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Star Excursion Balance for Patellofemoral Pain Syndrome (SEBT)

Primary Purpose

Patellofemoral Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Star excursion balance test
Kinesthetic Ability Trainer 2000
SEBT and KAT 2000
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Balance, Patellofemoral pain syndrome, Star excursion balance test, Kinesthetic Ability Trainer 2000

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ufuk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

SEBT exercise group

KAT 2000 exercise group

combined exercise group

Arm Description

Star Excursion Balance Test will be used

Kinesthetic ability trainer will be used

Both star Excursion Balance Test exercise and Kinesthetic ability trainer will be used.

Outcomes

Primary Outcome Measures

Berg Balance Scale
Berg Balance Scale

Secondary Outcome Measures

patient's global assessment
patient's global assessment
doctor's global assessment
doctor's global assessment
Western Ontario McMaster Osteoarthritis Index
Kujala Patellofemoral Score
Kujala Patellofemoral Score
Nottingham Health Profile
Nottingham Health Profile

Full Information

First Posted
October 24, 2017
Last Updated
January 15, 2018
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT03364855
Brief Title
Star Excursion Balance for Patellofemoral Pain Syndrome
Acronym
SEBT
Official Title
Effect of Star Excursion Balance Test on Balance, Quality of Life and Functional Status in Patients With Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
March 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Balance, Patellofemoral pain syndrome, Star excursion balance test, Kinesthetic Ability Trainer 2000

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEBT exercise group
Arm Type
Active Comparator
Arm Description
Star Excursion Balance Test will be used
Arm Title
KAT 2000 exercise group
Arm Type
Active Comparator
Arm Description
Kinesthetic ability trainer will be used
Arm Title
combined exercise group
Arm Type
Active Comparator
Arm Description
Both star Excursion Balance Test exercise and Kinesthetic ability trainer will be used.
Intervention Type
Other
Intervention Name(s)
Star excursion balance test
Intervention Description
Star excursion balance test,
Intervention Type
Other
Intervention Name(s)
Kinesthetic Ability Trainer 2000
Intervention Description
Kinesthetic Ability Trainer 2000
Intervention Type
Other
Intervention Name(s)
SEBT and KAT 2000
Intervention Description
Star excursion balance test and Kinesthetic Ability Trainer 2000
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
Berg Balance Scale
Time Frame
1 month
Secondary Outcome Measure Information:
Title
patient's global assessment
Description
patient's global assessment
Time Frame
1 month
Title
doctor's global assessment
Description
doctor's global assessment
Time Frame
1 month
Title
Western Ontario McMaster Osteoarthritis Index
Time Frame
1 months
Title
Kujala Patellofemoral Score
Description
Kujala Patellofemoral Score
Time Frame
1 month
Title
Nottingham Health Profile
Description
Nottingham Health Profile
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duygu Kerim
Phone
00903122044355
Email
duyguucar231@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ASLIHAN UZUNKULAOGLU
Organizational Affiliation
Ufuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saime AY
Organizational Affiliation
Ufuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Ufuk University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duygu Kerim
Email
duyguucar231@hotmail.com
Ext
UZUNKULAOGLU
Email
aslihanseyrek@gmail.com
First Name & Middle Initial & Last Name & Degree
ASLIHAN UZUNKULAOGLU
First Name & Middle Initial & Last Name & Degree
SAİME AY

12. IPD Sharing Statement

Plan to Share IPD
No

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Star Excursion Balance for Patellofemoral Pain Syndrome

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