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. Author manuscript; available in PMC: 2024 Feb 1.
Published in final edited form as: Int J Cardiol. 2022 Nov 29;372:23–32. doi: 10.1016/j.ijcard.2022.11.041

Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework

Ayisha Z Bashir 1, Danae M Dinkel 2, Iraklis I Pipinos 3,4, Paul A Estabrooks 5, Jason M Johanning 3,4, Sara A Myers 1,4
PMCID: PMC9836764  NIHMSID: NIHMS1853710  PMID: 36455699

Abstract

Background:

Peripheral artery disease (PAD) is a cardiovascular disease that limits patients’ walking ability. Persistent ankle-foot orthosis (AFO) use may increase the distance patients can walk as well as physical activity.

Purpose:

The purpose of the study was to determine the implementation and patients’ perspectives related to the use or disuse of the AFO intervention six months post-intervention. This study was guided by a semi-structured interview and survey based on the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) constructs.

Design:

A convergent mixed methods design was used to evaluate participants’ perceptions six months following a three-month AFO intervention. A survey and semi-structured questionnaire based on the i-PARIHS constructs were administered and analyzed.

Setting:

Vascular surgery clinic and biomechanics research laboratory.

Participants:

Patients (N=7; male, 100%; age, 71.9±.6.7y; body mass index, 29.0±.5.5; ankle brachial index 0.50 ± 0.17) with claudication completed the study.

Interventions:

A certified orthotist fit participants with an AFO that was worn for 3 months.

Main Outcome Measures:

Qualitative analysis of semi-structured interviews and quantitative analysis of the survey.

Results:

The highest positive ratings were seen in the dimensions of usability and cost-effectiveness. The patients found the AFO device and instructions to wear, easy when starting the intervention and there were no out-of-pocket costs. The lower scores and challenges faced with observability and relative advantage domains indicated issues related to motivation for sustained use of the AFO.

Conclusions:

Barriers associated with AFO function that prevent common activities and poor health seem to be the biggest issue for not wanting to wear the AFO after the 3-month intervention. Addressing patients’ perceptions and challenges to wearing the AFO is essential to increasing compliance and physical activity. Future research should concentrate on understanding the compatibility of orthotic device interventions with the subject’s lifestyle.

Keywords: Patient-reported outcome measures, peripheral artery disease, ankle-foot orthoses, orthotic devices, i-PARIHS framework

Introduction

Peripheral artery disease (PAD), a manifestation of systemic atherosclerosis characterized by atherosclerotic blockages of the arteries supplying blood to the legs, affects ~236 million people globally [1,2]. PAD is associated with claudication, walking-induced pain in the legs, stemming from insufficient blood flow, and a resulting myopathy that leads to significant gait deficits and prevents normal leg function [1,3]. Increasing the levels of physical activity is shown to improve claudication [1,4]. Research has found that increased physical activity improves walking ability, overall functional status, and health-related quality of life, and decreases the cardiovascular risk for adverse events such as stroke, myocardial infarction, etc. in patients with PAD [1,6]. While it is recommended that adults obtain 10,000 steps/day [4,5]; patients with PAD only accrue an average of 2,651 to 4,737 steps/day [6–8].

Supervised exercise therapy (SET) is the most common non-invasive treatment for this population and is deemed to be highly effective in increasing the distance patients with PAD can walk [6,7]. Studies have shown that six months of SET produced increases in walking distances and quality of life that coincide with improvements in muscle strength and gait biomechanics [8]. There are some issues with compliance with SET due to lack of access to the exercise facility, transportation, conflicts with occupational commitments, family responsibilities, and other barriers [6,8]. SET also does not address muscle weakness or the limited blood flow present in patients with PAD. Assistive devices are being explored as an innovative solution to provide push-off assistance during walking for these patients [9–14]. Assisting the muscles with each step can decrease blood flow demand and prolong the onset of claudication pain [12].

Incorporating an assistive device to support an active lifestyle pattern that prolongs disease progression, appears to be desirable and beneficial for patients with PAD [4,5]. Recent studies elucidate that an AFO may be a helpful tool in attenuating calf claudication symptoms and therefore improving the walking ability of patients with PAD [9,12]. Choma et al used semi-structured interviews to qualitatively analyze patient perspectives related to an AFO intervention; however, no corresponding functional data was captured, and no follow-up assessment was conducted [13,14]. The focus group findings suggest the AFO intervention helped enhance participation in meaningful daily and recreational activities [11–13]. Compared to the previous research, our study is unique as we are assessing six months of post-intervention adherence after the three-month intervention was completed, which to our knowledge has not been explored before [11,12]. This study provides some evidence needed to improve assistive device adherence in general and post-intervention [10]. The information gained from our research could also be used to improve the AFO and future assistive device interventions [10,11,12]. For an AFO to improve walking performance and quality of life, increase physical activity, and decrease cardiovascular risk in patients with PAD, patients must regularly wear the device [9, 11–13,14]. The patients only attain the benefits if they are compliant with the intervention [9,12].

One conceptual framework used to facilitate the implementation of innovations into healthcare practices is the integrated-Promoting Action on Research Implementation in Health Sciences (i-PARIHS) framework. The i-PARIHS framework has been used previously in individuals with chronic diseases like diabetes to improve intervention adherence [16]. Utilizing i-PARIHS can provide insight into the factors contributing to the use or disuse of the intervention [15,16].

The purpose of the study was to use a mixed-method approach designed to determine long-term adherence and patients’ perspectives of an AFO six months post-intervention to investigate if they were still using the device after the 3-month intervention was completed [17].

1. Methods

A convergent mixed-methods approach was utilized to achieve the objectives of this study [18]. In this triangulation design, quantitative data from surveys were collected with the addition of qualitative data from semi-structured interviews to supplement and validate the findings [18]. This study was approved by the Institutional Review Board at the Nebraska-Western Iowa Veteran Affairs(VA) Medical Center. All subjects were provided informed consent prior to participation and the study protocol conforms to the ethical guidelines of the 1975 Declaration of Helsinki.

2.1. Constructs from the i-PARIHS framework

The Integrated Promoting Action on Research Implementation in Health Sciences (i-PARIHS) framework provided insight into AFO compatibility, the potential for adoption, and barriers and facilitators of maintenance [15]. The integrated PARIHS framework focuses on the characteristics of implementation, which depends on the interplay of recipient, facilitation, context, and innovation [15,16]. Please see Appendix A and B for the survey and questionnaire. The guiding questions used in our study are based on the sub-elements from the innovation construct which are defined in Table 1.

Table 1.

Definitions of the i-PARIHS constructs used for mixed-methods analysis[15].

Constructs from i-PARIHS framework Definition
 Compatibility The degree of fit (of the assistive device) with existing practice and values.
 Usability /complexity The perceived feasibility and difficulty of implementation of the assistive device.
 Relative advantage The need for innovation (assistive device).
 Trialability The extent to which the assistive device can be tried on a limited basis.
 Observability/ Observable results The extent to which the results of the assistive device intervention will be observable to others.
 Cost-effectiveness The costs related to the intervention and those associated with implementation, including investment, supply, and opportunity.
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2.2. Study Design and Patients

This study was part of a larger crossover design protocol examining the effects of an AFO on walking performance in patients with PAD. Additional details on the full protocol can be found elsewhere[19]. Inclusion criteria were: 1) to be able to give written, informed consent; 2) demonstrate a positive history of chronic claudication; 3) demonstrate exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon; 4) have an ankle/brachial index <0.90 at rest; and 5) have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks. Exclusion criteria were: 1) rest pain or tissue loss due to PAD (Fontaine stage III and IV); 2) acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma; and 3) walking capacity limited by conditions other than claudication, including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.

Patients with PAD were recruited from an established vascular surgery clinic and consented to wear an AFO for 3 months. A certified orthotist fit each subject with 1 of the 2 carbon-fiber AFOs (Trulife, Ottobock) after the clinical evaluation. A subset of those patients who had previously completed the original trial and had consented to participate in the six-month follow-up study was included in this subsequent study.

1.3. Data Collection

The subjects shared their perspectives of the AFO via surveys and semi-structured interviews based on the constructs of the i-PARIHS framework [15]. Data were assessed for patients’ perceptions related to positive and negative implications as well as barriers and facilitators to AFO use. The survey and interviews were administered 6 months after intervention completion via telephone. Semi-structured qualitative interviews lasting no longer than 30 minutes were conducted by the first author. The first author introduced herself to the participants and took notes. Two participants were contacted again as they were unable to participate in the interview and survey initially due to time constraints. The semi-structured interviews and surveys were audio recorded.

