Virtual Physical Therapy Support for Runners

NCT05994833 | Recruiting

• 1 other identifier: IRB202301005
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Visits 7; six months post enrollment

Secondary Outcomes (16)

• Change from baseline squat quality on single leg (using dominant leg) at 4 weeks

  visit 6; one month post enrollment

• Change from baseline squat quality on single leg (using dominant leg) at 6 months

  visit 7; six months post enrollment

• Change from baseline squat quality on the dual leg at 4 weeks

  visit 6; one month post enrollment

• Change from baseline squat quality on the dual leg at 6 months

  visit 7; six months post enrollment

• Change from baseline standing stork quality (using dominant leg) at 4 weeks

  visit 6; one month post enrollment

Study Arms (2)

paper-based standard care exercise program

NO INTERVENTION

VPT

EXPERIMENTAL

Behavioral: VPT

Interventions

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.

VPT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

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

Gainesville, Florida, 32607, United States

RECRUITING

Study Officials

• Sharareh Sharififar, PhD, PT

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharareh PhD, PT

CONTACT

3522738453; sharareh75@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: August 16, 2023
• Study Start: August 10, 2023
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: January 29, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)