Outpatient Floor Pedal Bike Utilization

NCT ID: NCT06586190

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2028-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Observational Arm

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.

Group Type: OTHER

Floor Pedal Bike with Guided Instructions for Home

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients >18 years of age
• Operative fractures of the femur, tibia and select ankle injuries
• Under the care of an orthopaedic surgeon
• English or Spanish competent
• 12 month follow up

Exclusion Criteria

• Type IIIB/C fracture
• Unable to provide consent/need for an LAR
• Major lower extremity peripheral nerve injury (ex. foot drop, sciatic nerve palsy, etc)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Central Contacts

Christine Churchill, MA

Role: CONTACT

christine.churchill@atriumhealth.org

704-355-6947

Rachel B Seymour, PhD

Role: CONTACT

Rachel.Seymour@atriumhealth.org

704-355-6969

Other Identifiers

IRB00101617

Identifier Type: -

Identifier Source: org_study_id