Outpatient Floor Pedal Bike Utilization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Floor Pedal Bike with Guided Instructions for Home.
- Who it may be relevant to
- Registry conditions: Femur Fracture, Tibia Fracture, Ankle Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Return to Work/Functional Activity [Time frame: Baseline, 3, 6, 12 months]
Secondary outcome measures (10)
- Connor-Davidson Resilience Scale (CD-RISC) [Time frame: Baseline, 3, 6, 12 months]
- Tampa Scale for Kinesiophobia (TSK) [Time frame: Baseline, 3, 6, 12 months]
- Pain Catastrophizing Scale (PCS) [Time frame: Baseline, 3, 6, 12 months]
- Veterans RAND 12 Item Health Survey (VR-12) [Time frame: Baseline, 3, 6, 12 months]
- PROMIS Pain Interference Short Form [Time frame: 3, 6, 12 months]
- PROMIS Physical Function Short Form [Time frame: 3, 6, 12 months]
- Brief Pain Inventory (BPI) [Time frame: 3, 6, 12 months]
- Performance test - Timed up and go test [Time frame: 3, 6, 12 months]
- Performance test - Five time sit to stand test [Time frame: 3, 6, 12 months]
- Performance test - 10 meter walk test (Gait) [Time frame: 3, 6, 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06586190 · IRB00101617