Outpatient Floor Pedal Bike Utilization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Floor Pedal Bike with Guided Instructions for Home
Other interventionPatients 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 groups
20 Participants
are divided into 1 treatment groupGroup A: Observational ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Return to Work/Functional Activity
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
Time frame
Baseline, 3, 6, 12 monthsSecondary outcomes
1
Connor-Davidson Resilience Scale (CD-RISC)
Scores range between 0-100. Higher scores indicate higher resilience.
Time frame
Baseline, 3, 6, 12 months2
Tampa Scale for Kinesiophobia (TSK)
This scale is 17 items and uses a 4-point Likert scale ranging from 'strongly disagree' to 'strongly agree'. The TSK is a validated measure for surgical and musculoskeletal patients. The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia
Time frame
Baseline, 3, 6, 12 months3
Pain Catastrophizing Scale (PCS)
Scores range between 0-52. A higher score indicates a greater degree or pain catastrophizing.
Time frame
Baseline, 3, 6, 12 months4
Veterans RAND 12 Item Health Survey (VR-12)
Patients will complete the Veterans RAND 12 Item Health Survey (VR12).The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame
Baseline, 3, 6, 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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