Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
10 Meter Shuttle Run (seconds) |
The 10 meter shuttle run is a well-established timed measure of speed (seconds). There are two lines 10 meters about from each other, the participant starts at one line and two blocks are sitting at the second line. Participants are instructed to retrieve both blocks and move them behind the starting line as quickly as they safely can. Smaller scores indicate faster times to complete the test and are considered better. |
Baseline |
|
| Other |
Self Selected Walking Velocity (m/s) |
SSWV will be assessed using the timed 10 meter walk test where participants are asked to walk 10 meters at a comfortable self-selected pace (m/s). Participants are timed as they cross the middle 6 meters of the distance (the timer is started when they cross a mark 2 meters from the start line and is stopped once they cross a mark 8 meters from the start line). Smaller scores indicate a shorter time, therefore a faster self selected walking velocity, and are considered better. |
Baseline |
|
| Other |
Ankle Range of Motion (degrees) |
Participants completed a biomechanical gait analysis session. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle. Smaller range of motion is expected with each CDO. |
Baseline |
|
| Primary |
PROMIS Physical Function |
The Patient Reported Outcome Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater physical function than the population average. Larger scores are better. |
Baseline |
|
| Primary |
PROMIS Pain Interference |
The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater pain interference than the population average. Lower scores are better. |
Baseline |
|
| Primary |
OPUS Satisfaction with Device and Services |
Satisfaction with device and services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device and Services Score (11-55). Lower scores indicate a better outcome and more satisfaction with the CDO and accompanying services. |
Baseline |
|
| Primary |
Modified Socket Comfort Score - Comfort |
Participants were asked to rate the comfort of each CDO configuration on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable. Higher scores indicate more comfortable conditions, and are considered better. |
Baseline |
|
| Primary |
Modified Socket Comfort Score - Smoothness |
Participants were asked to rate the smoothness of each CDO configuration on a scale from 0-10 with 0 = most smooth to 10 = least smooth. Lower scores indicate smoother conditions, and are considered better. |
Baseline |
|
| Primary |
Numerical Pain Rating Scale |
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable. Lower scores are considered better. |
Baseline |
|
| Primary |
Preference - Ranked |
The participant will be asked to rank order the conditions they have completed testing for at each visit: at the 3rd visit they will rank order their preference for using no orthosis or using the CDO in the first configuration, at the 4th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, and using the CDO in the second configuration, at the 5th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, using the CDO in the second configuration, and using the CDO in the third configuration. |
Baseline |
|
| Primary |
Preference - CDO Configuration |
For each CDO configuration, participants will be asked to rank their preference on a scale from 0 (least preferred) to 10 (most preferred) for a number of questions concerning CDO use. Higher scores indicate higher preferences and are considered better. |
Baseline |
|
| Primary |
Four Square Step Test (seconds) |
The 4SST (seconds) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can. Lower times indicate faster completion of the test and are considered better results. |
Baseline |
|
| Primary |
Sit to Stand 5 Times (seconds) |
STS5 (seconds) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible. Lower scores indicate a faster time to complete the test and are considered better results. |
Baseline |
|
| Primary |
Center of Pressure Velocity Magnitude (m/s) |
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The magnitude of the peak center of pressure velocity (m/s) is the fastest the CoP moves during gait. |
Baseline |
|
| Primary |
Center of Pressure Velocity Timing (%stance) |
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The timing of the peak center of pressure velocity, is the percent of the stance phase (%stance) where the CoP is moving fastest during gait. |
Baseline |
|
| Primary |
Ankle Zero Moment Crossing (%stance) |
The ankle zero moment crossing is the point during the stance phase of gait (%stance) where the ankle moment transitions from a dorsiflexion to a plantarflexion moment. |
Baseline |
|
| Primary |
Peak Ankle Dorsiflexion (degree) |
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait. |
Baseline |
|
| Primary |
Peak Ankle Plantarflexion Moment (Nm/kg) |
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint plantarflexion moment normalized to participant body weight (Nm/kg) that occurs late in the stance phase of gait. |
Baseline |
|
| Primary |
Peak Ankle Push-Off Power (W/kg) |
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint power normalized to body weight (W/kg) occurs late in the stance phase of gait. |
Baseline |
|
| Secondary |
PROMIS Satisfaction with Participation in Social Activities |
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater participation in social activities than the population average, larger scores are considered better. |
Baseline |
|
| Secondary |
PROMIS Satisfaction with Participation in Discretionary Social Activities |
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater participation in discretionary social activities than the population average, larger scores are considered better. |
Baseline |
|
| Secondary |
PROMIS Depression |
The Patient Reported Outcome Information System (PROMIS) depression Computer Adaptive Test (CAT) is a computerized assessment measuring depression. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater levels of depression than the population average, lower scores are considered better. |
Baseline |
|
