HealthyNCT03731767
The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals
A study testing Distraction thrust manipulation in people with Healthy, run by Florida Gulf Coast University at 1 site in United States.
Trial summary
Measure the effect of a common used ankle manipulation on ligament length in the ankle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Distraction thrust manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrated Therapy Practice PC
Cape Coral, Florida, 33914
About this study
Measure the effect of a common used ankle manipulation on ligament length in the ankle.
Read the 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.
- Conditions
- Healthy
- Being tested
- Distraction thrust manipulation
- Keywords
- Manipulation, Thrust, Ankle, Ligaments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction thrust manipulationProcedure or surgery
Distraction thrust manipulation of the talocural joint in supine position
| Study group | Role | What they receive |
|---|---|---|
| Subject group | Other | Distraction thrust manipulation of the talocural joint in supine position Receives: Procedure: Distraction thrust manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon length
Change in ankle ligament length in millimeters measured by a method of musculoskeletal Ultrasound imaging
Measured: Measure 1 prior to manipulation. Measure 2 immediately after manipulation, within 5 minutes (the same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start20 Oct 2018
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pretest post test study design
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Sillevis, Principal investigator, FGCU Assistent Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731767
- Sponsor's protocol ID
- FloridaGCU 2018-50
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals
- ClinicalTrials.gov ID
- NCT03731767
- Acronym / sponsor ID
- FloridaGCU 2018-50
- Conditions
- Healthy
- Keywords
- Manipulation, Thrust, Ankle, Ligaments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pretest post test study design
| Arm | Type | Receives |
|---|---|---|
| Subject group | Other | Procedure: Distraction thrust manipulationDistraction thrust manipulation of the talocural joint in supine position |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distraction thrust manipulationDistraction thrust manipulation of the talocural joint in supine position | Procedure or surgery | Subject group |
Primary outcome
Tendon length
Time frame: Measure 1 prior to manipulation. Measure 2 immediately after manipulation, within 5 minutes (the same day)
Change in ankle ligament length in millimeters measured by a method of musculoskeletal Ultrasound imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Sillevis principal investigator
FGCU Assistent Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction thrust manipulation in people with Healthy, run by Florida Gulf Coast University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon length (time frame: Measure 1 prior to manipulation. Measure 2 immediately after manipulation, within 5 minutes (the same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.