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NCT Number: NCT05994833

Virtual Physical Therapy Support for Runners

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.

Recruiting

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Key information

Conditions

Musculoskeletal Complication

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida College of medicine- Dept of PM&R

Gainesville, Florida, 32607, United States

Location status: Recruiting

Location contact

Sharareh Sharififar, PhD, PT

CONTACT

[email protected]

352-273-8453

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VPT

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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.

  10. 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.

  11. 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)]

  12. 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)]

  13. 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)

  14. 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)

  15. 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)

  16. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sharareh PhD, PT

CONTACT

[email protected]

3522738453

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Aug 16, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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