- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03364855
Star Excursion Balance for Patellofemoral Pain Syndrome (SEBT)
Effect of Star Excursion Balance Test on Balance, Quality of Life and Functional Status in Patients With Patellofemoral Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Duygu Kerim
- Phone Number: 00903122044355
- Email: duyguucar231@hotmail.com
Study Locations
-
-
-
Ankara, Turkey
- Recruiting
- Ufuk University
-
Contact:
- Duygu Kerim
- Email: duyguucar231@hotmail.com
-
Contact:
- Email: aslihanseyrek@gmail.com
-
Sub-Investigator:
- ASLIHAN UZUNKULAOGLU
-
Sub-Investigator:
- SAİME AY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SEBT exercise group
Star Excursion Balance Test will be used
|
Star excursion balance test,
|
Active Comparator: KAT 2000 exercise group
Kinesthetic ability trainer will be used
|
Kinesthetic Ability Trainer 2000
|
Active Comparator: combined exercise group
Both star Excursion Balance Test exercise and Kinesthetic ability trainer will be used.
|
Star excursion balance test and Kinesthetic Ability Trainer 2000
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale
Time Frame: 1 month
|
Berg Balance Scale
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient's global assessment
Time Frame: 1 month
|
patient's global assessment
|
1 month
|
doctor's global assessment
Time Frame: 1 month
|
doctor's global assessment
|
1 month
|
Western Ontario McMaster Osteoarthritis Index
Time Frame: 1 months
|
1 months
|
|
Kujala Patellofemoral Score
Time Frame: 1 month
|
Kujala Patellofemoral Score
|
1 month
|
Nottingham Health Profile
Time Frame: 1 month
|
Nottingham Health Profile
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ASLIHAN UZUNKULAOGLU, Ufuk University
- Study Chair: Saime AY, Ufuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26022016-5
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
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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