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Star Excursion Balance for Patellofemoral Pain Syndrome (SEBT)

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ClinicalTrials.gov Identifier: NCT03364855
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Duygu Kerim, Ufuk University

Brief Summary:
Patellofemoral pain syndrome (PFPS) is a common and painful musculoskeletal condition that affects physically active young adults and causes pain front of the knee. Patients with PFPS has bilateral impairment in proprioception, as well as more in the affected knee than the normal; also the decrease of muscular strength, range of motion, and neuromuscular control are known to result with impaired static and dynamic balance.This study aimed to investigate the efficacy of a-four week YDT balance exercises on pain, quality of life and functional state in patients with PFPS with impaired balance.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Star excursion balance test Other: Kinesthetic Ability Trainer 2000 Other: SEBT and KAT 2000 Not Applicable

Detailed Description:

Patellofemoral pain syndrome (PFPS) is a common and painful musculoskeletal condition that affects physically active young adults and causes pain front of the knee. Patients with PFPS has bilateral impairment in proprioception, as well as more in the affected knee than the normal; also the decrease of muscular strength, range of motion, and neuromuscular control are known to result with impaired static and dynamic balance. We aimed to investigate the efficacy of a-four week YDT balance exercises on pain, quality of life and functional state in patients with PFPS with impaired balance.

Patients with PFPS diagnosed will included in the study. Participants will randomized into the YDT exercise group (n = 24), the KAT 2000 exercise group (n = 24) and the combined exercise group (n = 24). Before the study, all groups of patients will given exercises such as quadriceps, vastus medialis oblique (VMO), hip abductor, extensor and external rotator strengthening exercises. All patient groups received balance training for four weeks, three days a week.

Pain intensity will be measure on Visual Analog Scale (VAS). Functional capacity will be evaluated by using the Western Ontario McMaster Osteoarthritis Index (WOMAC) and Kujala Patellofemoral Score (KPS). Static balance performance will be evaluated by using Kinesthetic Ability Trainer 2000 (KAT 2000) and dynamic balance performance will be evaluated by using Berg Balance Scale (BBS) and KAT 2000. The quality of life will assessed using Nottingham Health Profile (NHP).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Star Excursion Balance Test on Balance, Quality of Life and Functional Status in Patients With Patellofemoral Pain Syndrome
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : March 1, 2018

Arm Intervention/treatment
Active Comparator: SEBT exercise group
Star Excursion Balance Test will be used
Other: Star excursion balance test
Star excursion balance test,

Active Comparator: KAT 2000 exercise group
Kinesthetic ability trainer will be used
Other: Kinesthetic Ability Trainer 2000
Kinesthetic Ability Trainer 2000

Active Comparator: combined exercise group
Both star Excursion Balance Test exercise and Kinesthetic ability trainer will be used.
Other: SEBT and KAT 2000
Star excursion balance test and Kinesthetic Ability Trainer 2000




Primary Outcome Measures :
  1. Berg Balance Scale [ Time Frame: 1 month ]
    Berg Balance Scale


Secondary Outcome Measures :
  1. patient's global assessment [ Time Frame: 1 month ]
    patient's global assessment

  2. doctor's global assessment [ Time Frame: 1 month ]
    doctor's global assessment

  3. Western Ontario McMaster Osteoarthritis Index [ Time Frame: 1 months ]
  4. Kujala Patellofemoral Score [ Time Frame: 1 month ]
    Kujala Patellofemoral Score

  5. Nottingham Health Profile [ Time Frame: 1 month ]
    Nottingham Health Profile



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 20 -50 years
  • Retropatellar pain
  • Positive Clark test, J finding, increased Q angle, positive patellar compression and comphrension test
  • Mild or moderate Berg Balance Scale Scores
  • body mass index <30
  • Mini mental state test score >24

Exclusion Criteria:

  • Effusion on patellefemoral site
  • Severe neurologic disease
  • Trauma history
  • Lower extremity surgery history
  • Lower extremity fracture history
  • severe vitamin B12 deficiency
  • another disease led to balance deficit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364855


Contacts
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Contact: Duygu Kerim 00903122044355 duyguucar231@hotmail.com

Locations
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Turkey
Ufuk University Recruiting
Ankara, Turkey
Contact: Duygu Kerim       duyguucar231@hotmail.com   
Contact       aslihanseyrek@gmail.com   
Sub-Investigator: ASLIHAN UZUNKULAOGLU         
Sub-Investigator: SAİME AY         
Sponsors and Collaborators
Ufuk University
Investigators
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Study Chair: ASLIHAN UZUNKULAOGLU Ufuk University
Study Chair: Saime AY Ufuk University

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Responsible Party: Duygu Kerim, Ufuk University
ClinicalTrials.gov Identifier: NCT03364855     History of Changes
Other Study ID Numbers: 26022016-5
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duygu Kerim, Ufuk University:
Balance
Patellofemoral pain syndrome
Star excursion balance test
Kinesthetic Ability Trainer 2000
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases