Driving After Shoulder Surgery

The Hawkins Foundation (Other)
Overall Status
Not yet recruiting
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Driving simulator

Study Design

Study Type:
Anticipated Enrollment :
150 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Driving assessment

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

Other: Driving simulator
Computer simulated driving assessment

Outcome Measures

Primary Outcome Measures

  1. Driving Assessment [surgery through 12 weeks post-op]

    Clinical Driving Simulator

Secondary Outcome Measures

  1. Range of Motion [surgery through 12 weeks post-op]

    Measuring shoulder range of motion

  2. Strength [surgery through 12 weeks post-op]

    Measuring shoulder strength

  3. 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

  4. 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

  5. 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

  6. 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

  7. Shoulder function [surgery through 12 weeks post-op]

    Shoulder function as measured by American Shoulder and Elbow Surgeons assessment

Eligibility Criteria


Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • The Hawkins Foundation


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
The Hawkins Foundation
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • Pro00095486
First Posted:
Dec 12, 2019
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 19, 2022