Musculoskeletal ComplicationNCT05994833
Virtual Physical Therapy Support for Runners
A study testing VPT in people with Musculoskeletal Complication, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Complication
- What is being tested?
- VPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to Jun 2030
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
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
University of Florida College of medicine- Dept of PM&R
Gainesville, Florida, 32607
Sharareh Sharififar, PhD, PT, 352-273-8453, sharareh75@ufl.edu
About this study
Official title: 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.
- Conditions
- Musculoskeletal Complication
- Being tested
- VPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| paper-based standard care exercise program | No intervention | Not described |
| VPT | Experimental | Not described Receives: Behavioral: VPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline numerical rating scale for pain (NRSpain) at 4 weeks
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)
Measured: Visits 6; one month post enrollment
Change from baseline numerical rating scale for pain (NRSpain) at 6 months
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)
Measured: Visits 7; six months post enrollment
Secondary outcomes (16)
Change from baseline squat quality on single leg (using dominant leg) at 4 weeks
Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)
Measured: visit 6; one month post enrollment
Change from baseline squat quality on single leg (using dominant leg) at 6 months
Squat performance on the single leg (using dominant leg) will be scored on a range of scale 1 (best performance) to 3 (worst performance)
Measured: visit 7; six months post enrollment
Change from baseline squat quality on the dual leg at 4 weeks
Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)
Measured: visit 6; one month post enrollment
Change from baseline squat quality on the dual leg at 6 months
Squat performance on the dual leg will be scored on a range of scale 1 (best performance) to 3 (worst performance)
Measured: visit 7; six months post enrollment
Change from baseline standing stork quality (using dominant leg) at 4 weeks
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)
Measured: visit 6; one month post enrollment
Change from baseline standing stork quality (using dominant leg) at 6 months
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)
Measured: visit 7; six months post enrollment
Change from baseline hopping quality (using dominant leg) at 4 weeks
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)
Measured: visit 6; one month post enrollment
Change from baseline hopping quality (using dominant leg) at 6 months
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)
Measured: visit 7; six months post enrollment
Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 4 weeks
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.
Measured: visit 6; one month post enrollment
Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 6 months
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.
Measured: visit 7; six months post enrollment
Change from baseline gait speed at 4 weeks
Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]
Measured: visit 6; one month post enrollment
Change from baseline gait speed at 6 months
Spatiotemporal parameters are analyzed [i.e. gait speed (meters/sec), cadence (steps/minute)]
Measured: visit 7; six months post enrollment
Change from baseline displacement of the center of gravity in vertical direction at 4 weeks
Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)
Measured: visit 6; one month post enrollment
Change from baseline displacement of the body in vertical direction at 6 months
Spatiotemporal parameters are analyzed (i.e. center of gravity vertical displacement measured in centimeters)
Measured: visit 7; six months post enrollment
Change from baseline displacement between strides at 4 weeks
Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)
Measured: visit 6; one month post enrollment
Change from baseline displacement between strides at 6 months
Spatiotemporal parameters are analyzed (i.e. stride width measured in centimeters)
Measured: visit 7; six months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start10 Aug 2023
- Primary completionAug 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ComplicationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharareh Sharififar, PhD, PT, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994833
- Sponsor's protocol ID
- IRB202301005
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Physical Therapy Support for Runners Receiving Gait Analyses for Lower Body Running Related Musculoskeletal Issues
- ClinicalTrials.gov ID
- NCT05994833
- Acronym / sponsor ID
- IRB202301005
- Conditions
- Musculoskeletal Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 16 Aug 2023 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paper-based standard care exercise program | No intervention | – |
| VPT | Experimental | Behavioral: VPT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| VPTThe 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. | Behavioural | VPT |
Primary outcome
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)
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)
16 secondary outcomes
Change from baseline squat quality on single leg (using dominant leg) at 4 weeks
Time frame: 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
Change from baseline squat quality on the dual leg at 4 weeks
Time frame: 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
Change from baseline standing stork quality (using dominant leg) at 4 weeks
Time frame: 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
Change from baseline hopping quality (using dominant leg) at 4 weeks
Time frame: 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
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
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
Change from baseline gait speed at 4 weeks
Time frame: visit 6; one month post enrollment
Change from baseline gait speed at 6 months
Time frame: 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
Change from baseline displacement of the body in vertical direction at 6 months
Time frame: visit 7; six months post enrollment
Change from baseline displacement between strides at 4 weeks
Time frame: visit 6; one month post enrollment
Change from baseline displacement between strides at 6 months
Time frame: visit 7; six months post enrollment
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 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Complication
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
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.
Sharareh Sharififar, PhD, PT principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VPT in people with Musculoskeletal Complication, run by University of Florida 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 6 inclusion and 9 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 15 May 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 Sharareh PhD, PT (3522738453, sharareh75@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline numerical rating scale for pain (NRSpain) at 4 weeks (time frame: Visits 6; one month post enrollment). The study lists 2 primary outcomes in all. 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 15 May 2026.