Shoulder ProprioceptionNCT00889109
Shoulder Proprioception Following Open and Arthroscopic Instability Repair
An observational study of Shoulder Proprioception and Open Capsular Shift, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Shoulder dislocations are common and may result in functionally disabling instability. Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related to poor proprioceptive and stabilizing capabilities of the joint. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Proprioception, Open Capsular Shift, Arthroscopic Bankart Repair
- What is being tested?
- Three dimensional unrestricted arm movements
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Dec 2009
- Phase
- Observational
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All patients treated in our shoulder outpatients clinic will be candidates for inclusion in this study.
Who may be able to join
- Patients who are at least one year after a single operation for anterior shoulder instability of their dominant arm
- control subjects will be healthy volunteers with no history of shoulder complaints selected to match the age and gender of subjects
Who cannot join
- Neurological impairment involving the upper extremities
- Instability or recurrent dislocation of the operated shoulder
- Another surgery of the dominant extremity besides the single stabilization procedure
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel
Tel Aviv, 69978
Dario Liebermann, PhD., dlieberm@post.tau.ac.il
About this study
Official title: Proprioception of the Glenohumeral Joint Following Open and Arthroscopic Repair for Anterior Shoulder Instability
Shoulder dislocations are common and may result in functionally disabling instability. Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related to poor proprioceptive and stabilizing capabilities of the joint. It has been demonstrated that surgical restoration of the normal glenohumeral capsular tensioning improves the proprioceptive capability of the shoulder and plays an important roll in restoring shoulder stability.
Several studies compared the proprioceptive capabilities of the shoulder between different surgical procedures, however only few have used the "dynamic unrestricted 3-dimensional arm movement model" that has been shown to be more appropriate for assessment of glenohumeral proprioception. To our knowledge, no previous study has compared proprioception measures of the glenohumeral joint following arthroscopic versus open repair for anterior shoulder instability, using the 3-dimensional unrestricted arm movement model.
- Conditions
- Shoulder Proprioception, Open Capsular Shift, Arthroscopic Bankart Repair, Unrestricted Arm Movement
- Being tested
- Three dimensional unrestricted arm movements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensional unrestricted arm movementsOther
The subjects will carry out three dimensional unrestricted arm movements. The subjects' movements will be recorded by optoelectronic infrared cameras and software. Assessment of smoothness parameters of subjects' movements will allow discriminating between subjects with intact or impaired proprioception.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Open Capsular Shift Receives: Other: Three dimensional unrestricted arm movements | |
| 2 | Arthroscopic Bankart Repair Receives: Other: Three dimensional unrestricted arm movements | |
| 3 | Healthy controls Receives: Other: Three dimensional unrestricted arm movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of smoothness parameters of subjects' shoulder movements.
Measured: At least 1 year following surgical repair for anterior shoulder instability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder ProprioceptionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Dario Liebermann, PhD., Study director, Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, IsraelMoshe Peri (Pritsch), M.D, Study chair, The Shoulder Surgery Unit, Sheba Medical Center, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889109
- Sponsor's protocol ID
- SHEBA-09-7068-AO-CTIL
- Status last verified
- Apr 2009
- First submitted
- 26 Apr 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Uri O, Pritsch M, Oran A, Liebermann DG. Upper limb kinematics after arthroscopic and open shoulder stabilization. J Shoulder Elbow Surg. 2015 Mar;24(3):399-406. doi: 10.1016/j.jse.2014.08.006. Epub 2014 Oct 22.
PubMed 25441562
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioception of the Glenohumeral Joint Following Open and Arthroscopic Repair for Anterior Shoulder Instability
- ClinicalTrials.gov ID
- NCT00889109
- Acronym / sponsor ID
- SHEBA-09-7068-AO-CTIL
- Conditions
- Shoulder Proprioception, Open Capsular Shift, Arthroscopic Bankart Repair, Unrestricted Arm Movement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (estimated)
- First posted
- 28 Apr 2009 (estimated)
- 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.
Shoulder dislocations are common and may result in functionally disabling instability. Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related to poor proprioceptive and stabilizing capabilities of the joint. It has been demonstrated that surgical restoration of the normal glenohumeral capsular tensioning improves the proprioceptive capability of the shoulder and plays an important roll in restoring shoulder stability.
Several studies compared the proprioceptive capabilities of the shoulder between different surgical procedures, however only few have used the "dynamic unrestricted 3-dimensional arm movement model" that has been shown to be more appropriate for assessment of glenohumeral proprioception. To our knowledge, no previous study has compared proprioception measures of the glenohumeral joint following arthroscopic versus open repair for anterior shoulder instability, using the 3-dimensional unrestricted arm movement model.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Three dimensional unrestricted arm movementsOpen Capsular Shift |
| 2 | – | Other: Three dimensional unrestricted arm movementsArthroscopic Bankart Repair |
| 3 | – | Other: Three dimensional unrestricted arm movementsHealthy controls |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients treated in our shoulder outpatients clinic will be candidates for inclusion in this study.
Key inclusion criteria (2 listed)
- Patients who are at least one year after a single operation for anterior shoulder instability of their dominant arm
- control subjects will be healthy volunteers with no history of shoulder complaints selected to match the age and gender of subjects
Key exclusion criteria (3 listed)
- Neurological impairment involving the upper extremities
- Instability or recurrent dislocation of the operated shoulder
- Another surgery of the dominant extremity besides the single stabilization procedure
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 |
|---|---|---|
| Three dimensional unrestricted arm movementsThe subjects will carry out three dimensional unrestricted arm movements. The subjects' movements will be recorded by optoelectronic infrared cameras and software. Assessment of smoothness parameters of subjects' movements will allow discriminating between subjects with intact or impaired proprioception. | Other | 1, 2, 3 |
Primary outcome
Assessment of smoothness parameters of subjects' shoulder movements.
Time frame: At least 1 year following surgical repair for anterior shoulder instability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
- Derived from this study: PubMed 25441562Uri O, Pritsch M, Oran A, Liebermann DG. Upper limb kinematics after arthroscopic and open shoulder stabilization. J Shoulder Elbow Surg. 2015 Mar;24(3):399-406. doi: 10.1016/j.jse.2014.08.006. Epub 2014 Oct 22.
Related trials for Shoulder Proprioception
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
Not yet recruitingObservational study
Smartphone Addiction and Upper Extremity Sensorimotor Performance
Smartphone Addiction
Not yet recruiting
Virtual Reality Versus Traditional Exercise on EMG Activity in Postural Malalignment
Postural Malalignment, Forward Head Posture
Not yet recruitingObservational study
An Innovative Proprioceptive Instrument for Upper Extremities
Stroke, Shoulder Impingement Syndrome
Active, not recruiting
Precision Medicine for Nociception, Sngception and Proprioception.
Rehabilitation, Pain, Shoulder
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.
Dario Liebermann, PhD. study director
Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel
Moshe Peri (Pritsch), M.D study chair
The Shoulder Surgery Unit, Sheba Medical Center, Tel Aviv University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Proprioception and Open Capsular Shift, run by Sheba Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Apr 2009. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofir Uri, M.D (972-52-4262285, ofiruri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of smoothness parameters of subjects' shoulder movements. (time frame: At least 1 year following surgical repair for anterior shoulder instability). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889109, which also lists 1 linked publication.
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 28 Apr 2009.