NCT06715033

Brief Summary

This study attempted to:

  1. 1.Investigate the difference in calf muscle strength (concentric and eccentric) between affected limb with instability and non-affected limb.
  2. 2.Assess the relationship between the severity of ankle instability and calf muscle strength (concentric and eccentric) at velocity (60 and 120◦/s) in patients with functional ankle instability?
  3. 3.Investigate the relationship between calf muscle strength (concentric and eccentric) deficit and functional performance in functional ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 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

May 24, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
Last Updated

June 10, 2025

Status Verified

February 1, 2025

Enrollment Period

29 days

First QC Date

November 27, 2024

Last Update Submit

June 9, 2025

Conditions

Keywords

Calf MusclesIsokineticY balanceSide hop

Outcome Measures

Primary Outcomes (1)

  • Arabic version of the Identification of Functional Ankle Instability questionnaire (IdFAI-AR)

    asses of FAI

    1 session

Study Arms (2)

1

Group A (Experimental): 34 affected ankles of both genders diagnosed with functional ankle instability (FAI) who met the inclusion criteria. Their ages ranged from 18 to 25 years, and the patients had a history of initial injury, ongoing bouts of instability, and ratings of patient-perceived function and disability.

Diagnostic Test: y balance and SLS

2

Group B (Control): This group consisted of 34 matched non-affected ankles in the study.

Diagnostic Test: y balance and SLS

Interventions

y balance and SLSDIAGNOSTIC_TEST

for assessment of static and dynamic balance

Also known as: side hop
12

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

age sex

You may qualify if:

  • Subjects' selection was based on the following criteria:
  • Age ranged from 18 to 25 years
  • The body mass index was 18.5 to 24.9 kg/m2
  • History of at least one unilateral lateral ankle sprain that needed to be immobilized for three days or longer
  • At least one recurring sprain in the three to six months before study participation.
  • FAI if their total score is 11 or above by IdFAI.

You may not qualify if:

  • Subjects were excluded if they had any of the following criteria:
  • Previous Ankle surgery.
  • Patients with bilateral ankle instability.
  • Syndesmotic and medial ankle sprain .
  • Severe ankle arthritis.
  • Neurological disorders affect ankle function.
  • No history of ankle fractures .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafa Khafaga

Cairo, Cairo Governorate, 11511, Egypt

Location

Related Publications (1)

  • Abdelkader NA, Khafagaa MM, Aziz MZ. The gastrocnemius and soleus muscles deficits in functional ankle instability: an observational study. BMC Musculoskelet Disord. 2025 Nov 14;26(1):1046. doi: 10.1186/s12891-025-09286-4.

Study Design

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

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 4, 2024

Study Start

May 24, 2024

Primary Completion

June 22, 2024

Study Completion

October 10, 2024

Last Updated

June 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Locations