NCT05917080

Brief Summary

The goal of this clinical trial\] is to To find out the effect of Neuromuscular Training and Manual therapy with Augmented Low - Dye Taping technique for correction of Pronated foot in the management of Anterior knee pain patients. The main question\[s\] it aims to answer are:

  • Is there any Kinematic association of biomechanical risk factors between anterior knee pain \& pronated foot?
  • Is there any potential impact of therapeutic foot interventions for correction of Pronated foot in the management of anterior knee pain?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 15, 2023

Last Update Submit

June 23, 2023

Conditions

Keywords

Anterior Knee painPronated footManual therapyNeuro muscular exerciselow dye tapingFoot Posture indexNumerical pain rating scaledynamic Knee valgus angleKujala Scale

Outcome Measures

Primary Outcomes (4)

  • AKPS (Kujala Scale)

    Anterior knee pain scale - measuring Functional Limitations, The AKPS contains 13 items self reported questionnaires. The AKPS graded on Scale of "0 to 100" with 100 being the highest possible score. lower scores reflect the greater pain \& disability.

    6 months

  • FPI

    Foot Posture index - Analyzing the Foot posture - The FPI-6 is a novel method of rating foot posture using set criteria and a simple scale, and is a quick, reliable diagnostic tool. neutral foot posture are graded as zero, while Pronated postures are given a positive value, the higher the value the more pronated. For a neutral foot the final FPI aggregate score should lie somewhere around zero.

    6 months

  • NPRS

    Numerical Pain rating Scale-Measuring the pain. The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    6 months

  • DVI

    Dynamic Valgus Index -Measuring the Dynamic knee valgus angulation. Two dimensional motion analysis of lower extremity movement typically focuses on the knee frontal plane projection angle, which considers the position of the femur and the tibia. A measure that includes the pelvis may provide a more comprehensive and accurate indicator of lower extremity movement. Dynamic knee valgus two-dimensional angular measures. 1a. Hip frontal plane projection angle, calculated as 90 ° minus the angle (α) between the pelvis segment and the thigh segment. Knee frontal plane projection angle, calculated as 180 ° minus the angle (β) between the thigh segment and the shank segment. 1b. Example of individual demonstrating an observable dynamic knee valgus, resulting in increased hip and knee frontal plane projection angles and a larger dynamic valgus index.

    6 months

Study Arms (3)

Group A (Experimental Group)

EXPERIMENTAL

Manual Therapy Technique Anti-Pronation Low- Dye Taping Technique Intrinsic Foot Muscles Exercises Calf Muscle \& Plantar Fascia Stretching VMO Strengthening

Other: Manual Therapy

Group B (Experimental Group)

EXPERIMENTAL

Neuromuscular Training Anti-Pronation Low- Dye Taping Technique Intrinsic Foot Muscles Exercises Calf Muscle \& Plantar Fascia Stretching VMO Strengthening

Other: Manual Therapy

Group C (Control Group)

OTHER

Intrinsic Foot Muscles Exercises Calf Muscle \& Plantar Fascia Stretching VMO Strengthening

Other: Manual Therapy

Interventions

Manual Therapy: Manual therapy is the use of hands-on techniques to evaluate, treat, and improve the status of Neuro-musculoskeletal conditions. Augmented Low-Dye Taping: Augmented Low-Dye taping is designed to off-load the plantar fascia \& applied below the ankle and is hypothesised to generate a supinating force that controls the amount of pronation at the subtalar joint. Neuromuscular Exercises: Neuromuscular training could be defined as training enhancing unconscious motor responses by stimulating both afferent signals and central mechanisms responsible for dynamic joint control. Strengthening Exercises:The strengthening of the muscles promotes better overall functioning of the foot and thereby can help to take some of the tension out of the fascia. Stretching exercises:Static stretching is defined as passively stretching a given muscle-tendon unit by slowly placing it maximal position of stretch and sustaining it there for an extended period of time.

Also known as: Neuromuscular Training Anti-Pronation Low- Dye Taping Technique Intrinsic Foot Muscles Exercises Calf Muscle & Plantar Fascia Stretching VMO Strengthening
Group A (Experimental Group)Group B (Experimental Group)Group C (Control Group)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age - 18 to 35 years
  • Sex - both males \& females
  • Clinically diagnosed patient of PFPS with Pronated foot
  • Anterior or posterior pain in the knee area lasting for more than 12 weeks
  • Excessive calcaneal eversion measured at 6° in the relaxed posture
  • Score of between three and seven points on the numerical pain rating in activities of daily living Kujala Scale Point 40 \& Above

You may not qualify if:

  • A history of diagnosis of meniscus or joint injury \& knee joint surgery
  • Taking nonsteroidal anti-inflammatory drugs or corticosteroids within 24 hrs before the test
  • History of brain injury or vestibular disorder within the last 6 months
  • Positive sign of Patellar Apprehension test
  • Congenital or traumatic deformity
  • Allergic reactions to taping
  • Concomitant diagnosis of pre patellar bursitis or tendonitis
  • knee Ligamentous injury or laxity
  • Plica syndrome \& Osgood Schlatter's disease
  • Malignancy \& Skin Infection
  • Pregnant woman or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mediclinic Al Noor Hospital

Abu Dhabi, 46713, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Albert Anand.U, MPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Biomechanical Relationship of pronated foot \& Anterior knee pain
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy Team Lead - Principal Investigator

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 23, 2023

Study Start

June 15, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations