Clinical trial NCT05994833: Virtual Physical Therapy Support for Runners
Official title: Virtual Physical Therapy Support for Runners Receiving Gait Analyses for Lower Body Running Related Musculoskeletal Issues
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Musculoskeletal Complication
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline numerical rating scale for pain (NRSpain) at 4 weeks
timeFrame: Visits 6; one month post enrollment
measure: Change from baseline numerical rating scale for pain (NRSpain) at 6 months
timeFrame: Visits 7; six months post enrollment
Secondary outcomes:
measure: Change from baseline squat quality on single leg (using dominant leg) at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline squat quality on single leg (using dominant leg) at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline squat quality on the dual leg at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline squat quality on the dual leg at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline standing stork quality (using dominant leg) at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline standing stork quality (using dominant leg) at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline hopping quality (using dominant leg) at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline hopping quality (using dominant leg) at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline displacement in forward-backward direction during 20 sec of static standing position at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline gait speed at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline gait speed at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline displacement of the center of gravity in vertical direction at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline displacement of the body in vertical direction at 6 months
timeFrame: visit 7; six months post enrollment
measure: Change from baseline displacement between strides at 4 weeks
timeFrame: visit 6; one month post enrollment
measure: Change from baseline displacement between strides at 6 months
timeFrame: visit 7; six months post enrollment
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of medicine- Dept of PM&R
state: Florida
Study officials:
affiliation: University of Florida
name: Sharareh Sharififar, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: