NCT07051018

Brief Summary

The purpose of this study is to investigate the association between dynamic postural control and clinical measures of (ankle and hip strength, ankle DFROM and position sense) and radiological measures in patients with unilateral CAI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

April 6, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

April 6, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

postural controlchronic ankle instabilitytalar tilttibiotalar contact ratio

Outcome Measures

Primary Outcomes (1)

  • Y- balance test

    It is a dynamic balance test that assesses an individual's ability to maintain balance while reaching in three directions (anterior, posteromedial, and posterolateral) with one leg while standing on the other.

    baseline

Secondary Outcomes (1)

  • Radiographic measurements validated for non weight bearing radiographs (Talocrural Angle and Talar Tilt)

    baseline

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

50 participants, with age between 18- 30 years, diagnosed with unilateral CAI will be recruited through direct referrals based on their availability to participate, thus, a sample of convenience will be used.

You may qualify if:

  • At least one significant unilateral lateral ankle sprain in which the subject was unable to walk independently without the aid of crutches (the first sprain occurred more than 12 months ago).
  • Feeling of ankle instability "giving way", at least 2 episodes in the last 6 months (Terada et al., 2014).
  • Pain during intense loading.
  • The Cumberland Ankle Instability Tool (CAIT) ≤ 24.
  • Age range of 18-30 years (Delahunt et al., 2010).

You may not qualify if:

  • A previous trauma or surgery to the trunk or lower extremities other than an ankle sprain.
  • Neurological or vestibular impairments with remaining deficits.
  • No participant with CAI had acutely sprained his or her ankle in the 3 months prior to the testing.
  • Participants will be excluded if they have participated in any rehabilitation in the past 6 months.
  • Concussion or head injury or lower back pain in the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Rana Seif Youssif, Lecturer Assistant

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Assistant at faculty of physical therapy- University of Hertfordshire

Study Record Dates

First Submitted

April 6, 2025

First Posted

July 3, 2025

Study Start

July 15, 2025

Primary Completion

September 10, 2025

Study Completion

September 20, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07