Driving After Shoulder Surgery

Not Applicable

Not yet recruiting

• Conditions: Shoulder
• Interventions: Other: Driving simulator

• Registration Number: NCT04196218
• Lead Sponsor: The Hawkins Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-19
• Study Start: 2025-12
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Driving assessment	Driving simulator	All subjects will undergo a driving assessment(s) following shoulder surgery.

Primary Outcome Measures

Name	Time	Method
Driving Assessment	surgery through 12 weeks post-op	Clinical Driving Simulator

Secondary Outcome Measures

Name	Time	Method
Range of Motion	surgery through 12 weeks post-op	Measuring shoulder range of motion
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
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
Strength	surgery through 12 weeks post-op	Measuring shoulder strength
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
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