NCT06586190

Outpatient Floor Pedal Bike Utilization

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goals of this clinical trial are: to test the feasibility of identifying patients and getting patients the floor pedal bikes, to test how well floor pedal bikes help patients with lower body injuries heal, and to test methods of patient self-reported logs for home pedal bike use. Participants will be given a floor pedal bike at first post-operative appointment where weightbearing restrictions are lifted (weight-bearing as tolerated) along with instructions on utilization. Participants will be asked to complete patient reported outcome measure surveys at each follow-up visit.

Detailed description

The goals of this clinical trial are: 1. to test the feasibility of identifying patients and getting patients the floor pedal bikes themselves 2. to test the efficacy of floor pedal bikes in the rehabilitation of patients with lower extremity orthopedic trauma injuries without formal physical therapy or as a supplement to preexisting and/or future physical therapy. We hope that these bikes will either supplement patient's preexisting therapy or allow them to complete therapy at home if they are unable to obtain formal physical therapy and 3. to test various methods of patient self-reported logs for home pedal bike utilization, whether electronic or hard paper copy. Participants will be given a floor pedal bike at first post-operative appointment where weightbearing restrictions are lifted (weight-bearing as tolerated) along with instructions on utilization. Participants will be asked to complete patient reported outcome measure surveys at each follow-up visit.

Conditions

• Femur Fracture
• Tibia Fracture
• Ankle Injuries

Interventions

Type	Name	Description
OTHER	Floor Pedal Bike with Guided Instructions for Home	Patients with lower extremity traumatic injuries that are medically clear for physically ready for therapy and will receive a floor pedal bike with guided exercises at home.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-09-19
• Last updated: 2026-02-04