- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06696872
Enhancing Stability and Function in Adolescent
November 19, 2024 updated by: Amira Hussin Hussin Mohammed, Delta University for Science and Technology
Proprioceptive Neuromuscular Facilitation Versus Core Training for Enhancing Stability and Function in Adolescent With Patellofemoral Pain Syndrome
This study investigated the comparative effects of proprioceptive neuromuscular facilitation (PNF) stretching and core strength exercises on static balance in adolescents with patellofemoral pain syndrome (PFPS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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 Locations
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Gamasa, Egypt, 35712
- Amira Hussin Mohammed
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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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants were between 16 and 18 years old.
- Patients had to have experienced anterior knee pain for at least 4 weeks, with the pain being exacerbated by at least two of the following activities: jumping, running, prolonged sitting, stair climbing, kneeling, and squatting (Chevidikunnan et al., 2016).
- Participants could not have undergone any surgical procedures on their lower limbs.
- Pain during the previous week needed to be greater than 30 mm on a 100 mm visual analogue scale (VAS) (Appendix I) (Rathleff et al., 2015).
- A spectrum of BMI was sought, with participants recruited to represent normal BMI percentile categories for both boys and girls. The normal BMI percentile categories for both boys and girls were defined as the 5th percentile to less than the 85th percentile (Appendix II) (King et al., 2012).
Exclusion Criteria:
Adolescents with cruciate ligament injuries, meniscal injuries, collateral ligament injuries, and tenderness associated with any of these structures, any intra-articular injury, and tenderness over the iliotibial band, patellar tendon, pes anserine tendons, or evidence of joint effusion.
- Adolescents with referred pain from the hip or lumbar region, or a known case of articular cartilage damage.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Core exercises
The participants were taught how to contract their deep abdominal muscles to obtain core muscle activation.
The patient should be contracting the abdominal muscles, lifting her lower belly up away from pubic bone, while breathing slowly and normally.
The patient should not hold her breath
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The core muscle strength training program were lasted for 8 weeks and comprised of 3 training sessions per week, with a total of 24 sessions.
Each session were lasted for 30 to 45 minutes, starting with a brief warm-up exercise program consisting of low-intensity core strength exercises to prepare the neuromuscular system for the training loads and ending with a cool-down program
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Experimental: Proprioceptive Neuromuscular Facilitation
The hold-relax proprioceptive neuromuscular facilitation stretching protocol consisted of passively moving the dominant leg into a position where the subjects felt mild discomfort and holding that position for 30 seconds.
Subjects were then asked to isometrically contract the stretched muscle for 10 seconds; this were followed by muscle relaxation in the same position for 30 seconds, before being stretched to a new point of mild discomfort.
The leg were then released
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The hold-relax proprioceptive neuromuscular facilitation stretching protocol consisted of passively moving the dominant leg into a position where the subjects felt mild discomfort and holding that position for 30 seconds.
Subjects were then asked to isometrically contract the stretched muscle for 10 seconds; this were followed by muscle relaxation in the same posi¬tion for 30 seconds, before being stretched to a new point of mild discomfort.
The leg were then released
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual analogue scale (VAS-100 mm) for pain
Time Frame: All adolescents were assessed before and after the 8-week intervention period
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All adolescents were assessed before and after the 8-week intervention period
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Dynamic postural stability test and single leg test using the Biodex Balance System SD
Time Frame: All adolescents were assessed before and after the 8-week intervention period
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All adolescents were assessed before and after the 8-week intervention period
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Self-administered Anterior Knee Pain Scale (AKPS) or Kujala Patellofemoral Score
Time Frame: All adolescents were assessed before and after the 8-week intervention period
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All adolescents were assessed before and after the 8-week intervention period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amira H Mohammed, PHD, Delta University for Science and Technology
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)
April 20, 2024
Primary Completion (Actual)
July 12, 2024
Study Completion (Actual)
July 12, 2024
Study Registration Dates
First Submitted
November 19, 2024
First Submitted That Met QC Criteria
November 19, 2024
First Posted (Estimated)
November 20, 2024
Study Record Updates
Last Update Posted (Estimated)
November 20, 2024
Last Update Submitted That Met QC Criteria
November 19, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Patellofemoral Pain syndrome
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
data availability by requesting from the corresponding author and after publication
IPD Sharing Time Frame
after 12 months from November 2024
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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