The Effect of a Talocrural Thrust Manipulation on Lateral... | NCT03731767

Studies
The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals

NCT03731767

Sponsor

Florida Gulf Coast University

Status

Completed

Last Update Posted

Jul 22, 2020Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Distraction thrust manipulation

Countries

United States

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

Jul 2020

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

Oct 20, 2018Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Oct 29, 2018

First Submission Date that Met QC Criteria

Nov 2, 2018

First Posted Date

Nov 6, 2018Actual

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

Jul 21, 2020

Last Update Posted Date

Jul 22, 2020Actual

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

Measure the effect of a common used ankle manipulation on ligament length in the ankle.

Detailed Description

The purpose of this study is to determine what the effect of a common ankle manipulation on the supporting ligaments of the ankle.

Design: The researchers will conduct a quasi-experimental study with a method of convenience sampling. The design of this study will allow to determine what the direct effect of a common a commonly used physical therapy ankle manipulation is on the length of the soft tissue connection between the smaller bone in the lower leg and the heel bone and the smaller bone in the leg and the ankle bone.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subject group	Other	Distraction thrust manipulation of the talocural joint in supine position	Procedure: Distraction thrust manipulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Distraction thrust manipulation	Procedure	Distraction thrust manipulation of the talocural joint in supine position	Subject group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tendon length	Change in ankle ligament length in millimeters measured by a method of musculoskeletal Ultrasound imaging	Measure 1 prior to manipulation. Measure 2 immediately after manipulation, within 5 minutes (the same day)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18-65 years old
No current trauma to the ankle/ foot-if not present both ankles will be used during this study
No hx of fracture or surgical intervention to the ankle

Exclusion Criteria:

Red flags identified during the subjects intake. If manipulation is contraindicated the subjects will be removed from the study.
History of ankle/ foot trauma within the last 3 months.
History of surgery on the ankle/ foot.
History of knee, hip, or lower back related issues that would make the application of the ankle manipulation contraindicated.
Workers compensation and any pending legal action regarding ankle/ foot related issues.
Undergone any ankle manipulation within the last 3 weeks.
History of Osteopenia or Osteoporosis.
Inability to undergo measuring protocol.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rob Sillevis	FGCU Assistent Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrated Therapy Practice PC		Cape Coral	Florida	33914	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided