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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04196218
Other study ID # Pro00095486
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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