Virtual Physical Therapy Support for Runners

Musculoskeletal Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994833
• Other study ID #: IRB202301005
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: June 2030

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: Sharareh PhD, PT
• Phone: 3522738453
• Email: sharareh75[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: June 2030
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Complication

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida College of medicine- Dept of PM&R	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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