Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses

Comprehensive Arm Prosthesis and Rehabilitation Outcomes Questionnaire (CAPROQ)

CAPROQ is a validated patient reported outcome measure that captures key facets of rehabilitation for adults with UL absence or loss: perceived function, satisfaction, and pain. CAPROQ includes a total of 28 questions spread across three sub-scales: 8 satisfaction, 10 perceived functioning, and 10 pain subcategory questions. Responses to all questions are given on a 10-point, Likert-type scale. Higher scores therefore indicate higher levels of overall satisfaction. A singular total CAPROQ score is derived by standardizing each of the CAPROQ subscales and summing these standardized scores together. Higher total scores on the CAPROQ indicate better rehabilitation outcomes and reflect the individual's perceived success with their prosthesis and rehabilitation; specifically, satisfaction with their prosthesis and rehabilitation, greater functional performance, and lesser pain. CAPROQ scores range from 0 to 100.

Capacity Assessment of Prosthesis Performance of the Upper Limb (CAPPFUL)

CAPPFUL is a validated outcome measure designed as a versatile, low-burden measure of prosthesis performance for any UL functional prosthetic device type and any UL amputation level. CAPPFUL assesses overall performance and 5 functional performance domains during completion of 11 tasks. These require movement in all planes while manipulating everyday objects requiring multiple grasp patterns. Performance domains include control skill, adaptive and maladaptive compensatory movement, component utilization and time for task completion. CAPPFUL scores range from 0 to 100.

Targeted Box and Blocks Tests (tBBT)

tBBT allows for analysis of movement initiation, grasp, transport, and controlled release of objects. Participant performance in the tBBT is quantified by task completion time. A box with two compartments is used for this assessment. The blocks are arranged in a 4x4 array on the side of the testing hand, using an insert as a guide. Block colors and shapes are correlated to four different grip types available in prosthetic hands. Participants will be instructed to transport one block at a time, starting with the block closest to the partition in the row closest to the participant, placing the blocks in the mirrored position on the opposite side of the partition into target locations defined by an identical insert as on the side of the testing hand. The participant's score will be the time it takes to transport all 16 blocks. Administrators will also keep track of those blocks that are considered unsuccessful transports. tBBT scores start from 0 with no maximum value.

Daily Mean Number of Movement Bouts (DMNMB)

DMNMB is an objective measure collected by the controller. The controller does not send any outputs to the prosthesis when the control is in a "rest" state. For all other outputs, movement commands are sent to the prosthesis. Thus, the controller is in a good position to be able to record the amount of prosthesis usage as measured by the frequency of control signals. Such activity is measured in terms of series of continuous movement commands called "movement bouts." The number and length of movement bouts will be recorded and stored in the controller memory. Participants will report DMNMB weekly using a web-based portal.

Mean Prosthesis Wear Duration (MPWD)

MPWD measures the mean duration of daily prosthesis wear as a proxy for improved prosthesis acceptance. Prosthesis wear time is defined as the time from when subjects don their prostheses to the time they doff their prostheses and is self-reported by the participant. The log will be provided through a web-based portal and will be filled out weekly, each entry providing the prosthesis wear duration of the previous week.