Driving After Shoulder Surgery

Shoulder Clinical Trial

Official title:

Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04196218
• Other study ID #: Pro00095486
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2025
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: The Hawkins Foundation
• Contact: Stephan Pill, MD
• Phone: 864 454-7394
• Email: stephan.pill[@]prismahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder

Intervention

Other:
• Driving simulator
Computer simulated driving assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hawkins Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Assessment	Clinical Driving Simulator	surgery through 12 weeks post-op
Secondary	Range of Motion	Measuring shoulder range of motion	surgery through 12 weeks post-op
Secondary	Strength	Measuring shoulder strength	surgery through 12 weeks post-op
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Shoulder function	Shoulder function as measured by American Shoulder and Elbow Surgeons assessment	surgery through 12 weeks post-op