ShoulderNCT04196218
Driving After Shoulder Surgery
A study testing Driving simulator in people with Shoulder, run by The Hawkins Foundation at 1 site in United States.
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 pre-operatively through 9 weeks after surgery in order to determine when it may be safe for them to return to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder
- What is being tested?
- Driving simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon
- 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.
Who cannot join
- Prior shoulder surgery in the last 90 day
- Individuals with a history of any underlying neurological conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health
Greenville, South Carolina, 29615
Allison Nall, 8644547458, allison.nall@hawkinsfoundation.com
Stephan G Pill
About this study
Official title: Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty
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 pre-operatively through 9 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
- Being tested
- Driving simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving simulatorOther
Computer simulated driving assessment
| Study group | Role | What they receive |
|---|---|---|
| Driving assessment | Other | All subjects will undergo a driving assessment(s) following shoulder surgery. Receives: Other: Driving simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons Survey (ASES)
Shoulder function as measured by American Shoulder and Elbow Surgeons assessment
Measured: pre op through 9 weeks post-op
Secondary outcomes (7)
Range of Motion
Measuring shoulder range of motion
Measured: Pre-op through 9 weeks post-op
Strength
Measuring shoulder strength
Measured: Pre-op through 9 weeks post-op
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
Measured: Pre-op through 9 weeks post-op
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
Measured: Pre-op through 9 weeks post-op
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
Measured: Pre-op through 9 weeks post-op
Brief Resilience Scale
Patient reported resilience on a scale of 0 to 30, with 30 indicating high resilience and 0 indicating low resilience
Measured: Pre-op through 9 weeks post-op
Driving Assessment
Clinical Driving Simulator
Measured: Pre-op through 9 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196218
- Sponsor's protocol ID
- Pro00095486
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2019
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving After Arthroscopic Rotator Cuff Repair or Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04196218
- Acronym / sponsor ID
- Pro00095486
- Conditions
- Shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 pre-operatively through 9 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Driving assessment | Other | Other: Driving simulatorAll subjects will undergo a driving assessment(s) following shoulder surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing either Rotator Cuff Repair or Shoulder arthroplasty from participating surgeon
- 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.
Key exclusion criteria (2 listed)
- Prior shoulder surgery in the last 90 day
- Individuals with a history of any underlying neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Driving simulatorComputer simulated driving assessment | Other | Driving assessment |
Primary outcome
American Shoulder and Elbow Surgeons Survey (ASES)
Time frame: pre op through 9 weeks post-op
Shoulder function as measured by American Shoulder and Elbow Surgeons assessment
7 secondary outcomes
Range of Motion
Time frame: Pre-op through 9 weeks post-op
Strength
Time frame: Pre-op through 9 weeks post-op
Visual Analog Pain Score
Time frame: Pre-op through 9 weeks post-op
Single Alpha Numeric Evaluation of the shoulder
Time frame: Pre-op through 9 weeks post-op
Veterans Rand 12 Item Health Survey
Time frame: Pre-op through 9 weeks post-op
Brief Resilience Scale
Time frame: Pre-op through 9 weeks post-op
Driving Assessment
Time frame: Pre-op through 9 weeks post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving simulator in people with Shoulder, run by The Hawkins Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Pill, MD (864 454-7394, stephan.pill@prismahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons Survey (ASES) (time frame: pre op through 9 weeks post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.