An interventional study of SoftHand Pro and Ossur i-Limb in Upper Extremity Injury, Upper Extremity Deformities, Congenital and Amputation, Traumatic, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
A trial to compare the performance of the SoftHand Pro (SHP) and Ossur i-Limb in people with transradial limb loss over an 8-week period.
This study will measure improvements in outcomes obtained from laboratory testing of the SHP and i-Limb from baseline to after 8 weeks of daily use. A secondary analysis will incorporate the subjects' existing prosthetic hands. Finally, surveys and usage data collected through the SHP and i-Limb firmware during daily use will complement data the aforementioned outcomes to explore factors that may be related to differences in grasping and manipulation performance.
63 studies on the registry are indexed under Arm Injuries; 10 are open to participants now.
This study's enrollment of 36 is below the median of 55 across 44 interventional studies indexed under Arm Injuries.
Browse Arm Injuries studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm of the crossover design will begin the trial using the SoftHand Pro.
Device: SoftHand Pro · Device: Ossur i-Limb
This arm of the crossover design will begin the trial using the i-Limb.
Device: SoftHand Pro · Device: Ossur i-Limb
Performance assessments utilizing the SoftHand Pro over an 8-week period.
Performance assessments utilizing the i-Limb over an 8-week period.
Upper Extremity Functional Ability [1]
Change in upper extremity function, as measured by the Activities Measure for Upper Limb Amputees (AM-ULA). Participants complete 17 tasks, rated on task completion, speed of completion, movement quality, skillfulness of prosthesis use, and independence from the use of other assistive devices or adaptive environments with the prosthesis. The scale is 0 to 4, with a higher number representing higher performance in each category. Scores in each category are averaged for a Grade in each task. Grades for the 17 tasks are averaged and multiplied by 40 for a final score of 0 - 40, with a higher number representing higher overall function.
Time frame: 8 Weeks
Upper Extremity Functional Ability [2]
Change in upper extremity function, as measured by the Action Research Arm Test (ARAT). Participants perform up to 19 tasks categorized by grasp, grip, pinch, and gross movement. The scale is 0 to 3, with a higher number representing higher performance in each category. Categories are scored separately.
Time frame: 8 Weeks
Upper Extremity Manual Dexterity
Change in upper extremity gross manual dexterity, as measured by the Box and Blocks test. Participants are tested in a timed transfer of blocks from one side of a box to another side over a low partition. A higher number of blocks successfully transferred during the timed episode represents a higher level of upper extremity manual dexterity.
Time frame: 8 Weeks
Hand Motor Function
Change in fine and gross motor hand function, as measured by the Jebsen-Taylor Hand Function Test. Participants are timed in seven activities of daily living closely involving use of the hand, with a lower number of seconds required to complete the task representing a higher level of motor hand function.
Time frame: 8 Weeks
Occupational Performance
Change in participants' perceived occupational performance, as measured by the Canadian Occupational Performance Measure (COPM). Participants choose up to 5 occupational performance problems; their perception of their own performance and their satisfaction with their performance regarding each problem is measured on a 1 to 10 scale, with higher scores representing higher performance and satisfaction. The difference in performance and satisfaction is calculated, and then the differences for all problems together are totaled and averaged, with the average divided by the number of problems establishing the final score for each performance and satisfaction. Higher averages represent better perceived performance and satisfaction.
Time frame: 8 Weeks
Quality of Life
Change in participants' perceived quality of life, as measured by the the World Health Organization Quality of Life Disabilities Module (WHOQOL-DIS). Participants answer qualitative questions regarding patient activities, independence, and overall quality of life on a 1 to 5 scale, with a higher number indicating a higher concurrence or frequency related to the item in question, and totaled for a score which categorizes patient quality of life.
Time frame: 8 Weeks
Upper Extremity Function and Pain
Change in participants' perceived levels of upper extremity physical function and symptoms, as measured by the Disabilities of the Arm, Shoulder, and Hand Score (QuickDASH). Participants rate their difficulty with examples of physical function and their severity of physical symptoms on a 1 to 5 scale, with higher values representing more severe difficulties and symptoms. The scores are combined in a calculation which results in an overall score, with higher scores representing more severe overall difficulties and symptoms.
Time frame: 8 Weeks
Overall Functional Performance
Change in participants' perceived functional performance, as measured by the Patient-Specific Functional Scale. Participants select 5 or more activities for which they perceive a problem, rating their own performance of that activity on a scale of 0 to 10, with higher values representing greater ability to perform the activity. The scores are totaled and divided by the number of tasks for an average score, with higher values representing better performance.
Time frame: 8 Weeks
Prosthesis Overall Functional Utility
Change in participants' perception of the utility of their currently-used prosthesis, as measured by the Orthotics Prosthetics Users Survey - Upper Extremity Functional Status (OPUS). Participants rate the prosthetic's ease of use for a variety of daily activities, 23 of which are scored, on a 0 to 4 scale, with higher values representing easier use. Scores are totaled and converted to a 0 to 92 scale, with higher overall scores representing better functional utility with the prosthesis.
Time frame: 8 Weeks
Arm Pain
Change in participants' levels of pain is measured for subjects who have pain due to brachial plexopathy or neuropathy. A visual analog pain scale (VAS) specific to the limb testing the experimental device will be administered prior to, and after, the clinical measures. The VAS scale is measured by the subject's own perspective by using a 0 to 10 scale, with zero indicating no pain and ten being intolerable pain. These baseline metrics will be compared with performance metrics obtained using the same tests delivered at the end of the daily-use period.
Time frame: 8 Weeks
Prosthesis User Preference
Changes in participants' perception of the utility, functional performance, ergonomics, and ease of use of their currently-used prosthesis, as measured by a custom Active Use questionnaire. Participants rate the extent to which they agree to 12 to 14 statements (depending of which prosthesis) on a 1 to 10 scale, with higher ratings representing closer agreement. Individual statements are assessed separately (no overall score).
Time frame: 8 Weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2022 to primary completion in Apr 2026, 47 months.
Of 28 non-industry interventional studies with no phase under Arm Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 47 months is above that.
Counting every sponsor, half of 28 studies reached it within 24 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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