From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

PROMIS Physical Function

时间窗: Baseline

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.

Preference - Ranked

时间窗: Baseline

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.

OPUS Satisfaction with Device and Services

时间窗: Baseline

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.

PROMIS Pain Interference

时间窗: Baseline

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.

Modified Socket Comfort Score - Comfort

时间窗: Baseline

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.

Modified Socket Comfort Score - Smoothness

时间窗: Baseline

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.

Four Square Step Test (seconds)

时间窗: Baseline

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.

Sit to Stand 5 Times (seconds)

时间窗: Baseline

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.

Peak Ankle Plantarflexion Moment (Nm/kg)

时间窗: Baseline

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.

Peak Ankle Push-Off Power (W/kg)

时间窗: Baseline

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.

Numerical Pain Rating Scale

时间窗: Baseline

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.

Preference - CDO Configuration

时间窗: Baseline

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.

Center of Pressure Velocity Magnitude (m/s)

时间窗: Baseline

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.

Center of Pressure Velocity Timing (%stance)

时间窗: Baseline

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.

Ankle Zero Moment Crossing (%stance)

时间窗: Baseline

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.

Peak Ankle Dorsiflexion (degree)

时间窗: Baseline

Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait.