Outpatient Floor Pedal Bike Utilization

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Injuries; Femur Fracture; Tibia Fracture
• Intervention / Treatment: Other: Floor Pedal Bike with Guided Instructions for Home

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Churchill, MA; Phone Number: 704-355-6947; Email: Christine.Churchill@advocatehealth.org
• Study Contact Backup: Name: Rachel B Seymour, PhD; Phone Number: 704-355-6969; Email: Rachel.Seymour@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 3, 6, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connor-Davidson Resilience Scale (CD-RISC)	Scores range between 0-100. Higher scores indicate higher resilience.	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	Baseline, 3, 6, 12 months
Pain Catastrophizing Scale (PCS)	Scores range between 0-52. A higher score indicates a greater degree or pain catastrophizing.	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.	Baseline, 3, 6, 12 months
PROMIS Pain Interference Short Form	Scores range from 8 to 40. A higher score indicates greater pain interference.	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	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.	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.	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.	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.	3, 6, 12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Joseph Hsu, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; lower extremity; floor pedal bike
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Femoral Fractures; Tibial Fractures; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Nursing Services; Home Care Services
• Other Study ID Numbers: IRB00101617

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No