Outpatient Floor Pedal Bike Utilization

Browse trials for

• Femoral Fractures 186
• Tibial Fractures 135
• Ankle Injuries 350

Keywords

• floor pedal bike
• lower extremity
• rehabilitation

Femoral Fractures

186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.

This study's planned enrollment of 20 is below the median of 61 across 114 interventional studies indexed under Femoral Fractures.

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Study arms

• 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

Interventions

• OtherFloor 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.

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 months

Secondary outcomes

1. Connor-Davidson Resilience Scale (CD-RISC)

   Scores range between 0-100. Higher scores indicate higher resilience.

   Time frame: Baseline, 3, 6, 12 months

2. 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 months

3. 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 months

4. 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 months

5. PROMIS Pain Interference Short Form

   Scores range from 8 to 40. A higher score indicates greater pain interference.

   Time frame: 3, 6, 12 months

6. 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

   Time frame: 3, 6, 12 months

7. 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.

   Time frame: 3, 6, 12 months

8. 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.

   Time frame: 3, 6, 12 months

9. 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.

   Time frame: 3, 6, 12 months

10. 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.

    Time frame: 3, 6, 12 months