Virtual Physical Therapy Support for Runners

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: Recruiting
• Conditions: Musculoskeletal Complication
• Intervention / Treatment: Behavioral: VPT

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharareh PhD, PT; Phone Number: 3522738453; Email: sharareh75@ufl.edu
• Study Contact Backup: Name: Jamie Bolliong; Phone Number: 3522737412; Email: jamiekbolling@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • Recruiting
      • University of Florida College of medicine- Dept of PM&R
      • Contact: Sharareh Sharififar, PhD, PT; Phone Number: 352-273-8453; Email: sharareh75@ufl.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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.	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.	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)]	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)]	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)	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)	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)	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)	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)	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)	visit 7; six months post enrollment

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Sharareh Sharififar, PhD, PT, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID 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