- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407414
Effectiveness of Neuromuscular Exercise in Patellofemoral Pain Syndrome
The Effect of Neuromuscular Exercise Program on Strength, Balance, Sleep Quality and Functionality in Patellofemoral Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Uskudar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Volunteering to participate in the study.
- Not under 30 years of age and not over 60 years of age.
- Having patellofemoral pain syndrome.
- Not having a physical disability.
- Not having undergone any knee-related surgery.
- Having access to a computer/tablet/phone and the internet.
Exclusion Criteria:
- Not accepting the voluntary consent form.
- Being under 30 years of age and over 60 years of age.
- Having undergone any knee-related surgery.
- Having cognitive, mental or psychological problems.
- Having impaired vision or hearing.
- Having a physical condition that causes significant loss of function.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: control
classical physiotherapy methods
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classical physiotherapy methods
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Experimental: exercise
In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied.
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In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lysholm Knee Scoring Scale
Time Frame: 14 weeks
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The Lysholm knee scoring scale is a global assessment tool that reflects overall functional outcome and physical activity level.
The Lysholm scale is an 8-item questionnaire originally designed to assess knee function after knee ligament injuries.
It was later confirmed for other knee conditions.
Items evaluated according to the Lysholm scale include pain, type of support, instability, locking, swelling, limping, climbing stairs, and squatting.
All items are scored to yield a score of 1, ranging from 0 to 100, with a higher Lysholm score indicating a lower level of symptoms and a higher level of functioning (91-100 = excellent, 84-90 = good, 65-83 = fair).
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14 weeks
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30 Second Sit and Stand Test
Time Frame: 14 weeks
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It is a test that evaluates the patient's sitting and standing activity, lower extremity strength and dynamic balance.
The number of times the patient sits and stands within 30 seconds gives the score of the test.
For this test performed to determine leg strength; A straight-backed chair with a seating height of 43.18cm (12-in) and no armrests is used.
The individual is asked to sit in the middle of the chair with his back upright, his feet on the ground, and his arms crossed in front of his chest (right hand on the left shoulder, left hand on the right shoulder).
While in this position, the individual starts the test with the start command and takes off as fully as he can during 30 seconds.
The number of complete starts he makes during 30 seconds constitutes the subject's score.
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14 weeks
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International Physical Activity Survey
Time Frame: 14 weeks
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Provides information on time spent walking, moderate and vigorous activities, and time spent sitting.
Calculation of the total score of the short form includes the sum of the duration (minutes) and frequency (days) of walking, moderate-intensity activity, and vigorous activity.
The energy required for activities is calculated with the metabolic equivalent(MET) -minute score.
Standard metabolic equivalent (MET) values have been established for these activities.
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14 weeks
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Pittsburgh Sleep Quality Index
Time Frame: 14 weeks
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The pittsburgh Sleep Quality Index is a quantitative measure of sleep quality to define good and bad sleep.
It includes 24 questions in total.
The self-assessment questions include various items related to sleep quality.
The total score is between 0-21.
A high total score indicates poor sleep quality.
The index does not indicate the presence of sleep disturbances or the prevalence of sleep disturbances.
However, a pittsburgh Sleep Quality Index total score of five or more indicates poor sleep quality
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14 weeks
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Y Balance Test
Time Frame: 14 weeks
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Y balance test is a simple but reliable test used to measure dynamic balance. The Y balance test is a dynamic test performed in a one-legged stance that requires strength, flexibility, core control and proprioception. It has been used to evaluate physical performance, demonstrate functional symmetry, and identify athletes at higher risk for lower extremity injury. With the test complete and all performances recorded, the test administrator can then calculate the athlete's Y Balance Test performance scores using any of, or all of, the following three equations: Absolute reach distance (cm) = (Reach 1 + Reach 2 + Reach 3) / 3 Relative (normalised) reach distance (%) = Absolute reach distance / limb length * 100 Composite reach distance (%) = Sum of the 3 reach directions / 3 times the limb length * 100 |
14 weeks
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Kujala Patellofemoral Score Scale
Time Frame: 14 weeks
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Kujala patellofemoral scoring is a tool that allows functional evaluation of knee complaints related to the patellofemoral structure.
Different scoring systems have been developed for knee-specific symptoms; however, only a few of these are focused on patellofemoral pain.The Kujala Patellofemoral Score Scale is graded on a scale of 0 to 100, with 100 being the highest possible score.
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14 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Büşra ARISÜT, Uskudar University
Publications and helpful links
General Publications
- Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
- Basbug P, Kilic RT, Atay AO, Bayrakci Tunay V. The effects of progressive neuromuscular exercise program and taping on muscle strength and pain in patellofemoral pain. A randomized controlled blind study. Somatosens Mot Res. 2022 Mar;39(1):39-45. doi: 10.1080/08990220.2021.1987877. Epub 2021 Oct 29.
- Kim S, Roh Y, Glaviano NR, Park J. Quadriceps Neuromuscular Function During and After Exercise-Induced Fatigue in Patients With Patellofemoral Pain. J Athl Train. 2023 Jun 1;58(6):554-562. doi: 10.4085/1062-6050-0348.22.
- Kolle T, Alt W, Wagner D. Effects of a 12-week home exercise therapy program on pain and neuromuscular activity in patients with patellofemoral pain syndrome. Arch Orthop Trauma Surg. 2020 Dec;140(12):1985-1992. doi: 10.1007/s00402-020-03543-y. Epub 2020 Jul 29.
- Rathleff MS, Samani A, Olesen JL, Roos EM, Rasmussen S, Madeleine P. Effect of exercise therapy on neuromuscular activity and knee strength in female adolescents with patellofemoral pain-An ancillary analysis of a cluster randomized trial. Clin Biomech (Bristol, Avon). 2016 May;34:22-9. doi: 10.1016/j.clinbiomech.2016.03.002. Epub 2016 Mar 11.
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
- Uskudar8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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