- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03615521
Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis
Diz Osteoartritinde Farklı Proprioseptif Nöromüsküler Fasilitasyon Tekniklerinin, Ağrı, Propriosepsiyon, Postural Kontrol, Kas Kuvveti, Eklem Hareket Açıklığı ve Diz Fonksiyonları Üzerine Olan Etkileri
Study Overview
Status
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Hacettepe
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Repeated Contraction Exercise Group
Repeated Contractions Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute and Repeated Stretch (Repeated Contractions) exercise.
Repeated Contractions exercise is type of Proprioceptive Neuromusculer Facilititation Exercise.
3 session for 6 weeks.
|
Hotpack applied 20 minutes for knee 3 session for 6 weeks
Ultrasound applied 10 minutes for knee 3 session for 6 weeks
Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week
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Experimental: Combine Exercise Group
Combination of Isotonics Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute Combination of Isotonics Exercise. Combination of Isotonics Exercise is type of PNF. Combined concentric, eccentric, and stabilizing contractions of one group of muscles (agonists) without relaxation. 3 Session for 6 weeks. |
Hotpack applied 20 minutes for knee 3 session for 6 weeks
Ultrasound applied 10 minutes for knee 3 session for 6 weeks
Proprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week
|
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Experimental: Standart Exercise Therapy
Classic Physiotherapy: Hotpack, Ultrasound, Standart exercise program to improve Quadriceps, Hamstring and hip muscle strength. 3 session for 6 weeks. |
Hotpack applied 20 minutes for knee 3 session for 6 weeks
Ultrasound applied 10 minutes for knee 3 session for 6 weeks
Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise. 3 session for 6 week |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps Femoris Muscle Strength
Time Frame: 6 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knee Proprioception (30-45 and 60 degree)
Time Frame: 6 week
|
Proprioception is evaluated with Biodex System (30-45 and 60 degree)
|
6 week
|
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KOOS score
Time Frame: 6 week
|
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.
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6 week
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Step test
Time Frame: 6 week
|
Climb and step in 10 steps.
Brief time is better.
|
6 week
|
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Womac Score
Time Frame: 6 week
|
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
|
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6 Minute walking test
Time Frame: 6 week
|
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.
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6 week
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Balance
Time Frame: 6 week
|
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
|
|
Knee Pain Severity
Time Frame: 6 week
|
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.
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6 week
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Algometer
Time Frame: 6 week
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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.
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6 week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time up and go test
Time Frame: 6 week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Filiz Can, Prof., Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/09-36 (KA-17112)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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