Patellofemoral Pain SyndromeSEBTNCT03364855
Star Excursion Balance for Patellofemoral Pain Syndrome
A study testing Star excursion balance test, Kinesthetic Ability Trainer 2000 and SEBT and KAT 2000 in people with Patellofemoral Pain Syndrome, run by Ufuk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Star excursion balance test, Kinesthetic Ability Trainer 2000 and SEBT and KAT 2000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2018to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ufuk University
Ankara
Duygu Kerim, duyguucar231@hotmail.com
aslihanseyrek@gmail.com
About this study
Official title: Effect of Star Excursion Balance Test on Balance, Quality of Life and Functional Status in Patients With Patellofemoral Pain Syndrome
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.
Read the 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).
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Star excursion balance test, Kinesthetic Ability Trainer 2000, SEBT and KAT 2000
- Keywords
- Balance, Patellofemoral pain syndrome, Star excursion balance test, Kinesthetic Ability Trainer 2000
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Star excursion balance testOther
Star excursion balance test,
Kinesthetic Ability Trainer 2000Other
Kinesthetic Ability Trainer 2000
SEBT and KAT 2000Other
Star excursion balance test and Kinesthetic Ability Trainer 2000
| Study group | Role | What they receive |
|---|---|---|
| SEBT exercise group | Active comparator | Star Excursion Balance Test will be used Receives: Other: Star excursion balance test |
| KAT 2000 exercise group | Active comparator | Kinesthetic ability trainer will be used Receives: Other: Kinesthetic Ability Trainer 2000 |
| combined exercise group | Active comparator | Both star Excursion Balance Test exercise and Kinesthetic ability trainer will be used. Receives: Other: SEBT and KAT 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Berg Balance Scale
Measured: 1 month
Secondary outcomes (5)
patient's global assessment
patient's global assessment
Measured: 1 month
doctor's global assessment
doctor's global assessment
Measured: 1 month
Western Ontario McMaster Osteoarthritis Index
Measured: 1 months
Kujala Patellofemoral Score
Kujala Patellofemoral Score
Measured: 1 month
Nottingham Health Profile
Nottingham Health Profile
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start12 Jan 2018
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ufuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Kerim, Ufuk University
- Investigators
- ASLIHAN UZUNKULAOGLU, Study chair, Ufuk UniversitySaime AY, Study chair, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364855
- Sponsor's protocol ID
- 26022016-5
- Acronym
- SEBT
- Status last verified
- Jan 2018
- First submitted
- 24 Oct 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Star Excursion Balance Test on Balance, Quality of Life and Functional Status in Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT03364855
- Acronym / sponsor ID
- SEBT / 26022016-5
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Balance, Patellofemoral pain syndrome, Star excursion balance test, Kinesthetic Ability Trainer 2000
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ufuk UniversityUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SEBT exercise group | Active comparator | Other: Star excursion balance testStar Excursion Balance Test will be used |
| KAT 2000 exercise group | Active comparator | Other: Kinesthetic Ability Trainer 2000Kinesthetic ability trainer will be used |
| combined exercise group | Active comparator | Other: SEBT and KAT 2000Both star Excursion Balance Test exercise and Kinesthetic ability trainer will be used. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Effusion on patellefemoral site
- Severe neurologic disease
- Trauma history
- Lower extremity surgery history
- Lower extremity fracture history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Star excursion balance testStar excursion balance test, | Other | SEBT exercise group |
| Kinesthetic Ability Trainer 2000Kinesthetic Ability Trainer 2000 | Other | KAT 2000 exercise group |
| SEBT and KAT 2000Star excursion balance test and Kinesthetic Ability Trainer 2000 | Other | combined exercise group |
Primary outcome
Berg Balance Scale
Time frame: 1 month
Berg Balance Scale
5 secondary outcomes
patient's global assessment
Time frame: 1 month
doctor's global assessment
Time frame: 1 month
Western Ontario McMaster Osteoarthritis Index
Time frame: 1 months
Kujala Patellofemoral Score
Time frame: 1 month
Nottingham Health Profile
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ASLIHAN UZUNKULAOGLU study chair
Ufuk University
Saime AY study chair
Ufuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Star excursion balance test, Kinesthetic Ability Trainer 2000 and SEBT and KAT 2000 in people with Patellofemoral Pain Syndrome, run by Ufuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duygu Kerim (00903122044355, duyguucar231@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.