NCT06511362

Brief Summary

The main objective of this study is to determine the comparative effects of perturbation and functional stabilization training on pain, balance, and performance in athletes with patellofemoral pain syndrome(PFPS). Patellofemoral pain syndrome is one of the well known causes of anterior knee joint pain. Proximal and distal joint muscle imbalances are the most predisposing factors in knee pain especially knee cap. Anterior knee pain Increase during flexion of the knee, i.e., jumping, running, squatting and descending stairs. PFPS have a crucial impact on balance and functional activities, particularly for young athletes under the age 40. Individuals with PFPS manifest abnormalities in the dynamic and kinematic balance of the lower extremity. Participants between the age of 18-30 with knee pain and have difficulty performing the activities. Perturbation training is the part of the neuromuscular training program include the balancing activities that test the balance during the rehabilitation program. Functional stabilization training is used to improve the muscle control and strength. This particular program focuses on improving balance and determining the effect of training on prformance and balance of athletes with PFPS.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 15, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

June 11, 2024

Last Update Submit

July 15, 2024

Conditions

Keywords

Anterior knee pain syndrome

Outcome Measures

Primary Outcomes (6)

  • A numerical pain rating scale

    this numeric pain rating scale will use to assess the level of pain. This scale consist of values from 0 to 10. 0 represent to no pain where as 10 indicate to worst pain. Scale is subdivided into 3 level. Level 1 range from 0 to 3 interpret mild pain. Level 2 having range from 4 to 6 interpret individual has moderate pain and level 3 have value from 7 to 10 indicate the severe pain.

    10 months

  • horizontal jump test (meters)

    This test will be used to assess the performance of athletes. Participants must stand with their toes behind the zero-centimeter mark with the tape measure and jump as far as they can with two feet with swinging arms and bending knees. In this test, the participant must land a stick and measure the distance from the takeoff to the contact point after jumping. This scale is rated as excellent if a female athlete covers a distance \>1.91 meters; 1.90-1.71 meters indicates above average; 1.70-1.60 meters indicates average; distances between 1.59 and 1.47 meters indicate below average; and distances covered by the athlete \<1.47 meters represent poor distance or performance.

    10 months

  • vertical jumps tests(cm)

    Vertical jump test use to assess the performance of athlete(lower extremity strength). To perform this test athlete warm up for 10 minutes. Then, they perform this test by standing side onto the wall. Participants reach as high as possible with one hand mark as M1 after that they jump as high as possible, which mark as M2. Measure the distance between M1and M2. Distance measure in cm. The distance \>60 cm consider as excellent, between 46-60 cm consider as above average, between 31-45 cm consider as average, 21-30 cm consider as below average and distance \<20 cm consider as poor performance(strength)

    10 months

  • 40-yard sprint test (sec)

    This test is used to assess speed, agility, and quickness. In this test, mark a 40-yard distance on the floor. Athletes run from the starting point to the finishing point. The time in seconds was measured by using a stopwatch to cover the 40-yard (36.6-meter) distance.

    10 months

  • lower extremity functional scale

    This test is used as a performance assessment tool. This test consists of 20 questions relating to the person's ability to perform tasks related to daily life. A scoring system is available to predict the functional level. 0-20 scores represent severe functional limitations. 21-40 scores indicate moderate functional limitation; 41-60 scores show mild functional limitation; and 61-80 scores show minimum and no functional limitation.

    10 months

  • star excursion balance test(cm)

    The star excursion balance test (SEBT) is described as a tool to assess the dynamic balance. Draw a star shape with tape on the floor, separated by a 45-degree angle. It involves reaching in multiple directions, mostly eight, while maintaining balance on one leg. Anterior, anteromedial, lateral, anterolateral, medial, posteromedial, posterior, and posteromedial are the eight directions. Relative distance percentage in each direction is measured by using the formula average distance in one direction/leg length\*100. The average distance is measured by taking 3 readings of distance in each direction and dividing by 3.Reading must be done with both the right and left legs.

    10 months

Study Arms (2)

Functional stabilization training (Group 1))

EXPERIMENTAL

The participants will perform Lateral bridge and ventral bridge(6 weeks protocol,5 sets 30 sec, 5 sec hold of each rep), Isometric hip abduction/lateral rotation in standing (first 2 weeks 2 sets 20 reps), Hip abduction/lateral rotation/extension in sidelying ( 6 week 2 sets 20 reps), Hip abduction/lateral rotation with slight knee and hip flexion in sidelying ( 6 week , 2 sets , 20 reps), Pelvic drop in standing ( 6 weeks , 3 sets 12 reps ) Hip lateral rotation in closed kinetic chain ( 6 weeks, 3 sets , 12 reps ) Single-leg deadlift (6-8 weeks , 3 sets , 12 reps) Single-leg squat ( last 2 weeks ,3 sets 12 reps) Prone knee flexion (6 weeks 2-3 sets , 12 reps) Seated knee extension (90°-45° of knee flexion)( 6 weeks ,2-3 sets 12 reps ) Single-leg standing on unstable platform ( 3 sets)

Procedure: Functional stabilization training

Perturbation training(Group 2)

EXPERIMENTAL

Perform perturbation exercises that involve double leg foam balance activity (30-second hold), tilt board balance training (30-second hold), and roller board (30-second hold).

Procedure: perturbation exercises

Interventions

At the start of the study, a formal education session, lasting about 30 minutes will be given. whole treatment plan will be given for 8 weeks. Pre and post intervention measurements will be taken by using measuring tools.

Functional stabilization training (Group 1))

At the start of the study, a formal education session, lasting about 30 minutes will be given. whole treatment plan will be given for 8 weeks. Pre and post intervention measurements will be taken by using measuring tools.

Perturbation training(Group 2)

Eligibility Criteria

Age15 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale athlete between the age of 15-30, having with knee pain.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Anterior knee pain.
  • Age between 15 to 30.
  • Pain between 3 to 10 on NPRS.

You may not qualify if:

  • patellar fracture.
  • Intra-articular pathology( ligamental and meniscal injury of the knee).
  • Knee surgery
  • Fracture of hip, knee, shin bone and foot
  • Vestibular and visual disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan sports board

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Amna Shahid, T-DPT

    Riphah inernational university.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AISHA SIDDIQA, MS-DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

July 19, 2024

Study Start

February 15, 2023

Primary Completion

July 15, 2024

Study Completion

August 25, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

No plan to make IPD available to other researcher

Locations