Self- administered survey (instrument)

The 28-item self-administered survey was developed based on the constructs of the i-PARIHS framework by the lead author and an i-PARIHS expert [16,20]. The survey assessed implementation as described by the innovation construct in the domains of trialability, cost-effectiveness, observability, relative advantage, usability, and compatibility factors affecting the ease/difficulty of use via a 5-point Likert-type agreement scale: (ranging from 1= strongly disagree to 5=strongly agree).

The survey was piloted with a few subjects to ensure completion was not burdensome and questions were understood. Participants took approximately 10 minutes to complete the survey and were asked to report any clarification needed to the lead author, no alterations were needed. Pilot testing took place in the lab in which doors were closed after the end of the data collection protocol with only IRB- approved study personnel present.

Semi-structured interviews

The semi-structured interview guide included 22 open-ended interview questions and was also developed utilizing the same constructs of i-PARIHS as the survey: trialability, low cost, observability, relative advantage, usability, and compatibility [15–16,20]. The interview aimed to gather in-depth information affecting the ease/difficulty of use to determine the evidence and context of implementation. Interview questions were pilot tested with the first few participants, who found the questions easy to comprehend and no adjustments were needed.

1.4. Data Analysis

Microsoft Excel 2019 worksheets were used to store and organize survey data. The survey data were entered into the Statistical Package for the Social Sciences (SPSS v28.0). Descriptive statistics were conducted to compare the domains of trialability, cost-effectiveness, observability, relative advantage, usability, and compatibility.

The semi-structured interviews were transcribed and analyzed by the research team in NVivo 12 using a directed content analysis approach based on the i-PARIHS framework [21]. The researcher independently coded transcripts to reach major data themes. Emerging themes were identified by constant comparison. This approach allowed for the development of explanations through patterns but also allowed the coder to harness theory and prior knowledge to answer research questions [21].

First, the lead author read through the transcripts several times to familiarize herself with the data. Initial parent codes were developed using a deductive approach which develops codes utilizing existing theory or frameworks by following the i-PARIHS framework [15,16, 21]. After the coding was complete, a codebook was developed to establish a definition for each code. The codebook and codes were shared with the second author, who is trained to perform qualitative data analysis and has more than a decade of experience. The co-author reviewed all codes according to the codebook. Any coding discrepancies were discussed until a consensus was reached to generate the validity of the qualitative data and report our findings [22]. Data were validated through the process of peer debriefing and interviewing to saturation. We utilized the Standards for Reporting of Qualitative Research [22], the best practices guideline, or the criteria for reporting qualitative research (COREQ) [Appendix C] [23].

2. Results

Nine participants from the original study consented to be contacted 6 months after study completion [9]. However only seven participants were included in the study as two participants were unable to continue (one passed away and the other had a terminal illness). All seven participants were male, with an average age of 71.9 years (SD = 6.7) and a body mass index of 29.0 (SD = 5.5; )[Table 2].

Table 2.

Patient demographics and baseline characteristics

Characteristics Mean ± standard deviation(baseline)
   No. of patients 7
   Male 100%
   Age, years 71.9 ± 6.60
Body mass index, kg/m2 29.24 ± 5.70
Ankle-brachial index 0.50 ± 0.17
   Smoking
   Current 71.40 %(5/7)
   Former 28.57% (2/7)
   Never None
   Comorbidities
Coronary artery disease 71.40%(5/7)
   Diabetes 42.86% (3/7)
   Dyslipidemia 71.4% (5/7)
   Hypertension 100%(7/7)
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Two patients withdrew from the study before completion due to health reasons. Hence interview data and surveys were collected from 7 subjects that completed the intervention [Table 2].

3.1. Surveys

The highest scores were in the usability (4.3 /5) and the cost-effectiveness domains (4.0/5) while the lowest scores were recorded in relative advantage (2.0/5). This indicated the AFO was not complex to wear and as the VA paid for the device and services related to the intervention, there were no out-of-pocket expenses or costs due to wearing the AFO (Tables 3 a and b). Only one subject was still wearing the AFO after the intervention finished while the others had returned the AFO (6/7) (observability). In the construct of compatibility, participants mentioned difficulty while climbing stairs and driving (6/7).

