secondary Balance Balance is evaluated Biodex Balance System (BBS). This device, clinicians can assess neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on a static or unstable surface. In the measurement with the BBS, the personal values of the patient are determined and compared to reference values. Balance deficits are determined on this basis. BBS permits three measurements to be obtained including overall stability index (OSI), anterior-posterior stability index (APSI) and medial-lateral stability index (MLSI). Balance and risk of fall were assessed using two trials over a period of 30 seconds with 10 seconds rest in between. If total score close zero, accepted better. 6 week
Secondary Knee Pain Severity Pain is evaluated with visual analog scale. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. ''0'' means no pain, ''10'' means much pain, ''5'' means moderate pain. 6 week
Secondary Algometer Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold.The handheld algometer had a 1-cm2 round rubber application surface.The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. 6 week
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