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CompletedNCT04083391Updated Sep 10, 2019

Flexibility Deficit in Chronic Ankle Instability

An observational study in Chronic Ankle Instability, sponsored by Cairo University. Completed. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-10.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
42
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the detailed description

Background: influence of a localized injury in a distal joint on the function of proximal muscles is an important consideration in assessment and treatment of musculoskeletal injuries. Up to the investigator's knowledge, there is no study assess flexibility changes in CAI. Objectives: The objective of this study is to investigate Hamstring flexibility in CAI. Material and methods: The study conducted on 42 subjects with unilateral CAI and controls had measure of hamstring flexibility using digital inclinometer during passive knee extension test .Results: Revealed statistical and clinical significant difference between non-injured control group and CAI group with decreased hamstring flexibility in the later. Conclusion: CAI subjects have proximal muscular affection include hamstring tightness which may alter sacroiliac joint stability and subsequently back pain.

02

Conditions studied

  • Chronic Ankle Instability

Keywords

  • chronic ankle instability
  • Hamstring
  • flexibility
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Outpatients clinic faculty of physical therapy Cairo university

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
42 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Hamstring muscle flexibility

    angle between tibia and femur during passive knee extension test

    Time frame: throughout the study average 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 12, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD had been planed to be shared with research team only through specific username and password

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04083391
Lead sponsor
Cairo University
Responsible party
Abd Elhady Samy Abu Mandour (Principal investigator, Cairo University) — Principal investigator
First posted
Sep 10, 2019
Start date
May 7, 2016
Primary completion
Dec 30, 2016
Completion
Mar 9, 2017
Last update
Sep 10, 2019

Study contacts

Afaf Tahoon, Master
study chair · assistant lecturer faculty of physical therapy Cairo university

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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