Patellofemoral Pain SyndromeNCT05884710
Effectıveness of Foot Core Exercises on paın and functıonal Performance ın patıents wıth Patellofemoral paın Syndrome
A study testing Foot core exercises and Conventional Physiotherapy in people with Patellofemoral Pain Syndrome, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
30 participants wit Patellofemoral Pain Syndrome will be included in this study.Participants will be randomly divided and divided into 2 groups: The first group contains; quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and the second group… Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Foot core exercises and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Jul 2023
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- İnclusion criterias are volunteering to participate in research,participants between 20-59 years old with PFPS will be included if they had anterior knee pain during at least 2 funtional activities including step-up and step-down, squatting,kneeling,jumping or running of at least 1 months' duration,individuals who are active for 30 minutes almost every day of the week,individuals who has with chondromalacia patella grade 1-2-3 and lateral patellar compression syndrome
Who cannot join
- Exclusion criterias are acute musculoskeletal injury affecting the lower extremity in the last 4 months,having a balance or vestibular disorder,low quality of life,limited lower extremity movements.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe University
Istanbul, İnönü Mah. Kayışdağı Cad. 326a. 26 Ağustos Yerleşimi, 34755
Zeynep Budak, 05350138233, zeynep.budak@std.yeditepe.edu.tr
About this study
30 participants wit Patellofemoral Pain Syndrome will be included in this study.Participants will be randomly divided and divided into 2 groups: The first group contains; quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and the second group contains:quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and foot core exercıses (short foot exercise, towel curls, toe spread and squeeze, balance board training).
Read the detailed description
This study will be carried out in Mersin Medikalpark Hospital and this research planned as a prospective, randomized controlled trial.30 participants with Patellofemoral Pain Syndrome (PFPS) will be included in this study.Some inclusion and exclusion criterias were determined for our study.İnclusion criterias are volunteering to participate in research,participants between 20-59 years old with PFPS will be included if they had anterior knee pain during at least 2 funtional activities including step-up and step-down, squatting,kneeling,jumping or running of at least 1 months' duration,individuals who are active for 30 minutes almost every day of the week,individuals who has with chondromalacia patella grade 1-2-3 and lateral patellar compression syndrome.Exclusion criterias are acute musculoskeletal injury affecting the lower extremity in the last 4 months, having a balance or vestibular disorder,low quality of life,limited lower extremity movements.Participants will be randomly divided and divided into 2 groups: The first group contains; quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and the second group contains:quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and foot core exercıses (short foot exercise, towel curls, toe spread and squeeze, balance board training).Some measurement parameters will be used in this study. VAS scale will be used to assess pain.10 meter walk test,timed up and go test, stair climb test and Internatıonal Physical Actıvıty Questionnaire(IPAQ) will be used to assess functional performance.Knee and ankle muscle test and range of motions will assessed and quality of life will evaluated with SF-36 short form scale.All measurements will be made again after 6 weeks.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Foot core exercises, Conventional Physiotherapy
- 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.
Foot core exercisesOther
2 groups; First group is an intervention group who has contain foot core exercises and the other group is a control group.
Conventional PhysiotherapyOther
Electrotherapeutic modalities and range of motion exercises
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Foot core exercises consist of 4 movements; short foot exercise, towel curls, toe spread and squeeze, balance board training Receives: Other: Foot core exercises; Other: Conventional Physiotherapy |
| Control Group | Active comparator | Conventional Physiotherapy Program Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The scale called VAS will be used for pain assessment. Patirnt will select the number between 0 and 10. While 0 means no pain, 10 means worst pain.
Measured: 6 weeks
10 meter walk test
Walking test for assess functional performance
Measured: 6 weeks
Timed up and go test
Walking test for assess functional performance
Measured: 6 weeks
Stair climb test
Step in and out for assess functional performance
Measured: 6 weeks
International Physical Activity Questionnaire
This is a scale for functional performance
Measured: 6 weeks
Secondary outcomes (2)
SF-36 short form
Quality of life
Measured: 6 weeks
Knee and ankle ROM
Knee and ankle range of motion values
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2023
- Primary completion15 Jul 2023
- Study completion30 Jul 2023 (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
- Model description
- Participants with Patellofemoral Pain Syndrome (PFPS) will be randomly divided into 2 groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884710
- Sponsor's protocol ID
- 777
- Status last verified
- Jul 2023
- First submitted
- 9 May 2023
- Last updated
- 8 Aug 2023
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectıveness of Foot Core Exercises on paın and functıonal Performance ın patıents wıth Patellofemoral paın Syndrome
- ClinicalTrials.gov ID
- NCT05884710
- Acronym / sponsor ID
- 777
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
30 participants wit Patellofemoral Pain Syndrome will be included in this study.Participants will be randomly divided and divided into 2 groups: The first group contains; quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and the second group contains:quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and foot core exercıses (short foot exercise, towel curls, toe spread and squeeze, balance board training).