Table 3(a).

Survey questions and patient responses

Constructs Questions Median response
1. Trialability  1. I enjoyed the steps to get started wearing the AFO 4.2
a.  2. I was comfortable wearing the AFO from the beginning. 3.0
b.  3. The fitting of the AFO was easy 4.2
c.  4. In my opinion the fitting of the AFO did not need improvement 3.2
2.Relative Advantage  5. The AFO has advantages compared to other things that I have tried to improve PAD or help me walk more 2.0
a.  6. I have previously participated in other health programs to help me walk more 1.0
b.  7. The AFO worked better than other things I tried to help me be more physically active 3.0
3. Usability  8. I was able to wear the AFO device when I began the study 4.3
a.  9. It was easy for me to put on the AFO when I started wearing it 4.2
b.  10. I was able to understand how to wear the AFO when I got it 4.3
4.Usability  11. The orthotist visit was easy 5.0
a.  12. In my opinion the orthotist visit did not need improvement 4.0
b.  13. The instructions I got from the orthotist were easy to follow 4.0
5.Compatability  14. The AFO fits well with my lifestyle 3.0
a.  15. The AFO is helping me with my daily activities 2.8
b.  16. The ability to wear the AFO made it easy to fit into my routine 3.0
6.Compatability  17. I liked my experiences with AFO personnel 3.5
a.  18. I liked my experiences with the research team 5.0
b.  19. I liked my experiences with the orthotist 5.0
c.  20. I liked the support I got from the health care providers related to the AFO 5.0
7.Observability  21. I could see my progress from wearing the AFO 3.7
a.  22. I had success wearing the AFO 3.2
b.  23. It was easy for me to know if I was successful wearing the AFO. 2.7
c.  24. People I know could see the progress I made with the AFO 3.4
8. Cost-effectiveness  25. Even though the AFO was free, I had no new out of pocket costs from the program 4.0
a.  26. Participating in the AFO intervention did not change my out-of-pocket costs 5.0
b.  27. I saved money by wearing the AFO 3.5
9. Relative advantage  28. To be successful, the time I needed to wear the AFO was enough 3.0
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3.2. Semi-Structured interviews

AFO patient interviews:

Table 4 provides an overview of the study findings by i-PARIHS constructs.

Table 3(b).

Ratings of each i-PARIHS dimension(Interquartile range-IQR).

Dimension Median(IQR)
Usability 4.3(0.3)
Cost-effectiveness 4.0 (1.5)
Compatibility 3.6(2.0)
Trialability 3.6(1.1)
Observability 3.2(0.6
Relative Advantage 2.0(1.5)
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Interventions other than AFO (relative advantage).

Postintervention all but one subject was trying other things to improve walking. Two subjects recently had surgery and mentioned: that “the surgery will help in improving pain and walking”. Three subjects were planning to try tennis shoes as part of another study to see if they would help while walking. Scooters provided by the VA were being used by two subjects. Subjects said the scooters were helpful while grocery shopping and pursuing other activities out of the house. One subject mentioned, “I am using a scooter to avoid the pain while walking”.

Challenges to wear (compatibility).

The challenges reported most often were in relation to wearing the AFO while they were doing daily activities throughout their house or around their home. This included climbing stairs, walking to the mailbox, and/or driving their car. For example, a subject mentioned due to deterioration in his health and progression of his PAD symptoms, he had issues wearing the AFO. He mentioned “My health. I guess driving is difficult with them. Going up and downstairs is really difficult because I can’t bend my foot”. Participants also mentioned it takes time to get used to the AFO “ it’s an extra effort”. As one subject mentioned, “I didn’t have time to put them on, took time to get comfortable, I am not used to wearing something extra on my foot. It is hard to wear the brace and the shoes, it took forever”. Health problems were a barrier to some as one subject mentioned “It was easy before my leg started hurting bad”.

Perceived ease to use at the beginning (usability).

None of the participants reported needing help while wearing the AFO as most found it was easy to put on in the beginning. A subject mentioned, “It was easy to use, and I still wear it”.

Ability to walk better (observability).

Participants reported the AFO helped them in walking better, especially, when they first started using the AFO and that they had less pain while walking. As one subject mentioned,” I can walk down to my garage and back now. I couldn’t before these braces due to pain”.

