Trunk Muscle Strength and Endurance in Chronic Ankle Inst... | NCT05676125

Studies
Trunk Muscle Strength and Endurance in Chronic Ankle Instability

NCT05676125

Sponsor

Cairo University

Status

Completed

Last Update Posted

Aug 31, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Chronic Ankle Instability

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Jan 30, 2023Actual

Completion Date

Jan 30, 2023Actual

First Submitted Date

Dec 22, 2022

First Submission Date that Met QC Criteria

Dec 22, 2022

First Posted Date

Jan 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of trunk muscle strength in patients of chronic ankle instability

Detailed Description

This study will be conducted in the Isokinetic Laboratory. Sixty females with CAI will participate in this study. Their age will range from 18-30 years. They will be divided into two groups; the experimental and the control group. The experimental group will involve 30 females with CAI and the control group will involve 30 healthy females. The isokinetic strength of trunk muscles will be evaluated in a concentric mode of muscle contraction at an angular velocity 60°/sec. McGill test will be used to assess trunk muscle endurance.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
chronic ankle instabilty group		females with previous history of ankle sprain
control group		healthy feamles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
trunk muscles strength	concentric peak torque of trunk flexors and extensors	this will be evaluated on day one
core muscle endurance	mcgill core endurance tests	this will be evaluated on day one

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The initial sprain must have occurred at least 12 months prior to study enrollment.
The most recent injury must have occurred more than three months prior to study enrollment (unassisted walking without limping for at least three months after injury).
A history of the previously injured ankle joint giving way, recurrent sprain and/or feelings of instability.
The injured/unstable ankle functionally weaker, more painful, looser, and less functional than the uninvolved ankle.
The Oswesty Disability Index (ODI) score for both groups is from 0 to 20% (minimal disability) (Fairbank and Pynsent, 2000).

6- The Identification of Functional Ankle Instability questionnaire (IdFAI) score is less than 10 for the experimental group and 11 or more for the control group (Simon et al., 2012).

Exclusion Criteria:

1-A history of previous surgeries or fractures in either limb of lower extremity.

2-Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous three months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least one interrupted day of desired physical activity.

3-Any positive ﬁndings of the anterior drawer or talar tilt test (Hubbard and Kaminski, 2002).

4-Any shoulder (Kibler et al., 2006) or elbow injuries (Ben Kibler and Sciascia, 2004).

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

females are at higher risk than male

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

faculty of physical therapy outpatient clinic

Sampling Method

Non-Probability Sample