Asymptomatic ConditionNCT04775628
Forces and Translation Distance During an Inferior Glide of the Shoulder
A study testing Inferior glide humerus in GH joint in people with Asymptomatic Condition, run by Dr. Rob Sillevis, at 1 site in United States.
Trial summary
This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Condition
- What is being tested?
- Inferior glide humerus in GH joint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 May 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
- Healthy volunteers
- Able to read the English language fluently
Who cannot join
- a history of injury of the right shoulder
- right shoulder surgery
- presence of shoulder pain
- comorbidities affecting natural ROM within the dominant shoulder
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Gulf Coast University
Fort Myers, Florida, 33965
About this study
Official title: Forces and Translation Distance During an Inferior Glide of the Shoulder in Healthy Subjects Measured With the Novel Pliance Glove and Ultrasound Imaging
This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus.
Read the detailed description
There has been limited research on how the variance of force affects MT outcomes and what the best practices of MT should be. No specific force threshold necessary to achieve a predetermined translational distance within the joint has been quantified within the literature. The purpose of this study was to quantify the amount of force necessary to perform an inferior glide to the glenohumeral joint and reach to end-range. A secondary aim was to determine the impact of co-variables, such as gender, height, weight, and age, on the amount of force required to translate the humeral head within the glenohumeral joint. Musculoskeletal Ultrasound imaging using the GE LogiQe was used to measure the translation of the humeral head. The manipulation force was measured using the Novel Pliance Glove device and software.
- Conditions
- Asymptomatic Condition
- Being tested
- Inferior glide humerus in GH joint
- Keywords
- Manipulation force, Glenohumeral joint, Musculoskeletal Ultrasound Imaging
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior glide humerus in GH jointProcedure or surgery
Supine inferior glide GH joint
| Study group | Role | What they receive |
|---|---|---|
| inferior glide | Experimental | Inferior glide of the right humerus till no motion is visual on the imaging Receives: Procedure: Inferior glide humerus in GH joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Translation
Measured in mm using MSK Ultrasound
Measured: 5 minutes
Force measure
Force measure during inferior glide using Novel Pliance Glove
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jun 2018
- Primary completion1 Nov 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic ConditionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subject design
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Rob Sillevis,
- Sponsor type
- University, hospital or other
- Collaborators
- Mitchell Todd, J.P Speare, Eric Shamus, Arie van Duijn
- Responsible party
- Sponsor-investigator, Dr. Rob Sillevis,, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775628
- Sponsor's protocol ID
- 2018-015
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 7 Apr 2022
- Results posted
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forces and Translation Distance During an Inferior Glide of the Shoulder in Healthy Subjects Measured With the Novel Pliance Glove and Ultrasound Imaging
- ClinicalTrials.gov ID
- NCT04775628
- Acronym / sponsor ID
- 2018-015
- Conditions
- Asymptomatic Condition
- Keywords
- Manipulation force, Glenohumeral joint, Musculoskeletal Ultrasound Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dr. Rob Sillevis,University, hospital or other
- Collaborators
- Mitchell Todd, J.P Speare, Eric Shamus, Arie van Duijn
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 1 Mar 2021 (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.
This study evaluates the force and translation distance in the GH joint during a manual inferior glide of the humerus.
Detailed description
There has been limited research on how the variance of force affects MT outcomes and what the best practices of MT should be. No specific force threshold necessary to achieve a predetermined translational distance within the joint has been quantified within the literature. The purpose of this study was to quantify the amount of force necessary to perform an inferior glide to the glenohumeral joint and reach to end-range. A secondary aim was to determine the impact of co-variables, such as gender, height, weight, and age, on the amount of force required to translate the humeral head within the glenohumeral joint. Musculoskeletal Ultrasound imaging using the GE LogiQe was used to measure the translation of the humeral head. The manipulation force was measured using the Novel Pliance Glove device and software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subject design
| Arm | Type | Receives |
|---|---|---|
| inferior glide | Experimental | Procedure: Inferior glide humerus in GH jointInferior glide of the right humerus till no motion is visual on the imaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Able to read the English language fluently
Key exclusion criteria (4 listed)
- a history of injury of the right shoulder
- right shoulder surgery
- presence of shoulder pain
- comorbidities affecting natural ROM within the dominant shoulder
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 |
|---|---|---|
| Inferior glide humerus in GH jointSupine inferior glide GH joint | Procedure or surgery | inferior glide |
Primary outcome
Translation
Time frame: 5 minutes
Measured in mm using MSK Ultrasound
Force measure
Time frame: 5 minutes
Force measure during inferior glide using Novel Pliance Glove
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 7 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior glide humerus in GH joint in people with Asymptomatic Condition, run by Dr. Rob Sillevis, 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 2 inclusion and 4 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 7 Apr 2022. 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?
Translation (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 7 Apr 2022.