Out of pocket cost.

Participants reported they had not had any out-of-pocket costs due to wearing the AFO.

Trialability.

All of the participants reported they tested the AFO before use.

3. Discussion

This study explored differences in patient perspectives using the i-PARIHS constructs for the implementation of an AFO intervention. Previous research has found that interventions and innovations with higher relative advantage, usability, and observability, according to the theoretical frameworks, are more likely to be adopted [29–37].

Results of the survey indicated the highest and most positive rating was seen in the usability and the low-cost dimension. The patients found the AFO intervention and instructions easy to follow when starting the intervention and appreciated the lack of costs. All subjects reported that there were no out-of-pocket expenses or costs due to wearing and receiving the AFO. Some devices were donated (Ottobock) while others were purchased by grant funds; additionally, services related to the intervention were free of charge at the VA hospital. Six months post-intervention only one subject was wearing the AFO which shows lower adherence compared to our previous study in which 15 out of 21 subjects were wearing the AFO and 6 subjects withdrew from the study before the three-month intervention was completed [10]. This subject did not report any barriers to wearing the AFO; while the other subjects reported more barriers and were not consistent in adhering to the intervention on a daily basis [10,14].

Responses from the trialability domain indicated all of the participants mentioned they were able to test the AFO when they began the intervention and were satisfied with the orthotic fitting of the AFO. None had tried an assistive device intervention before this study; however, once the 3-month intervention was over 2 subjects had surgery (2/7) and 2 other subjects started using a scooter to help with mobility. Relative advantage and observability received the lowest scores in the survey. In interviews, we did see that only one participant had not tried or did not want to try other interventions (surgery, scooter, tennis shoes) besides the AFO. The responses from the survey were further supported by the interview responses (Tables 3 and 4).

In line with our previous study, the results of this post-intervention study indicate patients have barriers wearing the AFO such as driving and climbing stairs that made them choose not to wear the AFO after the intervention was completed [14]. Unfortunately, many of the patients health in the current study had deteriorated which made wearing the AFO more uncomfortable and an added chore when they felt burdened by their ill-health and progressing leg pain. Some benefits of the intervention were found in the construct of cost and usability in all patients (Table 3). Similar to our previous study, patients mentioned positive aspects of the AFO, including ease in standing and walking, as well as walking straighter and longer with less pain[10]. The current study expands these findings showcasing that even three months after the intervention they remembered these positive impacts, despite the fact that most had discontinued wearing the AFO[10,14]. To help address comfort issues, during the intervention comfortable shoes were provided to the patients and all 7 participants in this study adhered to wearing the shoes along with the AFO during the intervention. They found it easy to follow the instructions to wear the AFO. However, once the three-month intervention was completed, they wanted to try something else, except one subject who was still wearing the AFO. It is possible that training and patient education could optimize AFO use and help patients meet functional goals while using the AFO [10–12]. While some of the issues that these patients experience might not be resolved, it is important to assess the long-term feasibility of wear for those who completed the intervention. This subset of preliminary data from the AFO intervention provides important insights for assessing the overall feasibility of the intervention.

4. Conclusions

The degree of the fit of the AFO with the subject’s lifestyle and activities of daily living seems less compatible, despite finding it easy to don/doff. The i-PARIHS constructs helped analyze patient responses and perceptions through survey data and semi-structured interviews. Barriers associated with AFO function that prevent common activities (stairs, driving) and poor health seem to be the biggest issue for not wanting to wear the AFO after the 3-month intervention.

5. Future Directions and Limitations

Future research should concentrate on new assistive devices that leverage the positive aspects of the AFO intervention, costs covered by insurance, ease of use, and comfort while walking, and address the barriers that prevented long-term adoption [38]. Administration of a baseline survey program developed from the i-PARIHS framework would be insightful, particularly when compared to a post-intervention assessment [29–30,36–37], which we were unable to administer in our study. The small sample size is a limitation of our study due to IRB protocol restrictions. Participants in this study had stopped using the AFO during or after the intervention. Due to the length of time between when they had been wearing the AFO, this may have induced recall bias related to the AFO intervention. The characteristics of patients who continued from those who stopped using the AFO in the previous study were similar to as reported before as they belong to the same demographic[10,14]. The barriers were also similar to as reported before, therefore their memory seems to be reporting accurately [10,14].

