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Driving After Shoulder Surgery

NCT ID: NCT04196218

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Shoulder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Driving assessment

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

Group Type OTHER

Driving simulator

Intervention Type OTHER

Computer simulated driving assessment

Interventions

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Driving simulator

Computer simulated driving assessment

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hawkins Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Stephan Pill, MD

Role: CONTACT

Phone: 864 454-7394

Email: [email protected]

Kyle J Adams

Role: CONTACT

Phone: 864 454 7458

Email: [email protected]

Other Identifiers

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Pro00095486

Identifier Type: -

Identifier Source: org_study_id