- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05884710
Effectıveness of Foot Core Exercises on paın and functıonal Performance ın patıents wıth Patellofemoral paın Syndrome
August 5, 2023 updated by: Yeditepe University
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeynep BUDAK
- Phone Number: 535 05350138233
- Email: zeynep.budak@std.yeditepe.edu.tr
Study Contact Backup
- Name: Elif DEVELİ
- Phone Number: 555 05555936293
- Email: elif.ustun@yeditepe.edu.tr
Study Locations
-
-
İnönü Mah. Kayışdağı Cad. 326a. 26 Ağustos Yerleşimi
-
Istanbul, İnönü Mah. Kayışdağı Cad. 326a. 26 Ağustos Yerleşimi, Turkey, 34755
- Recruiting
- Yeditepe University
-
Contact:
- Zeynep Budak
- Phone Number: 05350138233
- Email: zeynep.budak@std.yeditepe.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise Group
Foot core exercises consist of 4 movements; short foot exercise, towel curls, toe spread and squeeze, balance board training
|
2 groups; First group is an intervention group who has contain foot core exercises and the other group is a control group.
Electrotherapeutic modalities and range of motion exercises
|
|
Active Comparator: Control Group
Conventional Physiotherapy Program
|
Electrotherapeutic modalities and range of motion exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks
|
|
10 meter walk test
Time Frame: 6 weeks
|
Walking test for assess functional performance
|
6 weeks
|
|
Timed up and go test
Time Frame: 6 weeks
|
Walking test for assess functional performance
|
6 weeks
|
|
Stair climb test
Time Frame: 6 weeks
|
Step in and out for assess functional performance
|
6 weeks
|
|
International Physical Activity Questionnaire
Time Frame: 6 weeks
|
This is a scale for functional performance
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SF-36 short form
Time Frame: 6 weeks
|
Quality of life
|
6 weeks
|
|
Knee and ankle ROM
Time Frame: 6 weeks
|
Knee and ankle range of motion values
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
July 15, 2023
Study Completion (Estimated)
July 30, 2023
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
May 31, 2023
First Posted (Actual)
June 1, 2023
Study Record Updates
Last Update Posted (Actual)
August 8, 2023
Last Update Submitted That Met QC Criteria
August 5, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 777
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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