Parents say comfort, easy use are clubfoot compliance keys

The dynamic AFO used in the Swedish study (above), provides a durable low-intensity stretch to the Achilles tendon and medial soft tissues, and can be worn unilaterally. (Photo courtesy MD Orthopaedics.)

All devices present challenges

By Hank Black

A recently developed pediatric orthosis for Ponseti night bracing received positive ratings from parents in a small Swedish study of children with idiopathic clubfoot who had compliance problems or relapse with one of two earlier bracing devices, a foot abduction brace (FAB) or a dynamic knee ankle foot orthosis (KAFO).

Noncompliance with the four-year nighttime Ponseti bracing protocol is the principal cause of relapse following initial correction with serial manipulation, casting and, in some cases, Achilles tenotomy. The protocol generally calls for FAB or KAFO wear 23 hours a day for the first three months after final cast removal, and 12 to 14 hours of nighttime wear thereafter.

The study, presented in a poster session at the 16th International Society for Prosthetics and Orthotics (ISPO) World Congress, held May 8 to 11 in Cape Town, South Africa, evaluated parental satisfaction with a dynamic AFO that supports both subtalar and tibiotalar joint functions.

Poster lead author Hanna Steiman-Engblom, CPO, MSc, said, “When we use the dynamic AFO device, it is when there are problems with compliance with the Ponseti bar or KAFO.”

The dynamic AFO simultaneously dorsiflexes and abducts the foot and supports fully functional triplane foot motion. As a night brace, it provides a long-duration, low-intensity stretch to the Achilles tendon and medial soft tissues, and can be worn unilaterally, according to its UK manufacturer.

Investigators placed the 40 parent participants into two groups: those whose children had worn an FAB (n = 13) or those who wore a KAFO (n = 27). All parents completed the 12-item Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) questionnaire to rate satisfaction with the dynamic AFO. They also were asked to choose the three items that were most important for satisfaction.

“Overall, both parental groups evaluated their satisfaction with the device as ‘good,’” said Steiman-Engblom, who noted the study didn’t assess parental satisfaction with the previous braces. “We can’t generalize from the results due to the small sample, of course, but this seems to provide an optional design that may be suitable for relapsed patients,” she said.

Steiman-Engblom is a prosthetist-orthotist in the orthopedic workshop TeamOlmed in Stockholm, Sweden, and conducted her study at the Karolinska Institutet, also in Stockholm.

“Getting parents to maintain years of nighttime bracing is the biggest Ponseti method challenge”
— Raymond Pye

Both parent groups named comfort, effectiveness, and ease of use as the three most important QUEST items. Steiman-Engblom said, “QUEST is generic for assistive devices and not specific for orthoses. If there were a questionnaire specific for orthosis and children the validity would be higher.”

Reasons for noncompliance and recurrence differ to some extent between developed countries like Sweden and less developed areas, say experts like Raymond Pye of Seattle-based nonprofit Mobility Outreach International (MOI).

Those reasons tend to involve cultural issues and clinician-patient communication more than brace design, though patients in less-developed areas could benefit from advanced bracing technology if it were more widely available, Pye said.

Pye is MOI’s director of program quality and emerging programs. He manages the organization’s clubfoot program in Haiti and also monitors FAB manufacturing quality for MOI partners in low-income countries.

He said there are unique challenges in more rural areas, such as when female elders in a village apply social pressure on young parents not to follow a prescribed bracing protocol for their child. “In certain places, there is a kind of group pressure on some parents to take the brace off early,” he said. “The foot may look almost normal after the first month of bracing and the elders or relatives say, ‘See you don’t even need to use the brace, it doesn’t matter.’ But, of course, relapse is slow but steady, and more than ninety percent of clubfoot recurs [when protocols aren’t followed].”

But, in some ways, parents are the same the world over. “I think the time and effort given by clinicians is similar in the US and in emerging nations as they help parents fit their child,” Pye said. “Getting the parents to maintain the nighttime fitting of the brace for three or four years is the biggest challenge in the Ponseti method. Clinicians even in the US tell me they have to remind the parents, literally every time they come in to the clinic, to fit the brace well.”

Pye said it’s difficult to compare the sophisticated device used in the Swedish study with the locally sourced braces MOI uses and teaches the manufacturing of in its grassroots efforts. For one thing, the cost of the former is in at least three figures, while that of the FAB MOI uses can be in the single digits. Advantages of the dynamic AFO, in addition to its high-tech ability to adjust width and degree of shoe angle, he said, include the extra clamping above the ankle which, he said, “would help when a child can’t keep the brace on very well at night.”

Hank Black is a freelance writer in Birmingham, AL.


Steiman-Engblom H, Villiard L. Parental satisfaction with the use of an ADM-device for children with idiopathic clubfoot. Presented at the 16th International Society for Prosthetics and Orthotics World Congress, Cape Town, South Africa, May 11-14, 2017.

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