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

Completed

Study Type

Observational

Enrollment (Actual)

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

      • 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

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
Intervention / Treatment
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.
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.
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

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

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.

Investigators

  • 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

July 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 3, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

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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