Detailed description
This study will be carried out in Mersin Medikalpark Hospital and this research planned as a prospective, randomized controlled trial.30 participants with Patellofemoral Pain Syndrome (PFPS) will be included in this study.Some inclusion and exclusion criterias were determined for our study.İnclusion criterias are volunteering to participate in research,participants between 20-59 years old with PFPS will be included if they had anterior knee pain during at least 2 funtional activities including step-up and step-down, squatting,kneeling,jumping or running of at least 1 months' duration,individuals who are active for 30 minutes almost every day of the week,individuals who has with chondromalacia patella grade 1-2-3 and lateral patellar compression syndrome.Exclusion criterias are acute musculoskeletal injury affecting the lower extremity in the last 4 months, having a balance or vestibular disorder,low quality of life,limited lower extremity movements.Participants will be randomly divided and divided into 2 groups: The first group contains; quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and the second group contains:quadrıceps ısometrıc exercıses ın supıne posıtıon, NMES electrıcal current, soft tıssue therapy-patellar mobılısatıon and foot core exercıses (short foot exercise, towel curls, toe spread and squeeze, balance board training).Some measurement parameters will be used in this study. VAS scale will be used to assess pain.10 meter walk test,timed up and go test, stair climb test and Internatıonal Physical Actıvıty Questionnaire(IPAQ) will be used to assess functional performance.Knee and ankle muscle test and range of motions will assessed and quality of life will evaluated with SF-36 short form scale.All measurements will be made again after 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants with Patellofemoral Pain Syndrome (PFPS) will be randomly divided into 2 groups.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Foot core exercises, Other: Conventional PhysiotherapyFoot core exercises consist of 4 movements; short foot exercise, towel curls, toe spread and squeeze, balance board training |
| Control Group | Active comparator | Other: Conventional PhysiotherapyConventional Physiotherapy Program |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- İnclusion criterias are volunteering to participate in research,participants between 20-59 years old with PFPS will be included if they had anterior knee pain during at least 2 funtional activities including step-up and step-down, squatting,kneeling,jumping or running of at least 1 months' duration,individuals who are active for 30 minutes almost every day of the week,individuals who has with chondromalacia patella grade 1-2-3 and lateral patellar compression syndrome
Key exclusion criteria (1 listed)
- Exclusion criterias are acute musculoskeletal injury affecting the lower extremity in the last 4 months,having a balance or vestibular disorder,low quality of life,limited lower extremity movements.
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 |
|---|---|---|
| Foot core exercises2 groups; First group is an intervention group who has contain foot core exercises and the other group is a control group. | Other | Exercise Group |
| Conventional PhysiotherapyElectrotherapeutic modalities and range of motion exercises | Other | Control Group, Exercise Group |
Primary outcome
Visual Analog Scale
Time frame: 6 weeks
The scale called VAS will be used for pain assessment. Patirnt will select the number between 0 and 10. While 0 means no pain, 10 means worst pain.
10 meter walk test
Time frame: 6 weeks
Walking test for assess functional performance
Timed up and go test
Time frame: 6 weeks
Walking test for assess functional performance
Stair climb test
Time frame: 6 weeks
Step in and out for assess functional performance
International Physical Activity Questionnaire
Time frame: 6 weeks
This is a scale for functional performance
2 secondary outcomes
SF-36 short form
Time frame: 6 weeks
Knee and ankle ROM
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot core exercises and Conventional Physiotherapy in people with Patellofemoral Pain Syndrome, run by Yeditepe 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 1 inclusion and 1 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 8 Aug 2023. 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 Zeynep BUDAK (05350138233 ext. 535, zeynep.budak@std.yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 6 weeks). The study lists 5 primary outcomes in all. 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 8 Aug 2023.