NCT04083391

Brief Summary

chronic ankle instability could be associated with some proximal deficits as in hip and knee regions. these deficits include alternations in motor neurons pools excitability, muscle strength, kinematics and kinetics. this study add muscle inflexibility to the preciouse literature.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

August 23, 2019

Last Update Submit

September 5, 2019

Conditions

Keywords

chronic ankle instabilityHamstringflexibility

Outcome Measures

Primary Outcomes (1)

  • Hamstring muscle flexibility

    angle between tibia and femur during passive knee extension test

    throughout the study average 1 year

Study Arms (2)

CAI group

assessment had been done to this group that include patients with ankle sprain injury from more than one year and complain with repetitive injuries, giving way and instability feelings

non injured ankle group

assessment had been done to this group that include control participants had not injured their ankle before and matched with CAI in age, gender, dominant side

Eligibility Criteria

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

Outpatients clinic faculty of physical therapy Cairo university

You may qualify if:

  • The control group was self-reported to be healthy
  • Had no ankle injury history
  • Matched with CAI patients in gender, dominance side and simulated injured side
  • CAI group had a self-report of a past history of unilateral ankle inversion injury since at least more than 1 year before the study onset which required a period of protected weight bearing and/or immobilization at least one day
  • Patient reported a tendency for the ankle to give way and/or recurrent ankle sprain
  • Perceives that the ankle was chronically weaker, more painful and/or less functional than the other ankle or than before first

You may not qualify if:

  • Had a history of lower extremity injury
  • Surgery or fracture
  • History of low back dysfunction that required medical or surgical intervention within the last year, Current participation in formal or informal rehabilitation
  • History of hamstring strain
  • Bilateral ankle sprain injury
  • Ankle injury within 3 months of participation
  • History of ankle fracture and any neuromuscluskeletal disease could affect the condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

21 patients with CAI and 21 participants without ankle sprain injury

Study Officials

  • Afaf Tahoon, Master

    assistant lecturer faculty of physical therapy Cairo university

    STUDY CHAIR

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

August 23, 2019

First Posted

September 10, 2019

Study Start

May 7, 2016

Primary Completion

December 30, 2016

Study Completion

March 9, 2017

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

IPD had been planed to be shared with research team only through specific username and password