NCT05676125

Brief Summary

Evaluation of trunk muscle strength in patients of chronic ankle instability

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

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, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

December 22, 2022

Last Update Submit

August 29, 2023

Conditions

Keywords

CAI

Outcome Measures

Primary Outcomes (2)

  • trunk muscles strength

    concentric peak torque of trunk flexors and extensors

    this will be evaluated on day one

  • core muscle endurance

    mcgill core endurance tests

    this will be evaluated on day one

Study Arms (2)

chronic ankle instabilty group

females with previous history of ankle sprain

control group

healthy feamles

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales are at higher risk than male
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

faculty of physical therapy outpatient clinic

You may qualify if:

  • The initial sprain must have occurred at least 12 months prior to study enrollment.
  • The most recent injury must have occurred more than three months prior to study enrollment (unassisted walking without limping for at least three months after injury).
  • A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability.
  • The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle.
  • The Oswesty Disability Index (ODI) score for both groups is from 0 to 20% (minimal disability) (Fairbank and Pynsent, 2000).
  • The Identification of Functional Ankle Instability questionnaire (IdFAI) score is less than 10 for the experimental group and 11 or more for the control group (Simon et al., 2012).

You may not qualify if:

  • A history of previous surgeries or fractures in either limb of lower extremity.
  • Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.
  • Any positive findings of the anterior drawer or talar tilt test (Hubbard and Kaminski, 2002).
  • Any shoulder (Kibler et al., 2006) or elbow injuries (Ben Kibler and Sciascia, 2004).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Dokki, 12613, Egypt

Location

Study Officials

  • salam M Elhafez, Professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 9, 2023

Study Start

December 1, 2022

Primary Completion

January 30, 2023

Study Completion

January 30, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations