Shoulder Impingement SyndromeSRPT-IphaseNCT02646306
A New Shoulder Proprioceptive Rehabilitative Tool (SRPT) for the Evaluation of the Role of the Shoulder During Reaching
An observational study of Shoulder Impingement Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of the study focused on the creation of a rehabilitative measuring device (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination methodology for assessing the proprioception of the glenohumeral joint respect to scapula abduction, within the movement of antepulsion on the… Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- shoulder proprioceptive rehabilitation tool
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2015to Jan 2016
- 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 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects affected by shoulder impingement syndrome and healthy subjects.
Who may be able to join
- Right-handed
- Diagnosis of subacromial right impingement syndrome performed by the orthopedic specialist (nuclear magnetic resonance and/or ultrasound examination)
- Neer stages 1, 2 and 3
- Presence of pain 3 <VAS<8 at baseline
- Age between 55 and 65 years.
Who cannot join
- Diabetes mellitus
- Inflammatory systemic diseases
- CNS and/or PNS diseases
- Systemic infectious diseases
- Neoplastic diseases
- Assumption of antidepressants and/or anxiolytics and/or other medications that can affect attention and sensory
- Visual problems not properly compensated
- Previous surgery to the shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Neurocognitive Interpretation of the Shoulder Position Sense During Reaching
The aim of the study focused on the creation of a rehabilitative measuring device (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination methodology for assessing the proprioception of the glenohumeral joint respect to scapula abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects and in patients with shoulder impingement syndrome.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- shoulder proprioceptive rehabilitation tool
- Keywords
- shoulder, proprioception, movement, reaching
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shoulder proprioceptive rehabilitation toolOther
Also called SRPT
Using of this tool to measure which is the average error in reaching back in both healthy subjects and subjects with shoulder impingement syndrome starting from the assumption that the shoulder, through the articulation scapulothoracic, helps to determine direction and distance during the "reaching" of an object.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Impingement Syndrome | Execution of two tests in succession with the use of the shoulder proprioceptive rehabilitation tool (SRPT), each oriented to indicate a specific discriminative and integrative mode in the movement of the scapulothoracic. Will be required to each subject to perform recognition tasks that include both retraction movements of the hand, starting from a start position, and approaching movements of the hand, starting from an end position. First test: ability to integrate visual and proprioceptive informations. Second test: discriminative proprioceptive capacity of the subject, thus excluding the contribution of the view. Receives: Other: shoulder proprioceptive rehabilitation tool | |
| Healthy Subjects | Execution of two tests in succession with the use of the shoulder proprioceptive rehabilitation tool (SRPT), each oriented to indicate a specific discriminative and integrative mode in the movement of the scapulothoracic. Will be required to each subject to perform recognition tasks that include both retraction movements of the hand, starting from a start position, and approaching movements of the hand, starting from an end position. First test: ability to integrate visual and proprioceptive informations. Second test: discriminative proprioceptive capacity of the subject, thus excluding the contribution of the view. Receives: Other: shoulder proprioceptive rehabilitation tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Visual Analogue Scale (VAS) at baseline
It is an instrument that enables patients to express their pain intensity as a numerical value. Patients were asked to mark the point that corresponded to their perceived pain intensity on a 10-cm line, with 0 indicating the absence of pain and 10 reflecting the most severe pain
Measured: baseline
Secondary outcomes (2)
Evaluation of the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH) at baseline
The short form (11 item) of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH) measures physical ability and symptoms of the upper extremity and explores the impact of functional impairment and pain on daily-living tasks, as well as on social and recreational activities, work and sleep. The score ranges from 0 to 100 points, with 0 reflect- ing no disability and 100 corresponding to the most severe disability
Measured: baseline
Evaluation of the Constant-Murley shoulder outcome score at baseline
It is based on subjective (sleep, work, and recreational activities) and objective (ROM and strength) components, adjusted for age and sex, according to normative values reported by Yian et al. The score ranges from 0 (worst result) to 100 (best result).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Paolucci, University of Roma La Sapienza
- Investigators
- Vincenzo Maria Saraceni, Principal investigator, Umberto I Hospital, University "Sapienza" of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646306
- Sponsor's protocol ID
- 3826/2015
- Acronym
- SRPT-Iphase
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 2016
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Neurocognitive Interpretation of the Shoulder Position Sense During Reaching
- ClinicalTrials.gov ID
- NCT02646306
- Acronym / sponsor ID
- SRPT-Iphase / 3826/2015
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder, proprioception, movement, reaching
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Jan 2016 (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.
The aim of the study focused on the creation of a rehabilitative measuring device (SRPT-shoulder proprioceptive rehabilitation tool) and the development of the examination methodology for assessing the proprioception of the glenohumeral joint respect to scapula abduction, within the movement of antepulsion on the sagittal plane both in healthy subjects and in patients with shoulder impingement syndrome.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder Impingement Syndrome | – | Other: shoulder proprioceptive rehabilitation toolExecution of two tests in succession with the use of the shoulder proprioceptive rehabilitation tool (SRPT), each oriented to indicate a specific discriminative and integrative mode in the movement of the scapulothoracic. Will be required to each subject to perform recognition tasks that include both retraction movements of the hand, starting from a start position, and approaching movements of the hand, starting from an end position. First test: ability to integrate visual and proprioceptive informations. Second test: discriminative proprioceptive capacity of the subject, thus excluding the contribution of the view. |
| Healthy Subjects | – | Other: shoulder proprioceptive rehabilitation toolExecution of two tests in succession with the use of the shoulder proprioceptive rehabilitation tool (SRPT), each oriented to indicate a specific discriminative and integrative mode in the movement of the scapulothoracic. Will be required to each subject to perform recognition tasks that include both retraction movements of the hand, starting from a start position, and approaching movements of the hand, starting from an end position. First test: ability to integrate visual and proprioceptive informations. Second test: discriminative proprioceptive capacity of the subject, thus excluding the contribution of the view. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects affected by shoulder impingement syndrome and healthy subjects.
Key inclusion criteria (5 listed)
- Right-handed
- Diagnosis of subacromial right impingement syndrome performed by the orthopedic specialist (nuclear magnetic resonance and/or ultrasound examination)
- Neer stages 1, 2 and 3
- Presence of pain 3 <VAS<8 at baseline
- Age between 55 and 65 years.
Key exclusion criteria (8 listed)
- Diabetes mellitus
- Inflammatory systemic diseases
- CNS and/or PNS diseases
- Systemic infectious diseases
- Neoplastic diseases
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 |
|---|---|---|
| shoulder proprioceptive rehabilitation toolAlso: SRPTUsing of this tool to measure which is the average error in reaching back in both healthy subjects and subjects with shoulder impingement syndrome starting from the assumption that the shoulder, through the articulation scapulothoracic, helps to determine direction and distance during the "reaching" of an object. | Other | Healthy Subjects, Shoulder Impingement Syndrome |
Primary outcome
Evaluation of the Visual Analogue Scale (VAS) at baseline
Time frame: baseline
It is an instrument that enables patients to express their pain intensity as a numerical value. Patients were asked to mark the point that corresponded to their perceived pain intensity on a 10-cm line, with 0 indicating the absence of pain and 10 reflecting the most severe pain
2 secondary outcomes
Evaluation of the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH) at baseline
Time frame: baseline
Evaluation of the Constant-Murley shoulder outcome score at baseline
Time frame: baseline
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 23 Mar 2016.
Related trials for Shoulder Impingement Syndrome
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"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
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Natural History of Shoulder Pathology in Manual Wheelchair Users
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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.
Vincenzo Maria Saraceni principal investigator
Umberto I Hospital, University "Sapienza" of Rome
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 Impingement Syndrome, run by University of Roma La Sapienza at 1 site in Italy.
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 5 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 23 Mar 2016. 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 Italy. 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?
Evaluation of the Visual Analogue Scale (VAS) at baseline (time frame: baseline). 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 23 Mar 2016.