In addition, our study was limited to only two types of AFO in one type of (Veteran patient) the male population. Future researchers should consider conducting similar studies in a diverse population with walking impairments to explore the long-term adherence to assistive devices in patients with PAD.

Suppliers

  1. Ottobock, LLC.

  2. Trulife.

  3. NVivo 12; QSR International Pty.

  4. SPSS version 28; IBM.

Table4.

Constructs, salient semi-structured questions, and patient responses.

Constructs/themes based on i-PARIHS AFO interview questions Patient statement/answers
Relative advantage Have you heard of other things that could help and how does the AFO compare? “They did help when I started wearing them and my health is worse now, so they got me the scooter. I use the scooter a lot.”
Compatibility How well did wearing the AFO fit with your lifestyle? “They’re a bit tedious with some stair steps and a bit tedious while driving but nothing I can’t handle. I wear them every day, but I only do it for about 15 minutes at night when I use the treadmill.”
Usability (Barriers: Physical discomfort and Poor health) Tell me about anything that made it (makes it) harder to use your AFO? “It cuts the inside of my foot. Yeah, I could try them more often, they still hurt my feet a lot. Going up and downstairs is really difficult because I can’t bend my ankle”.
“I’ve had some medical problems and I’ve been in the hospital…I pretty much stopped wearing them.”
Observability What were some of the benefits you could see from wearing the
AFO?		 “But yeah, the walking I can go a little bit further with these on. So, they do help. And plus, ya know, they do help me stand up straight. And uh, I can walk straighter”.
“It seems to help me walk a little better and feels more comfortable to walk.”
Cost-effectiveness What changes, if any, in your out-of-pocket cost were associated with wearing the AFO? “I had no extra cost with these braces…they took care of it”.
Trialability Tell me about when you first tried the AFO. Were you able to test it out a little bit before you decided to use it? “Oh yes, when I started using it, it wasn’t bad.”.
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Highlights.

  • Chronic peripheral artery disease causes muscle weakness that impairs walking.

  • An ankle-foot orthosis may improve the distance patients with peripheral artery disease can walk.

  • 6 months post-intervention questionnaire assessments were based on i-PARIHS framework

Acknowledgments

We thank the Department of Biomechanics, University of Nebraska, and Team Myers for their help and support.

FUNDING SOURCES AND CONFLICTS OF INTEREST

Supported by the National Institutes of Health (grant nos. RO1AG034995 and RO1HD090333), Veteran Affairs (Merit grant no. I01 RX003266) United States Department of Veterans Affairs Rehabilitation Research and Development Service (va.gov), and Graduate Research and Creative Activity 2020-2021 grant.

List of abbreviations:

AFO

ankle-foot orthosis

PAD

peripheral artery disease

SET

supervised exercise therapy

i-PARIHS

integrated-Promoting Action on Research Implementation in Health Sciences

COREQ

criteria for reporting qualitative research

APPENDIX

Appendices

Appendix A Study Survey Questions- For Ankle foot Orthosis (AFO)

Study Survey Questions- For Ankle foot Orthosis (AFO)

Please indicate how much you agree or disagree with each of the following statements:

