A New Shoulder Proprioceptive Rehabilitative Tool (SRPT) for the Evaluation of the Role of the Shoulder During Reaching (SRPT-Iphase)

March 22, 2016 updated by: Teresa Paolucci, University of Roma La Sapienza

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00165
        • Umberto I Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects affected by shoulder impingement syndrome and healthy subjects.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: shoulder proprioceptive rehabilitation tool
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.
Other Names:
  • SRPT
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.
Other: shoulder proprioceptive rehabilitation tool
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.
Other Names:
  • SRPT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH) at baseline
Time Frame: 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
baseline
Evaluation of the Constant-Murley shoulder outcome score at baseline
Time Frame: 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).
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vincenzo Maria Saraceni, Umberto I Hospital, University "Sapienza" of Rome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3826/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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