Outpatient Floor Pedal Bike Utilization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 20
- Primary Endpoint
- Return to Work/Functional Activity
Study Overview
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:
- to test the feasibility of identifying patients and getting patients the floor pedal bikes themselves
- 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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Floor Pedal Bike with Guided Instructions for Home (Other)
Outcomes
Primary Outcomes
Return to Work/Functional Activity
Time Frame: Baseline, 3, 6, 12 months
The primary assessment tool will be the International Physical Activity Questionnaire. IPAQ measures the total amount of physical activity completed in a 7 day period by calculating the minutes per week in in each physical activity level domain (walking, moderate and vigorous) by a metabolic equivalent energy (MET) expenditure estimate. Walking = 3.3 x number of walking minutes x number of walking days Moderate activity= 4.0 x number activity minutes x number of days Vigorous activity = 8 x number of activity minutes x number of days Total = Walking MET-min/wk+moderate MET-min/wk+vigorous MET-min/wk
Secondary Outcomes
- Connor-Davidson Resilience Scale (CD-RISC)(Baseline, 3, 6, 12 months)
- Tampa Scale for Kinesiophobia (TSK)(Baseline, 3, 6, 12 months)
- Pain Catastrophizing Scale (PCS)(Baseline, 3, 6, 12 months)
- Veterans RAND 12 Item Health Survey (VR-12)(Baseline, 3, 6, 12 months)
- PROMIS Pain Interference Short Form(3, 6, 12 months)
- PROMIS Physical Function Short Form(3, 6, 12 months)
- Brief Pain Inventory (BPI)(3, 6, 12 months)
- Performance test - Timed up and go test(3, 6, 12 months)
- Performance test - Five time sit to stand test(3, 6, 12 months)
- Performance test - 10 meter walk test (Gait)(3, 6, 12 months)