NCT06188416

Brief Summary

This study investigates the difference in dynamic Q-angle of patients with chronic ankle instability and those without.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

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

October 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 18, 2023

Last Update Submit

December 18, 2023

Conditions

Keywords

Kinetic chainAnkle instabilityQ-angle

Outcome Measures

Primary Outcomes (1)

  • Dynamic Q-angle

    Using dynamic knee valgus through the measurement of frontal plane projection angle

    6 months

Study Arms (2)

Cases with CAI

Cases that reported previous experience of chronic ankle instability

Cases without CAI

Cases that did not report any previous experience of chronic ankle instability

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The participants from both genders aged between 18 and 30 years will be divided into 2 groups: a study group and a control group. The study group consists of 52 participants with chronic ankle instability, and the control group consists of 52 participants without chronic ankle instability, normal participants with no musculoskeletal disorders or history of knee disease and no obvious limb length discrepancy.

You may qualify if:

  • Subjects aged between 18 and 30 years.
  • Subjects with a history of LAS for at least one year before the study onset, that required at least 1-day weight-bearing restriction.
  • Subjects with a self-reported tendency of ≥2 giving way episodes during 6 months before enrollment in the study.
  • Subjects with a perception that the injured ankle was chronically weaker, more painful, and/or less functional than the contralateral ankle before the first LAS.
  • Subjects who scored less than 24 in the Cumberland Ankle Instability Tool (CAIT), a validated ankle instability specific questionnaire of 9 items, to determine if functional ankle instability is present.

You may not qualify if:

  • Subjects who had bilateral LAS
  • Subjects with a history of lower extremity injury, fracture, or surgery
  • Subjects who participated in supervised or unsupervised ankle rehabilitation within a year before enrollment in the study
  • Subjects with LAS within 3 months before participation
  • Subjects with a history of knee pain during the last 6 months.
  • Subjects diagnosed with knee osteoarthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Dokki, Giza Governorate, 12613, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

October 7, 2023

Primary Completion

November 26, 2023

Study Completion

December 3, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations