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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03731767
Other study ID # FloridaGCU 2018-50
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2018
Est. completion date August 1, 2019

Study information

Verified date July 2020
Source Florida Gulf Coast University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Distraction thrust manipulation
Distraction thrust manipulation of the talocural joint in supine position

Locations

Country Name City State
United States Integrated Therapy Practice PC Cape Coral Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida Gulf Coast University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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