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Telerehabilitation for Shoulder Arthritis
N/A
Waitlist Available
Led By Brendan M Patterson, MD, MPH
Research Sponsored by Olivia C. O'Reilly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of formal in-person physical therapy versus telerehabilitation (video-based physical therapy) after shoulder arthroplasty. The aim is to identify any differences in shoulder range of motion, pain, or patient-reported outcome measures between the two groups.
Who is the study for?
This trial is for patients scheduled for primary shoulder arthroplasty, either anatomic or reverse, by specific orthopedic surgeons. It's not open to those getting the surgery due to a fracture, unwilling participants, those having additional procedures like tendon transfers, or patients needing revision surgeries.Check my eligibility
What is being tested?
The study tests telerehabilitation—physical therapy through online video conferencing—against traditional in-person physical therapy after shoulder arthroplasty. The goal is to compare outcomes such as range of motion, pain levels and patient-reported outcomes between the two methods.See study design
What are the potential side effects?
Since this trial involves non-invasive telecommunication technology for rehabilitation rather than medication or surgical intervention, typical drug-related side effects are not applicable. However, there may be differences in recovery experiences between the two groups.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Elbow
PROMIS Global Health score
PROMIS Pain Interference
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TelerehabilitationExperimental Treatment1 Intervention
Subjects who are randomized to telerehabilitation will be provided access to telemedicine visits with a physical therapist. Patients will have one in-person physical therapy visit before starting telerehabilitation, and another in-person visit at 3 months to assess progress. Telerehabilitation visits will be performed via secure usage of the electronic medical record (EMR). To ensure uniformity, and to allow for appropriate access to telehealth services, all telehealth visits will be carried out through the study institution's Department of Physical Therapy. It is expected most patients will complete formal physical therapy by 6 months postoperative measured by the time at which patient's regain functional range of motion or patients are satisfied with their results. Shoulder range of motion will be measured with a goniometer preoperatively, as well as 3,6, 12, and 24 months postoperatively at their regularly scheduled clinic visit.
Group II: Traditional In-Person Physical TherapyActive Control1 Intervention
Subjects who are randomized to in-person therapy will present to a physical therapist of their choice with a established written protocol. The therapy protocol is developed in conjunction with the Department of Orthopaedic Surgery and the Department of Physical Therapy. Subjects are recommended to attend in-person appointments at least once a week as well as perform home exercises. Progress with therapy will be collected with weekly phone calls from the research team. It is expected most subjects will complete formal physical therapy by 6 months postoperative attending on average 5-6 visits, measured by the time at which patient's regain functional range of motion or are instructed by their therapist to discontinue. Shoulder range of motion will be measured with a goniometer preoperatively, as well as 3,6, 12, and 24 months postoperatively at their regularly scheduled clinic visit.
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Who is running the clinical trial?
Olivia C. O'ReillyLead Sponsor
Brendan M Patterson, MD, MPHPrincipal InvestigatorUniversity of Iowa
Olivia O'Reilly, MDPrincipal InvestigatorUniversity of Iowa
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a corrective surgical procedure.I am having additional procedures, like tendon transfer, alongside my main treatment.I am recommended for shoulder replacement surgery by a specialist.I am having joint replacement surgery due to a fracture.I do not want to participate in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Telerehabilitation
- Group 2: Traditional In-Person Physical Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment for this research endeavor begun?
"According to clinicaltrials.gov, the trial has not been actively recruiting participants since August 11th 2022. Despite its inactivity, there are still 230 other medical studies looking for volunteers right now."
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Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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