NCT07121725

Brief Summary

The purpose of the study is to identify if there is a relationship between the frontal plane projection angle as a measure of dynamic knee valgus with foot posture, pain, and dynamic balance in chronic ankle instability patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

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

December 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 3, 2025

Last Update Submit

August 10, 2025

Conditions

Keywords

Frontal plane projection angle

Outcome Measures

Primary Outcomes (3)

  • correlation between the frontal plane projection angle and foot posture in chronic ankle instability patients.

    NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle" UNIT OF MEASURE: "measured in degrees" MEASUREMENT TOOL: "using a digital camera and Kinovea software" regarding foot posture: NAME OF THE MEASUREMENT: "Foot Posture" MEASUREMENT TOOL: "assessed using the Foot Posture Index (FPI), a 6-item scale" Criteria assessed included palpating the talar head, assessing supra and infra lateral malleolar curvature, calcaneal inversion/eversion, and examining talo-navicular prominence. Additionally, the congruence of the medial longitudinal arch and the forefoot's abduction/adduction relative to the rearfoot was evaluated UNIT OF MEASURE: "scored from -12 to +12 * Highly supinated foot scores between (-5 to -12) * Supinated foot scores between (-4 to -1) * Normal foot scores between (0 to +5) * Pronated foot scores between (+6 to +9) * Highly pronated foot scores between (+10 to +12).

    baseline (single assessment session)

  • correlation between the frontal plane projection angle and pain in chronic ankle instability patients

    regarding the frontal plane projection angle: NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle" UNIT OF MEASURE: "measured in degrees" MEASUREMENT TOOL: "using a digital camera and Kinovea software" regarding pain measurement: NAME OF THE MEASUREMENT: Pain Intensity UNIT OF MEASURE: scale extending from 0 to 10 where 0 represented "no pain" and 10 represented the "worst pain possible'' MEASUREMENT TOOL: 11-point Numeric Rating Scale (NRS-11)

    baseline (single assessment session)

  • correlation between the frontal plane projection angle and dynamic balance in chronic ankle instability patients.

    regarding the frontal plane projection angle: NAME OF THE MEASUREMENT: "Frontal Plane Projection Angle" UNIT OF MEASURE: "measured in degrees" MEASUREMENT TOOL: "using a digital camera and Kinovea software" regarding dynamic balance: NAME OF THE MEASUREMENT: "Dynamic Balance" MEASUREMENT TOOL: "Modified Star Excursion Balance Test (M-SEBT)" UNIT OF MEASURE: "normalized reach distance in centimeters (cm)

    baseline (single assessment session)

Eligibility Criteria

Age15 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample will be recruited from the outpatient clinic of the Faculty of Physical Therapy at Cairo University by referral from the orthopedic doctor diagnosed with chronic ankle instability.

You may qualify if:

  • A history of at least 1 significant ankle sprain.
  • The initial sprain must have occurred at least 12 months prior to study enrollment.
  • The most recent injury must have occurred more than 3 months prior.
  • Additionally, a sprain that was associated with inflammatory symptoms (pain, swelling, etc.), Created at least 1 interrupted day of desired physical activity.
  • A history of the previously injured ankle joint as "giving way" and/or recurrent sprain and/or "feelings of instability." And the self-reported outcome measure foot and ankle ability measure (FAAM): ADL scale \<90%.

You may not qualify if:

  • History of previous surgeries or fractures to the musculoskeletal structures (i.e., bones, joint structures, nerves) in either limb.
  • No acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (i.e., sprains, fractures) resulting in at least 1 interrupted day of desired physical activity.
  • Participants were screened to exclude scoliosis using the Adam's Forward Bend Test (AFBT).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy- Cairo University

Giza, 12613, Egypt

Location

Study Officials

  • Meriam N Shafik, B.Sc

    department of musculoskeletal disorders and it's surgery- Faculty of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator of Musculoskeletal Disorders and it's Surgeries- Beni Suef University

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 13, 2025

Study Start

December 1, 2024

Primary Completion

February 28, 2025

Study Completion

April 30, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations