Outpatient Floor Pedal Bike Utilization

Wake Forest University (WFU)

Status: Begins enrollment in 1 month

Conditions: Tibia Fracture; Femur Fracture; Ankle Injuries

Treatments: Other: Floor Pedal Bike with Guided Instructions for Home

Study type: Interventional

Funder types: Other

Identifiers

NCT06586190

IRB00101617

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Observational Arm

Other group

Description:

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.

Treatment:

Other: Floor Pedal Bike with Guided Instructions for Home