NCT06407414

Brief Summary

The aim of the study is to investigate the effects of a neuromuscular exercise program on strength, balance, sleep quality and functionality in individuals with Patellofemoral pain syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 14, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

May 6, 2024

Last Update Submit

September 11, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Kujala Patellofemoral Score Scale

    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.

    14 weeks

  • Lysholm Knee Scoring Scale

    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).

    14 weeks

  • International Physical Activity Survey

    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.

    14 weeks

  • Pittsburgh Sleep Quality Index

    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

    14 weeks

  • Y Balance Test

    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

  • 30 Second Sit and Stand Test

    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.

    14 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

classical physiotherapy methods

Other: control

exercise

EXPERIMENTAL

In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied.

Other: Exercise

Interventions

controlOTHER

classical physiotherapy methods

control

In addition to classical physiotherapy methods, neuromuscular exercise protocol will be applied.

exercise

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 34713770BACKGROUND
  • 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.

    PMID: 36395370BACKGROUND
  • 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.

    PMID: 32728976BACKGROUND
  • 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). 2016 May;34:22-9. doi: 10.1016/j.clinbiomech.2016.03.002. Epub 2016 Mar 11.

    PMID: 27054583BACKGROUND
  • 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.

    PMID: 29392329BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Büşra ARISÜT

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

May 14, 2024

Primary Completion

September 11, 2024

Study Completion

September 11, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations