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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: Distraction thrust manipulation

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Cape Coral, Florida, United States, 33914
      • Integrated therapy Practice PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Subject group; Distraction thrust manipulation of the talocural joint in supine position	Procedure: Distraction thrust manipulation; Distraction thrust manipulation of the talocural joint in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Investigators: Principal Investigator: Rob Sillevis, FGCU Assistent Professor

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2018
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (ACTUAL): November 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Ankle; Manipulation; Thrust; Ligaments
• Other Study ID Numbers: FloridaGCU 2018-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No