Driving After Shoulder Surgery

NCT04196218 — Not applicable, Recruiting, 150 participants, The Hawkins Foundation

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Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty

Registry	NCT04196218
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, health services research
Enrollment	150 (Estimated)
Sponsor	The Hawkins Foundation (Other)
Conditions	Shoulder
Interventions	Driving simulator (Other)
Dates	start 2025-03-01, primary completion 2026-12-01 (estimated), completion 2027-06-01 (estimated), first posted 2019-12-12, last updated 2026-10-19
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Driving assessment	Other	Other: Driving simulator	All subjects will undergo a driving assessment(s) following shoulder surgery.

Driving simulator (Other): Computer simulated driving assessment

+Outcome measures

Primary outcomes

Driving Assessment [surgery through 12 weeks post-op]: Clinical Driving Simulator

Secondary outcomes

Range of Motion [surgery through 12 weeks post-op]: Measuring shoulder range of motion
Strength [surgery through 12 weeks post-op]: Measuring shoulder strength
Visual Analog Pain Score [surgery through 12 weeks post-op]: Patient reported level of pain on a scale of 0 to 10, with 10 being extreme pain and 0 being no pain
Single Alpha Numeric Evaluation of the shoulder [surgery through 12 weeks post-op]: Percentage of normal for affected shoulder between 0 and 100, with 100 being a perfectly "normal" shoulder and 0 being a completely "abnormal" shoulder
Veterans Rand 12 Item Health Survey [surgery through 12 weeks post-op]: 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
Brief Resilience Scale [surgery through 12 weeks post-op]: Patient reported resilience on a scale of 0 to 30, with 30 indicating high resilience and 0 indicating low resilience
Shoulder function [surgery through 12 weeks post-op]: Shoulder function as measured by American Shoulder and Elbow Surgeons assessment

+Eligibility

Sex: All

Inclusion Criteria:

1. Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon
2. Patients receiving physical therapy from ATI Patewood clinic
3. Must be able and willing to complete all study assessments and to be followed for the full course of the study.
4. Must be able to read, write and follow instructions in English.
5. In the opinion of the investigator, is that they subject is competent to participate in study activities
6. Prior to injury, patient was routinely driving.

Exclusion Criteria:

1. Prior shoulder surgery in the last 90 day
2. Individuals with a history of any underlying neurological conditions

+Locations (1)

Facility	City	Country	Status
Prisma Health	Greenville, South Carolina	United States	Recruiting