Recruiting

Observational Study

Sponsor:

The Hawkins Foundation

Code:

NCT04196218

Conditions

Shoulder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Driving simulator

Study Details

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.

Conditions

Shoulder

Study ID

NCT04196218

Start date

Mar 1, 2025

Status verified date

Oct, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Driving assessment

All subjects will undergo a driving assessment(s) following shoulder surgery.

Interventions

Driving simulator

Computer simulated driving assessment

Primary outcome measure

  • Driving Assessment [ Time Frame: surgery through 12 weeks post-op ]

Central Contacts and Locations

Central contacts

Stephan Pill, MD

864 454-7394stephan.pill@prismahealth.org

Allison Nall

864 454 7458allison.nall@hawkinsfoundation.com

Locations

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Allison Nall

8644547458allison.nall@hawkinsfoundation.com

Principal Investigator:

Stephan G Pill

More Information

Sponsor

The Hawkins Foundation

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by The Hawkins Foundation on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.