Virtual Physical Therapy Support for Runners

May 13, 2026 updated by: University of Florida

Virtual Physical Therapy Support for Runners Receiving Gait Analyses for Lower Body Running Related Musculoskeletal Issues

This study will compare standard of care of home exercise for running rehabilitation to the combined treatment of home exercise with an individually provided four-session virtual physical therapy support program intervention on pain and physical function movements (controlled dual and single leg squat and lateral hopping in individuals post running injury. These collective findings will help provide new evidence of the responses to an individually provided virtual PT interventions among runners.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
85

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • University of Florida College of medicine- Dept of PM&R
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age of 18 to 65 years
  • Regularly running at least 12 miles a week prior to development of musculoskeletal complaint.
  • Free of surgical history of surgery to either lower limb
  • No history of major bony injury to the lower limb such as traumatic fracture, within the past 12 months
  • Presence of chronic lower body running related injuries (e.g., patellofemoral pain, IT band syndrome, Achilles tendinitis, chronic lower back pain after running)
  • Body mass index (BMI) <=35 kg/m2

Exclusion Criteria:

  • Pregnant women
  • < 18 or 65 years
  • BMI >35 kg/m2
  • Mental disablement (down's syndrome or dementia)
  • Any persons incarcerated, on parole, on probation, or awaiting trial.
  • Individuals with neurologic or degenerative musculoskeletal disease, such as rheumatoid arthritis, muscular dystrophy, or Parkinson's disease.
  • Current acute running related or sport related injury (e.g., ankle sprain, hip labral tear, ACL strain during an event or run)
  • Individuals with a history of strong risk factors for poor fracture healing, such as uncontrolled diabetes, chemotherapy, end-stage organ disease, dialysis or smoking
  • Unwilling to forgo your potential in-person therapy visits for a month after enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: paper-based standard care exercise program
Experimental: VPT
Behavioral: VPT
The VPT will be comprised of weekly virtual visits with the participant for one month. During the visits, the physical therapist will review the exercises that were prescribed, adherence, provide feedback to the participant as they execute the exercises onscreen and make corrections, make any progression or adjustments to the exercises, review running cues they learned from the testing session and answer any questions. The therapist will also review any new activities that are initiated during the previous week (to control for confounders), changes in musculoskeletal pain and participation in running volume.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline numerical rating scale for pain (NRSpain) at 4 weeks
Time Frame: Visits 6; one month post enrollment
A numerical rating scale for pain (NRSpain) will be used to assess changes in lower body related musculoskeletal pain at rest (now, average over the last week) and during weight bearing activity (like walking) on a range of lowest score of 0 (no pain) to 10 (worst pain)
Visits 6; one month post enrollment
Change from baseline numerical rating scale for pain (NRSpain) at 6 months
Time Frame: Visits 7; six months post enrollment
A numerical rating scale for pain (NRSpain) will be used to assess changes in lower body related musculoskeletal pain at rest (now, average over the last week) and during weight bearing activity (like walking) on a range of lowest score of 0 (no pain) to 10 (worst pain)
Visits 7; six months post enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline squat quality on single leg (using dominant leg) at 4 weeks
Time Frame: visit 6; one month post enrollment
Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)
visit 6; one month post enrollment
Change from baseline squat quality on single leg (using dominant leg) at 6 months
Time Frame: visit 7; six months post enrollment
Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)
visit 7; six months post enrollment
Change from baseline squat quality on the dual leg at 4 weeks
Time Frame: visit 6; one month post enrollment
Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)
visit 6; one month post enrollment
Change from baseline squat quality on the dual leg at 6 months
Time Frame: visit 7; six months post enrollment
Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)
visit 7; six months post enrollment
Change from baseline standing stork quality (using dominant leg) at 4 weeks
Time Frame: visit 6; one month post enrollment
Balance performance on the standing stork will be scored on the ranges of excellent to poor scale compared to the normative data published for males/females (Schell & Leelarthaepin 1994)
visit 6; one month post enrollment
Change from baseline standing stork quality (using dominant leg) at 6 months
Time Frame: visit 7; six months post enrollment
Balance performance on the standing stork will be scored on the ranges of excellent to poor scale compared to the normative data published for males/females (Schell & Leelarthaepin 1994)
visit 7; six months post enrollment
Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 4 weeks
Time Frame: visit 6; one month post enrollment
A markerless motion system will be used. Cameras will be used to collect the backward-forward displacement during 20 sec of static standing on both legs will be analyzed for ability to control static balance.
visit 6; one month post enrollment
Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 6 months
Time Frame: visit 7; six months post enrollment
A markerless motion system will be used. Cameras will be used to collect the backward-forward displacement during 20 sec of static standing on both legs will be analyzed for ability to control static balance.
visit 7; six months post enrollment
Change from baseline gait speed at 4 weeks
Time Frame: visit 6; one month post enrollment
Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]
visit 6; one month post enrollment
Change from baseline gait speed at 6 months
Time Frame: visit 7; six months post enrollment
Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]
visit 7; six months post enrollment
Change from baseline displacement of the center of gravity in vertical direction at 4 weeks
Time Frame: visit 6; one month post enrollment
Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)
visit 6; one month post enrollment
Change from baseline displacement of the body in vertical direction at 6 months
Time Frame: visit 7; six months post enrollment
Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)
visit 7; six months post enrollment
Change from baseline displacement between strides at 4 weeks
Time Frame: visit 6; one month post enrollment
Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)
visit 6; one month post enrollment
Change from baseline displacement between strides at 6 months
Time Frame: visit 7; six months post enrollment
Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)
visit 7; six months post enrollment
Change from baseline hopping quality (using dominant leg) at 4 weeks
Time Frame: visit 6; one month post enrollment
Quality performance on the hopping three times (using dominant leg) and land on the same limb as far as possible will be scored based on the distance hopped, measured at the level of the great toe on a range of scale 1 (best performance) to 3 (worst performance)
visit 6; one month post enrollment
Change from baseline hopping quality (using dominant leg) at 6 months
Time Frame: visit 7; six months post enrollment
Quality performance on the hopping three times (using dominant leg) and land on the same limb as far as possible will be scored based on the distance hopped, measured at the level of the great toe on a range of scale 1 (best performance) to 3 (worst performance)
visit 7; six months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharareh Sharififar, PhD, PT, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202301005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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