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

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline

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.

Time frame: Baseline