Strongly disagree Some what disagree Neitheragreenor disagree Some what agree Strongly agree
1. I enjoyed the steps to get started wearing the AFO. (trialability) 2 3 4 5
a. I was comfortable wearing the AFO from the beginning 2 3 4 5
b. The fitting of the AFO was easy 2 3 4 5
c. In my opinion the fitting of the AFO could be improved 2 3 4 5
2. The AFO has advantages compared to other things that I have tried to improve PAD or help me walk more. (Relative advantage) 2 3 4 5
a. I have previously participated in other health programs to help me walk more. 2 3 4 5
b. The AFO worked better than other things I tried to help me be more physically active 2 3 4 5
3. I was able to wear the AFO device when I began the study(usability) 2 3 4 5
a. It was easy for me to put on the AFO when I started wearing the AFO 2 3 4 5
b. I was able to underst and how to wear the AFO when I got it 2 3 4 5
4. The orthoti stvisit was easy(usability) 2 3 4 5
a. In my opinion the orthotist visit needed no improvement 2 3 4 5
b. The instructions I got from the orthotist were not complex 2 3 4 5
5. The AFO fits well with my lifestyle. (compatibility) 2 3 4 5
a. The AFO is helping me with my daily activities 2 3 4 5
b. The ability to wear the AFO made it easy to fit into my routine 2 3 4 5
6. I liked my experiences with AFO(support personnel compatibility) 2 3 4 5
a. I liked my experiences with the research team 2 3 4 5
b. I liked my experiences with the orthotist 2 3 4 5
c. I liked the support I got from the health care providers related to the AFO 2 3 4 5
7. I could see my progress from wearing the AFO(observability) 2 3 4 5
a. I had success wearing the AFO 2 3 4 5
b. It was easy for me to know if I was being successful wearing the AFO 2 3 4 5
c. Peo ple I know could see the progress I made with the AFO 2 3 4 5
8. Even though the AFO was free, I had no new out of pocket costs from the program (lowcost) 2 3 4 5
a. Participating in the AFO intervention did not change my out of pocket costs. 2 3 4 5
b. I saved money by wearing the AFO. 2 3 4 5
9. To be successful, the time I needed to wear the AFO was enough (compatibility) 2 3 4 5
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Appendix B. Guiding Questions:

  1. (trialability). Tell me about when you first tried the AFO. Were you able to test it out a little bit before you decided to use it?
    1. Do you have any suggestions about how you might help someone else get started with an AFO?
  2. (usability) How easy is/was the AFO to use?
    1. Tell me about anything that made it (makes it) harder to use your AFO?
    2. Can you tell me about any changes to the AFO that would make it easier to use?
    3. How long did it take you until you felt comfortable using the AFO?
    4. Do you need help while putting it on?
  3. (compatibility) How well did wearing the AFO fit with your lifestyle?
    1. How much of a change in your routine did wearing the AFO demand?
    2. What were some of the situations when you felt like wearing the AFO wasn’t a priority for you?
    3. What were some of the emotions you experienced when integrating wearing the AFO into your life?
      1. Calming – Exciting – Mundane – Frustrating - Stressful
    4. What did people in your life think about you using an AFO?
    5. Who were the people in your life who supported your use of an AFO?
  4. (observability) What were some of the benefits you could see from wearing the AFO?
    1. How did you define “success” in using the AFO?
    2. How did other people in your life talk about changes they could see from you using the AFO?
    3. Talk about any things you expected to see from using the AFO but did not actually happen.
  5. (Relative advantage) What other things have you tried to help with claudication or to help with walking? Thinking about these things you have tried before to help with claudication and walking, how does wearing the AFO compared? Have you heard of other things that could help?
    1. How was AFO easier or more difficult? How was it more or less compatible with your lifestyle? How was AFO easier or harder to test out? How was this different?
    2. Compared to other things you tried, how did the AFO intervention impact your physical activity level, your daily habits, time resources, and quality of life?

  6. (Low-cost) What changes, if any, in your out-of-pocket cost was associated with wearing the AFO? (Cost #2) How did wearing the AFO impact the amount of time to do daily tasks? For example, wearing clothes, putting AFO on and shoes and going for a walk, etc., does it take longer now or makes the task more difficult because now the AFO has to be put on?

AppendixC. The criteria for reporting qualitative research (COREQ)[23](used to validate the interview data).

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Footnotes

PARIHS implementation framework

Declarations

Ethics approval and consent to participate: The study was approved by the Institutional Review Board at the Nebraska-Western Iowa Veteran Affairs(VA) Medical Center and consent to participate was obtained.

Consent for publication: Consent for publication was obtained.

Disclosures:

We declare that some ankle-foot orthoses used in this study were donated to the University of Nebraska at Omaha by Ottobock. There are no other competing or financial interests with regard to this work.

Clinical Trial Registration No.: NCT02902211. Registered July 17th, 2017 https://clinicaltrials.gov/ct2/show/NCT02902211

Conflicts of Interest

The authors would like to declare that some ankle-foot orthoses used in this study were donated to the University of Nebraska at Omaha by Ottobock. There are no other competing or financial interests with regard to this work.

The authors report no relationships that could be construed as a conflict of interest.

Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Availability of supporting data:

Supporting data is available and uploaded as supplementary resources and files.

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