Condition: Amputation · Upper Limb · Sponsor: Infinite Biomedical Technologies
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.
This description comes directly from the study's public registry record.
Rahul R Kaliki, Ph.D · (443) 451-7175 · rahul@i-biomed.com
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| Advanced Arm Dynamics | Redondo Beach, California, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06539936