Femur FractureNCT06586190
Outpatient Floor Pedal Bike Utilization
A study testing Floor Pedal Bike with Guided Instructions for Home in people with Femur Fracture and Tibia Fracture, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Tibia Fracture, Ankle Injuries
- What is being tested?
- Floor Pedal Bike with Guided Instructions for Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Femur Fracture, Tibia Fracture, Ankle Injuries
- Being tested
- Floor Pedal Bike with Guided Instructions for Home
- Keywords
- floor pedal bike, lower extremity, rehabilitation
- Medical subject headings
- Femoral Fractures, Tibial Fractures, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floor Pedal Bike with Guided Instructions for HomeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Observational Arm | Other | 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. Receives: Other: Floor Pedal Bike with Guided Instructions for Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3, 6, 12 months
Secondary outcomes (10)
Connor-Davidson Resilience Scale (CD-RISC)
Scores range between 0-100. Higher scores indicate higher resilience.
Measured: Baseline, 3, 6, 12 months
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
Measured: Baseline, 3, 6, 12 months
Pain Catastrophizing Scale (PCS)
Scores range between 0-52. A higher score indicates a greater degree or pain catastrophizing.
Measured: Baseline, 3, 6, 12 months
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.
Measured: Baseline, 3, 6, 12 months
PROMIS Pain Interference Short Form
Scores range from 8 to 40. A higher score indicates greater pain interference.
Measured: 3, 6, 12 months
PROMIS Physical Function Short Form
T-scores range from 14.1 to 61.7. T-scores of 14.1-30.0 represent severe impairment, 30.0-40.0 represent moderate impairment, 40.0-45.0 represent mild impairment, and 45.0-61.7 indicate no impairment
Measured: 3, 6, 12 months
Brief Pain Inventory (BPI)
The BPI is a commonly used and validated 15-item measure of pain intensity and interference with daily life. Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Measured: 3, 6, 12 months
Performance test - Timed up and go test
Participants begin in a seated position. They are directed to stand and walk 3 meters to a cone on the floor. They are to round the cone in a continuous motion, walk back to the chair, turn again and be seated. The entire test is performed at a comfortable and safe speed for the patient. The data are captured by an Attitude and Heading Reference System (AHRS). Custom software has been developed to appropriately filter the raw data, establish a fixed global coordinate system (i.e. aligned with the body coordinate system), segregate gait segment data from turn data, and delineate and compile data for left and right strides for separate analyses.
Measured: 3, 6, 12 months
Performance test - Five time sit to stand test
Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist. The test pattern is repeated 5 times. The data are captured by an Attitude and Heading Reference System (AHRS) that is chest-mounted and positioned at the top of the sternum using a simple harness. Custom software has been developed to appropriately filter the raw data, establish a fixed global coordinate system (i.e. aligned with the body coordinate system), segregate gait segment data from turn data, and delineate and compile data for left and right strides for separate analyses.
Measured: 3, 6, 12 months
Performance test - 10 meter walk test (Gait)
Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject. The data are captured by an Attitude and Heading Reference System (AHRS) that is chest-mounted and positioned at the top of the sternum using a simple harness. Custom software has been developed to appropriately filter the raw data, establish a fixed global coordinate system (i.e. aligned with the body coordinate system), segregate gait segment data from turn data, and delineate and compile data for left and right strides for separate analyses.
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586190
- Sponsor's protocol ID
- IRB00101617
- Status last verified
- May 2026
- First submitted
- 3 Sep 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Floor Pedal Bike Utilization
- ClinicalTrials.gov ID
- NCT06586190
- Acronym / sponsor ID
- IRB00101617
- Conditions
- Femur Fracture, Tibia Fracture, Ankle Injuries
- Keywords
- floor pedal bike, lower extremity, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Arm | Other | Other: Floor Pedal Bike with Guided Instructions for HomePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Floor Pedal Bike with Guided Instructions for HomePatients 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. | Other | Observational Arm |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Hsu, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Floor Pedal Bike with Guided Instructions for Home in people with Femur Fracture and Tibia Fracture, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Churchill, MA (704-355-6947, christine.churchill@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to Work/Functional Activity (time frame: Baseline, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.