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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05884710
Other study ID # 777
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date July 30, 2023

Study information

Verified date July 2023
Source Yeditepe University
Contact Zeynep BUDAK
Phone 05350138233
Email zeynep.budak@std.yeditepe.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 30, 2023
Est. primary completion date July 15, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 59 Years
Eligibility Inclusion Criteria: - Inclusion 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 Design


Intervention

Other:
Foot core exercises
2 groups; First group is an intervention group who has contain foot core exercises and the other group is a control group.
Conventional Physiotherapy
Electrotherapeutic modalities and range of motion exercises

Locations

Country Name City State
Turkey Yeditepe University Istanbul Inönü Mah. Kayisdagi Cad. 326a. 26 Agustos Yerlesimi

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 weeks
Primary 10 meter walk test Walking test for assess functional performance 6 weeks
Primary Timed up and go test Walking test for assess functional performance 6 weeks
Primary Stair climb test Step in and out for assess functional performance 6 weeks
Primary International Physical Activity Questionnaire This is a scale for functional performance 6 weeks
Secondary SF-36 short form Quality of life 6 weeks
Secondary Knee and ankle ROM Knee and ankle range of motion values 6 weeks
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