Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
PROMIS Patient reported outcomes for pain behavior |
The Patient Reported Outcome Information System (PROMIS) pain behavior Computer Adaptive Test (CAT) is a computerized assessment measuring pain behavior. 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 more of the measured variable than the population average. |
3 months |
|
Other |
PROMIS Patient reported outcomes for 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 more of the measured variable than the population average. |
3 months |
|
Other |
PROMIS Patient reported outcomes for satisfaction with participation in social roles |
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social roles Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social roles. 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 more of the measured variable than the population average. |
3 months |
|
Other |
Satisfaction with services (OPUS - CSS) |
Satisfaction with services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Services Score (10-50). Lower scores indicate a better outcome. |
3 months |
|
Other |
Sit to stand 5 times (STS5 - Timed) |
STS5 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. |
3 months |
|
Other |
Timed Stair Ascent (TSA - Timed) |
The timed stair ascent test is a measure of mobility, agility, and lower limb muscle strength. Participants are instructed to ascend a flight of 12 steps as quickly and safely as possible while contacting every step. |
3 months |
|
Primary |
PROMIS Patient reported outcomes for 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 more of the measured variable than the population average. |
3 months |
|
Primary |
PROMIS Patient reported outcomes for 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 more of the measured variable than the population average. |
3 months |
|
Primary |
Activities-Specific Balance Confidence (ABC) |
The ABC provides a standardized evaluation of balance confidence across a range of common daily tasks. |
3 months |
|
Primary |
Satisfaction with device (OPUS - CSD) |
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome. |
3 months |
|
Primary |
Modified Socket Comfort Score (Comfort) |
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. |
3 months |
|
Primary |
Modified Socket Comfort Score (Comfort and Smoothness) |
Smoothness scores range from 0 = least smooth to 10 = most smooth. |
3 months |
|
Primary |
Numerical Pain Rating Scale |
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. |
3 months |
|
Primary |
Participant device preference |
The participant will rank order their preference for their standard of care device, Reaktiv and Phatbrace on a questionnaire. |
After 3 months of accomodation with the final device (Crossover study) |
|
Primary |
Four-square step test (4SST- Timed) |
The 4SST is a standardized timed test of balance and agility. |
3 months |
|
Primary |
Self-selected walking velocity (SSWV - Timed) |
SSWV will be assessed using the timed 10 meter walk test. |
3 months |
|
Primary |
10 meter shuttle run (10M Shuttle - Timed) |
The 10 meter shuttle run is a well-established timed measure of speed. |
3 months |
|
Primary |
Ankle joint power |
Peak ankle joint moment (W/kg) during gait. |
3 months |
|
Primary |
Center of pressure velocity timing |
Timing of peak center of pressure velocity (percent stance) during gait. |
3 months |
|
Primary |
Center of pressure velocity magnitude |
Magnitude of peak center of pressure velocity (m/s) during gait. |
3 months |
|
Secondary |
PROMIS Patient reported outcomes for 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 more of the measured variable than the population average. |
3 months |
|
Secondary |
Paffenbarger Physical Activity Questionnaire |
Participants will report their activity using the Paffenbarger Physical Activity Questionnaire. Time spent in each activity category will be recorded. |
3 months |
|
Secondary |
Ankle joint moment |
Peak ankle joint moment (Nm/kg) during gait. |
3 months |
|