NCT04555083

Brief Summary

chronic ankle instability previously approved in many studies that it may lead to more proximal adaptations and negative long term consequences. one of those studies reported, ankle instability patients has hamstring muscle shortening in comparison with non sprained subjects. another one concluded that gluteus maximums muscle has delayed activation and weakness in CAI patients. Both muscles (hamstring and gluteus Maximus ) contribute to sacroiliac joint stability. therefore, this study asked a novel research question, was sacroiliac joint dysfunction (SIJD) associated with CAI?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

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

January 3, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

September 14, 2020

Last Update Submit

June 7, 2021

Conditions

Keywords

chronic ankle instabilitySacroiliac joint dysfunction

Outcome Measures

Primary Outcomes (1)

  • odd's ratio of sacroiliac joint dysfunction

    association between CAI and sacroiliac joint dysfunction

    throughout the study about 1 year

Secondary Outcomes (3)

  • difference of pelvic torsion between CAI and control

    throughout the study about 1 year

  • correlation between pelvic torsion and giving way episodes

    throughout the study about one year

  • corelation between pelvic torsion and perceived sensation of instability

    throughout the study about 1 year

Study Arms (2)

CAI group

Case group is CAI group that recruit patients complain of ankle insatiability and giving way mainly

control group

control group recruits participants with non injured ankle, matched with case group in gender and dominant limb

Eligibility Criteria

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

Recruited from faculty of physical therapy through announcements for volunteering to participate in noninvasive study include patients complaining of ankle instability and others did not have any injury in their ankle before

You may qualify if:

  • young active people between 18-30 years old
  • CAI group has a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset
  • Required a period of protected weight bearing and/or immobilization at least one day
  • The patient reported a tendency to give way or repeatedly turn over during functional activity
  • At least 2 giving way episodes during the year before the study onset and/or recurrent ankle sprain
  • Perceived that the ankle was chronically weaker, more painful, and/or less functional than other non-injured ankle or than before first injury.
  • Positive anterior drawer test and /or talar tilt test

You may not qualify if:

  • Trunk asymmetry angle 5 - 7 degrees
  • Leg length difference more than 0.5 cm
  • History of autoimmune diseases, complains of ankylosing spondylitis and morning stiffness
  • Participation in physical therapy regimen within a year before enrolling in the study
  • Bilateral ankle sprain injury
  • Ankle sprain within 3 months of participation
  • If they had only midline or symmetrical pain above the level of L5 or radicular pain with neurological deficits (sensory or motor deficits)
  • History of spinal surgery, infection, tumors, fracture of the spine, pelvis or lower extremities within 2 years before enrolling in the study.
  • Hospitalization for severe trauma or car accident
  • Pregnant women
  • Any neurological and orthopedics diseases could affect the conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

‪Afaf Tahoon‬

Dokki, Giza Governorate, 12555, Egypt

Location

Study Officials

  • Dalia mossad, professor

    professor at faculty of physical therapy Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 18, 2020

Study Start

January 3, 2020

Primary Completion

September 30, 2020

Study Completion

November 30, 2020

Last Updated

June 8, 2021

Record last verified: 2021-06

Locations