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Muscle WeaknessNCT03615521

Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis

A study testing Hotpack, Ultrasound and Combine Exercise in people with Muscle Weakness and Balance Disorders, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Muscle Weakness, Balance Disorders, Knee Pain
What is being tested?
Hotpack, Ultrasound and Combine Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Jan 2018to 10 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hacettepe

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Diz Osteoartritinde Farklı Proprioseptif Nöromüsküler Fasilitasyon Tekniklerinin, Ağrı, Propriosepsiyon, Postural Kontrol, Kas Kuvveti, Eklem Hareket Açıklığı ve Diz Fonksiyonları Üzerine Olan Etkileri

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

Read the 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

Being tested
Hotpack, Ultrasound, Combine Exercise, Repeated Contraction Exercise, Standart Exercise Therapy
Medical subject headings
Muscle Weakness, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HotpackOther

    Hotpack applied 20 minutes for knee 3 session for 6 weeks

  • UltrasoundOther

    Ultrasound applied 10 minutes for knee 3 session for 6 weeks

  • Combine ExerciseOther

    Proprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week

  • Repeated Contraction ExerciseOther

    Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week

  • Standart Exercise TherapyOther

    Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise.

    3 session for 6 week

Study groups in NCT03615521
Study groupRoleWhat they receive
Repeated Contraction Exercise GroupExperimentalRepeated 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.
Receives: Other: Hotpack; Other: Ultrasound; Other: Repeated Contraction Exercise
Combine Exercise GroupExperimentalCombination 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.
Receives: Other: Hotpack; Other: Ultrasound; Other: Combine Exercise
Standart Exercise TherapyExperimentalClassic Physiotherapy: Hotpack, Ultrasound, Standart exercise program to improve Quadriceps, Hamstring and hip muscle strength. 3 session for 6 weeks.
Receives: Other: Hotpack; Other: Ultrasound; Other: Standart Exercise Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 week

Secondary outcomes (8)
  1. Knee Proprioception (30-45 and 60 degree)

    Proprioception is evaluated with Biodex System (30-45 and 60 degree)

    Measured: 6 week

  2. 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.

    Measured: 6 week

  3. Step test

    Climb and step in 10 steps. Brief time is better.

    Measured: 6 week

  4. 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.

    Measured: 6 week

  5. 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.

    Measured: 6 week

  6. 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.

    Measured: 6 week

  7. 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.

    Measured: 6 week

  8. 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.

    Measured: 6 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start20 Jan 2018
  3. Primary completion20 May 2021
  4. Study completion10 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615521
Sponsor's protocol ID
2017/09-36 (KA-17112)
Status last verified
Feb 2022
First submitted
11 Dec 2017
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hotpack, Ultrasound and Combine Exercise in people with Muscle Weakness and Balance Disorders, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quadriceps Femoris Muscle Strength (time frame: 6 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.

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