NCT03731767

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

October 29, 2018

Last Update Submit

July 21, 2020

Conditions

Healthy

Keywords

ManipulationThrustAnkleLigaments

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Subject group

OTHER

Distraction thrust manipulation of the talocural joint in supine position

Procedure: Distraction thrust manipulation

Interventions

Distraction thrust manipulationPROCEDURE

Distraction thrust manipulation of the talocural joint in supine position

Subject group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Therapy Practice PC

Cape Coral, Florida, 33914, United States

Location

Study Officials

  • Rob Sillevis

    FGCU Assistent Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Pretest post test study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 6, 2018

Study Start

October 20, 2018

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)