Driving After Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
Patients undergoing a shoulder arthroplasty or rotator cuff repair will be enrolled in the study. Patients will be asked to undergo driving simulator assessments post-operatively in ATI Physical Therapy for up to 12 weeks after surgery in order to determine when it may be safe for them to return to driving. Additional assessments include patient-reported outcomes, range of motion, and strength measures, which are all standard of care. Study participation concludes when the patient passes the driving simulator test.

Official Title
-----------------
Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty

Conditions
-----------------
Shoulder

Intervention / Treatment
-----------------
* Other: Driving simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon Patients receiving physical therapy from ATI Patewood clinic Must be able and willing to complete all study assessments and to be followed for the full course of the study. Must be able to read, write and follow instructions in English. In the opinion of the investigator, is that they subject is competent to participate in study activities Prior to injury, patient was routinely driving. Exclusion Criteria: Prior shoulder surgery in the last 90 day Individuals with a history of any underlying neurological conditions
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Driving assessment<br>All subjects will undergo a driving assessment(s) following shoulder surgery. | Other: Driving simulator<br>* Computer simulated driving assessment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving Assessment | Clinical Driving Simulator | surgery through 12 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Measuring shoulder range of motion | surgery through 12 weeks post-op | 
| Strength | Measuring shoulder strength | surgery through 12 weeks post-op | 
| Visual Analog Pain Score | Patient reported level of pain on a scale of 0 to 10, with 10 being extreme pain and 0 being no pain | surgery through 12 weeks post-op | 
| Single Alpha Numeric Evaluation of the shoulder | Percentage of normal for affected shoulder between 0 and 100, with 100 being a perfectly normal shoulder and 0 being a completely abnormal shoulder | surgery through 12 weeks post-op | 
| Veterans Rand 12 Item Health Survey | Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores | surgery through 12 weeks post-op | 
| Brief Resilience Scale | Patient reported resilience on a scale of 0 to 30, with 30 indicating high resilience and 0 indicating low resilience | surgery through 12 weeks post-op | 
| Shoulder function | Shoulder function as measured by American Shoulder and Elbow Surgeons assessment | surgery through 12 weeks post-op |