- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646306
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
Conditions
Intervention / Treatment
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
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-
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Rome, Italy, 00165
- Umberto I Hospital
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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:
|
|
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:
|
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
|
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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
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
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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