NCT02646306

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
Last Updated

March 23, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

January 3, 2016

Last Update Submit

March 22, 2016

Conditions

Keywords

shoulderproprioceptionmovementreaching

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Evaluation of the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (Quick-DASH) at baseline

    baseline

  • Evaluation of the Constant-Murley shoulder outcome score at baseline

    baseline

Study Arms (2)

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

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

Interventions

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.

Also known as: SRPT
Healthy SubjectsShoulder Impingement Syndrome

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects affected by shoulder impingement syndrome and healthy subjects.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umberto I Hospital

Rome, 00165, Italy

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Vincenzo Maria Saraceni

    Umberto I Hospital, University "Sapienza" of Rome

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 5, 2016

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

March 23, 2016

Record last verified: 2016-01

Locations