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).
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.
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
- Conditions
- Muscle Weakness, Balance Disorders, Knee Pain, 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 group | Role | What they receive |
|---|---|---|
| Repeated Contraction Exercise Group | Experimental | 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. Receives: Other: Hotpack; Other: Ultrasound; Other: Repeated Contraction Exercise |
| Combine Exercise Group | Experimental | 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. Receives: Other: Hotpack; Other: Ultrasound; Other: Combine Exercise |
| Standart Exercise Therapy | Experimental | Classic 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.
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)
Knee Proprioception (30-45 and 60 degree)
Proprioception is evaluated with Biodex System (30-45 and 60 degree)
Measured: 6 week
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
Step test
Climb and step in 10 steps. Brief time is better.
Measured: 6 week
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
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
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
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
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.
- First posted6 Aug 2018
- Study start20 Jan 2018
- Primary completion20 May 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Gökşen, Karamanoğlu Mehmetbey University
- Investigators
- Filiz Can, Prof., Study director, Hacettepe University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diz Osteoartritinde Farklı Proprioseptif Nöromüsküler Fasilitasyon Tekniklerinin, Ağrı, Propriosepsiyon, Postural Kontrol, Kas Kuvveti, Eklem Hareket Açıklığı ve Diz Fonksiyonları Üzerine Olan Etkileri
- ClinicalTrials.gov ID
- NCT03615521
- Acronym / sponsor ID
- 2017/09-36 (KA-17112)
- Conditions
- Muscle Weakness, Balance Disorders, Knee Pain, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Repeated Contraction Exercise Group | Experimental | Other: Hotpack, Other: Ultrasound, Other: Repeated Contraction ExerciseRepeated 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. |
| Combine Exercise Group | Experimental | Other: Hotpack, Other: Ultrasound, Other: Combine ExerciseCombination 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. |
| Standart Exercise Therapy | Experimental | Other: Hotpack, Other: Ultrasound, Other: Standart Exercise TherapyClassic Physiotherapy: Hotpack, Ultrasound, Standart exercise program to improve Quadriceps, Hamstring and hip muscle strength. 3 session for 6 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HotpackHotpack applied 20 minutes for knee 3 session for 6 weeks | Other | Combine Exercise Group, Repeated Contraction Exercise Group, Standart Exercise Therapy |
| UltrasoundUltrasound applied 10 minutes for knee 3 session for 6 weeks | Other | Combine Exercise Group, Repeated Contraction Exercise Group, Standart Exercise Therapy |
| Combine ExerciseProprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week | Other | Combine Exercise Group |
| Repeated Contraction ExerciseProprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week | Other | Repeated Contraction Exercise Group |
| Standart Exercise TherapyQuadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise. 3 session for 6 week | Other | Standart Exercise Therapy |
Primary outcome
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.
8 secondary outcomes
Knee Proprioception (30-45 and 60 degree)
Time frame: 6 week
KOOS score
Time frame: 6 week
Step test
Time frame: 6 week
Womac Score
Time frame: 6 week
6 Minute walking test
Time frame: 6 week
Balance
Time frame: 6 week
Knee Pain Severity
Time frame: 6 week
Algometer
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filiz Can, Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
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.