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The Centers for Disease Control and Prevention estimate that almost 2 million people in the U.S. use an orthotic device like a knee, ankle or foot orthosis to assist them with balance, walking or navigating stairs. The users are almost evenly divided among children, adults and the elderly; many of them have conditions that affect their ability to walk or stand. The root cause of the problem may be transitory, like a fracture or bad sprain, but it could also be related to a longer-lasting medical condition such as stroke, traumatic brain injury, multiple sclerosis or Parkinson’s disease.
While some orthoses are prefabricated, some patients require a custom-made device. In that case, orthotists make plaster casts of the patient’s limb and craft the orthosis to fit as well as possible. Despite the interest in measuring medical outcomes and improving quality of care throughout the U.S. health-care system, there are few specific instruments to measure how effective such devices are and how users feel about the process of receiving one. Orthotists and physical therapists, who work with patients to help them get the most out of these devices, have told researchers that they wished they had better ways to measure the outcomes of their efforts. 嫩B研究院ers at the Center for Rehabilitation Outcomes 嫩B研究院 (CROR) at the Shirley Ryan 嫩B研究院 took up that challenge in 2016 with a $1.5 million, three-year grant from the U.S. Department of Defense.
It could involve the efficiency of delivery of the device or the coordination of care with other clinicians.
Stefania Fatone, PhD
Body
A research team, headed by CROR Director Allen Heinemann, PhD, had searched for measurement instruments that assess the quality of care and outcomes of custom ankle-foot orthosis (AFO) care. They found few of them. Instead, orthotists and physical therapists often use measures created for other purposes. The researchers wanted to identify what those were and find out whether they might be effective in measuring AFO quality of care.
During a systematic literature review, the team found 16 instruments that had been used in four or more studies about AFOs. They took those articles to an advisory committee made up of orthotic users, clinicians and representatives of various professional and patient advocacy organizations. The committee whittled the pile down to five measures that were “broadly suitable” for use with people who were receiving AFO care. All five were activity-based measures such as the Berg Balance Scale and the Timed Up and Go test, which measures mobility.
But none of those looked at the overall experience of orthotic care, which includes fitting the device, physical therapy to prepare for using it and other factors such as wait times for delivery. “Most of what was measured was the function people had. That’s important but it doesn’t span the spectrum of the process,” says Stefania Fatone, PhD, an orthotist and co-investigator on the study who also is a professor in the Department of Physical Medicine and Rehabilitation at Northwestern University’s Feinberg School of Medicine. “Everything that comes before needs to be measured as well. It could involve the efficiency of delivery of the device or the coordination of care with other clinicians. There could be a situation where the device works well but the patient is dissatisfied because they are disenchanted with the process.” To get at the quality-of-life aspect of orthotic care, the researchers identified two patient-reported outcome measures that would be good additions to a standardized battery of tests. They included OPUS CSD, (the Orthotic and Prosthetic Users’ Survey of Client Satisfaction with Device), a self-report questionnaire with five modules developed by Heinemann and CROR; and QUEST 2.0 (The Quebec User Evaluation of Satisfaction with Assistive Technology).
The researchers planned to test the battery of measures with 100 AFO users who were evenly divided between new users and those who had their devices for some time. Participants were recruited at three sites: the Shirley Ryan 嫩B研究院 in Chicago, Hines VA Hospital in Maywood, Illinois, and the Minneapolis VA Medical Center in the Twin Cities. Working through orthotists and physical therapists, it was relatively easy to identify current AFO users but the team found recruiting new users to be particularly challenging. “You’re talking about people who have just had a stroke or some other kind of trauma, and you’re asking them to deal with one more thing,” Fatone points out. “It’s just a really difficult population to enroll, and COVID didn’t do us any favors.”
The conceptual part is done and we’ve shown how quality of care can be operationalized within our context
Stefania Fatone, PhD
Body
With their access to hospital patients restricted by the pandemic, the researchers reduced their target of 100 study participants to 80 and realized that about three-quarters of the group would be made up of current users. The current users had two rounds of walking assessments a week apart, measuring both speed and distance. New users made three assessment visits spread over three months, walking with and without their AFO. They also filled out the satisfaction surveys.
As of late May 2021, the mean age of new users who participated was about 60 and 44% of them were female. They also had a body mass index score of about 30, which classified them as moderately obese. If the AFOs of the new users were beneficial, the researchers expected to see improvements in both speed and endurance over the three visits. And they did.
Among people who had been using an AFO for some time, the average age was about the same and 49% were women but their BMI was just under 28, which classified them as overweight. If the devices were working well, the researchers expected to see consistent performance in terms of speed and endurance, and that also happened. One of the veterans who participated in the study was so fast on his feet that Hines VA project manager Ibuola Kale had to run down the hall to keep up with him with her stopwatch and measurement wheel.
Because of the COVID-related interruptions, the study’s data collection was still ongoing in the spring of 2021, putting the project in its second year of a no-cost extension. But the researchers hope to have things wrapped up in the fall. “We certainly are going to deliver and we never expected this to be the end point of the discussion,” says Fatone. “The conceptual part is done and we’ve shown how quality of care can be operationalized within our context.”