NCT06696872

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 19, 2024

Last Update Submit

November 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual analogue scale (VAS-100 mm) for pain

    All adolescents were assessed before and after the 8-week intervention period

  • Dynamic postural stability test and single leg test using the Biodex Balance System SD

    All adolescents were assessed before and after the 8-week intervention period

Secondary Outcomes (1)

  • Self-administered Anterior Knee Pain Scale (AKPS) or Kujala Patellofemoral Score

    All adolescents were assessed before and after the 8-week intervention period

Study Arms (2)

Core exercises

EXPERIMENTAL

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

Other: core exercises

Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

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

Other: Proprioceptive Neuromuscular Facilitation

Interventions

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

Core exercises

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

Proprioceptive Neuromuscular Facilitation

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Hussin Mohammed

Gamasa, 35712, Egypt

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Amira H Mohammed, PHD

    Delta University for Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 20, 2024

Study Start

April 20, 2024

Primary Completion

July 12, 2024

Study Completion

July 12, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

data availability by requesting from the corresponding author and after publication

Time Frame
after 12 months from November 2024

Locations