Clinical trial NCT06586190: Outpatient Floor Pedal Bike Utilization
Official title: Outpatient Floor Pedal Bike Utilization
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Femur Fracture
Tibia Fracture
Ankle Injuries
Keywords: floor pedal bike
lower extremity
rehabilitation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Return to Work/Functional Activity
timeFrame: Baseline, 3, 6, 12 months
Secondary outcomes:
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline, 3, 6, 12 months
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline, 3, 6, 12 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 3, 6, 12 months
measure: Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: Baseline, 3, 6, 12 months
measure: PROMIS Pain Interference Short Form
timeFrame: 3, 6, 12 months
measure: PROMIS Physical Function Short Form
timeFrame: 3, 6, 12 months
measure: Brief Pain Inventory (BPI)
timeFrame: 3, 6, 12 months
measure: Performance test - Timed up and go test
timeFrame: 3, 6, 12 months
measure: Performance test - Five time sit to stand test
timeFrame: 3, 6, 12 months
measure: Performance test - 10 meter walk test (Gait)
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: