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Arm Dynamics, FDA Examine Prosthetic Rehabilitation Outcomes

by Betta Ferrendelli
October 13, 2021
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Arm Dynamics, Redondo, California, and the US Food and Drug Administration (FDA) published two peer-reviewed, open-access research papers based on outcome measure data collected at Arm Dynamics. The papers examine how patient-reported and performance-based assessments correlate and what factors impact the perceived function of people who wear an upper limb prosthesis.

“Most prosthetic providers use a stand-alone, patient-reported survey to measure the outcome of a patient’s upper-limb prosthetic rehabilitation because it doesn’t require a dedicated clinician to collect the data,” said John Miguelez, CP, FAAOP (D), president and senior clinical director at Arm Dynamics. “Our collaborative research with the FDA makes it clear that adding a performance-based outcome measure results in a more complete and accurate view of each patient’s progress with a prosthesis.”

The studies present national data that was compiled using existing outcome measures and two population-specific outcome measures created by Arm Dynamics.

“The research illuminates the need to examine both a patient’s perceived function and actual function,” said Kerstin Baun, MPH, OTR/L, national director of therapeutic services at Arm Dynamics. “Capturing this complementary data allows us to make key shifts during the rehabilitation process that can directly increase long-term success with a device.”

The first study included 101 patients fitted with an upper-limb prosthesis. Each completed a patient-report outcome measure to help determine what factors most influence the person’s perception of their prosthetic function. The most statistically significant factors were satisfaction, pain, and amputation level. The second study included 61 patients who were in the definitive stage of prosthesis fitting. Each completed one patient-report and two performance-based outcome measures.

The study “Understanding the Relationship Between Patient-Reported Function and Actual Function in the Upper Limb Prosthesis User Population: A Preliminary Study,” was published in Science Direct. “Factors influencing perceived function in the upper limb prosthesis user population,” was published in PM&R: The Journal of Injury, Function and Rehabilitation.

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