Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses
NCT Number: NCT06539936
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Amputation|Upper Limb
Interventions: DEVICE: Glide|DEVICE: Direct Control
Sponsor: Infinite Biomedical Technologies
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|Advanced Arm Dynamics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2026-03-31
Locations: Advanced Arm Dynamics, Redondo Beach, California, 90277, United States

Summary:
The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.

This study will compare the use of Glide \[Experimental\] prosthesis with a DC \[Standard\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.

Primary Outcome Measures: 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., Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161 and Day 168)
Secondary Outcome Measures: 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., Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168)|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., Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168)|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., Daily (i.e., Day 0, Day 1, Day 2, ..., Day 167, Day 168)|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., Daily (i.e., Day 0, Day 1, Day 2, ..., Day 167, Day 168)|FIT Survey, The FIT Survey allows the provider to maximize each patient's comfort, performance, and wear time for uninterrupted use for the life of their prosthesis. After limb loss, the shape and volume of a patient's residual limb will fluctuate throughout their life, potentially impacting comfort, wear time and prosthetic performance. The FIT Survey identifies a patient's residual limb changes in 4 key domains through a low-burden patient reported outcome measure taken every 3 months as a standard of care at Arm Dynamics. Reviewing the Fit Survey weekly during the 24-week research project will allow the clinical team to identify any changes in fit of the prosthesis and immediately address them so that the variables of fit and performance on study results are mitigated., Weekly (i.e., Day 0, Day 7, Day 14, ..., Day 161, and Day 168)|Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a subject-report outcome measure (PROM) developed as a measure of perceived disability in those with upper extremity musculoskeletal disorders. The DASH consists mainly of a 30-item disability/symptom items rated on a 5-point Likert scale, with totals scored 0 (no disability) to 100. It has been validated for the upper limb amputee population., Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168)|Speed and Accuracy Measurement, A Speed and Accuracy Measurement (SAM) will be administered as a simple measurement to identify consistency and accuracy of accessing different components or grasp patterns, as well as speed. This measurement asks the subject to access two predetermined grip patterns OR from access hand then wrist and back 10 times (timed, number of accurate switches out of 10)., Baseline (i.e., Day 0); Post-Intervention (i.e., Day 35/42/49, Day 70/84/98, Day 119/126/133, and Day 168)