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

Shoulder Impingement Syndrome Clinical Trial

— SRPT-Iphase  

Official title:

A New Neurocognitive Interpretation of the Shoulder Position Sense During Reaching

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646306
• Other study ID #: 3826/2015
• Status: Completed
• Phase: N/A
• First received: January 3, 2016
• Last updated: March 22, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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 sagittal plane both in healthy subjects and in patients with shoulder impingement syndrome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline	Yes
Secondary	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	baseline	Yes
Secondary	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).	baseline	Yes