Driving After Shoulder Surgery

NCT04196218 | Not Yet Recruiting

• 1 other identifier: Pro00095486
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Driving Assessment

  Clinical Driving Simulator

  surgery through 12 weeks post-op

Secondary Outcomes (7)

• Range of Motion

  surgery through 12 weeks post-op

• Strength

  surgery through 12 weeks post-op

• Visual Analog Pain Score

  surgery through 12 weeks post-op

• Single Alpha Numeric Evaluation of the shoulder

  surgery through 12 weeks post-op

• Veterans Rand 12 Item Health Survey

  surgery through 12 weeks post-op

Study Arms (1)

Driving assessment

OTHER

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

Other: Driving simulator

Interventions

Driving simulator OTHER

Computer simulated driving assessment

Driving assessment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Hawkins Foundation: lead

Central Study Contacts

Stephan Pill, MD

CONTACT

864 454-7394; stephan.pill@prismahealth.org

Kyle J Adams

CONTACT

864 454 7458; kyle.adams@hawkinsfoundation.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 19, 2023

Record last verified: 2023-12