NCT06586190

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 29, 2026

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

September 3, 2024

Last Update Submit

April 28, 2026

Conditions

Femur FractureTibia FractureAnkle Injuries

Keywords

floor pedal bikelower extremityrehabilitation

Outcome Measures

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

    Baseline, 3, 6, 12 months

Secondary Outcomes (10)

  • Connor-Davidson Resilience Scale (CD-RISC)

    Baseline, 3, 6, 12 months

  • Tampa Scale for Kinesiophobia (TSK)

    Baseline, 3, 6, 12 months

  • Pain Catastrophizing Scale (PCS)

    Baseline, 3, 6, 12 months

  • Veterans RAND 12 Item Health Survey (VR-12)

    Baseline, 3, 6, 12 months

  • PROMIS Pain Interference Short Form

    3, 6, 12 months

  • +5 more secondary outcomes

Study Arms (1)

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.

Other: Floor Pedal Bike with Guided Instructions for Home

Interventions

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.

Observational Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • month follow up

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Femoral FracturesTibial FracturesAnkle Injuries

Interventions

Home Care Services

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Officials

  • Joseph Hsu, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Churchill, MA

CONTACT

704-355-6947christine.churchill@atriumhealth.org

Rachel B Seymour, PhD

CONTACT

704-355-6969Rachel.Seymour@atriumhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 29, 2026

Record last verified: 2025-06