Observation of the rate of skin breakdown and pain secondary to prefabricated ankle foot orthosis usage during gait training in an inpatient stroke rehabilitation unit

Introduction Patients who are affected by debilitating strokes and subsequently admitted to acute inpatient rehabilitation units present with a wide variety of pathology based on the location of their respective strokes. Pathology may range from difficulty with coordination, muscle stiffness, impaired motor planning, and more. Regardless of presentation, impaired gait function after stroke strongly contributes to overall patient disability and increases the risk of falls.1 The primary goal for inpatient rehabilitation is to improve gait stability and efficiency. Weakness in ankle dorsiflexors is commonly observed in the acute stage of stroke. This can hinder gait training due to foot drag in the swing phase.2 In clinical practice, custom-fitting ankle foot orthoses (AFOs) are commonly recommended for improving the long-term safety and efficiency of a patient’s gait pattern, especially in patients with ankle dorsiflexion weakness.3,4 However, due to insurance regulations and the extended time needed for obtaining custom AFOs, prefabricated AFOs are typically standard of care instead during acute inpatient rehabilitation stays. Therapists attempt to use the best-fitting prefabricated AFOs (of what is available at a particular facility) to support patients with ankle weakness and instability to facilitate gait training. Although this is common practice, unforeseen complications may arise from the use of prefabricated AFOs, such as increased pain and discomfort, skin changes including abrasions and pressure ulcers due to improper fit or function of the brace and inefficiency of the overall gait training due to the time needed to make necessary modifications to the brace. During the acute inpatient rehabilitation stay, patients undergo at least 3 hours of intensive therapy per day for five days per week on average for the duration of one to several weeks. A recent retrospective survey was conducted in the inpatient stroke rehabilitation unit of one of the author’s institutions. The responses from the 8 inpatient physical therapists indicated that >50% of prefabricated AFOs did not fit well, and a significant number of patients experienced skin breakdown associated with AFOs as well as dissatisfaction (data not included). However, there are few studies that evaluate the use of prefabricated AFOs and associated potential complications during intensive rehabilitation.5 The primary objective of this study is to examine the relationship between hospital-acquired injuries and the use of prefabricated AFOs during gait training in acute inpatient rehabilitation. This study reports the prevalence of these injuries and associated complications as well as the burden on therapists to modify these prefabricated AFOs. Methods This was a prospective study analyzing patients with stroke who needed a lower extremity orthotic device for gait training while in an acute inpatient stroke rehabilitation unit. The study and consent were approved by the author’s (MT) Institutional Review Board (IRB). This study conforms to all Strengthening the Reporting of Observation Studies in Epidemiology guidelines and reports the required information accordingly (Supplementary Checklist, http://strobe-statement.org). Potential subjects were screened during admission, interdisciplinary team rounds, and gait rounds by physical therapists and physiatrists within the first 5 days of admission to the acute stroke rehabilitation unit. The treatment team would assess the feasibility of orthotic usage and determination of benefit from an AFO. Prefabricated AFOs are standard of care for patients receiving gait training during the inpatient rehabilitation stay. After patients met eligibility criteria, consent was obtained from those willing to participate in prefabricated AFO-associated pain and skin complication assessment. Subjects were enrolled in the study sequentially—as they fit the study criteria and agreed to participate. A second phase of the study that evaluates the custom 3D-printed orthotics is underway following the same sampling approach. Inclusion criteria: patients with a stroke diagnosis, residual ankle dorsiflexor weakness, and who were likely to benefit from AFO use during the inpatient stay; exclusion criteria: patients younger than 18 years old, pregnant, nonambulatory before admission, or unable to consent. Primary outcomes Orthotic-related limb pain, pressure-related skin complications, and general pain were the primary outcomes. All subjects received individualized therapy sessions and were assessed daily (pretherapy and post-therapy) for limb pain, skin breakdown, and other adverse events related to the AFO. The orthotic limb-specific pain scores were graded using an 11-point visual analog scale (VAS, 0-10). Skin complication was assessed and staged based on the national pressure ulcer staging system.5 The pain score and skin complications were documented in the electronic medical records as standard of inpatient rehabilitation care. The data were retrospectively reviewed, and analysis was performed to focus on the change between pretherapy and post-therapy sessions. Secondary outcome Physical therapists reported the efficiency of orthotic application (modifications made to AFOs) as a secondary outcome. A therapist assessment (Table 1) was completed by therapists for each patient. Table 1 - Pretherapy and post-therapy assessment Pretherapy Generalized pain level (VAS 0-10) Orthosis-specific limb pain level (VAS 0-10) Orthosis-specific limb skin abnormalities (location, description, and size) Post-therapy Generalized pain level (VAS 0-10) Orthosis-specific limb pain level (VAS 0-10) Orthosis-specific limb skin abnormalities (location, description, and size) Number of modifications made to the prefabricated AFOs since the beginning of the session (please comment on the type of modifications including taping, wrapping, type of AFO, and change of AFO) Statistical analysis Descriptive statistics were used for all outcomes (means for number of brace modifications, skin issues, VAS pain scores and times to occurrences of these; %s for appropriate data such as fractions of patients experiencing pain or skin issues). Qualitative observations were recorded regarding the type of skin breakdown, location of pain, and type of modification to brace performed. The Wilcoxon Signed-rank (WSR) test was used to determine the statistical significance of changes in the score for comparing predata and postdata for pain and skin issues. The paired data option was used for WSR calculations. A two-tailed P-value was reported to compare to a significance threshold of 0.05. Results Thirty patients were enrolled; data from 26 subjects were analyzed; four subjects did not complete their inpatient rehabilitation program due to medical complications. The average age was 57.5 years (Table 2). On average, subjects spent 16 days and 10.8 sessions in gait training as part of their inpatient care. Eleven (41%) received a custom AFO upon discharge from inpatient rehabilitation after 16.5 days from admission, on average. The main results are shown in Table 3, with key calculations for the statistical results (Wilcoxon Signed Rank test) shown in Table 4 for the only significant result (limb pain). Two of the subjects’ skin breakdowns developed into non-blanchable, stage I pressure injuries. No stage 2, 3, or 4 pressure injuries were developed in our study group. On average, onset to pain was 8.1 days for the 58% of subjects who developed orthosis-related limb pain. Skin complications occurred after 9.5 days after orthoses were initially used during gait training, for the 50% of subjects who developed these issues (Table 3). The skin complications were most found at the base of the fifth metatarsal followed by malleoli. For 18 patients (73%), the therapists needed to provide, on average, 2.8 (0.9 pre Tx + 1.9 post Tx, data not shown) modifications per patient, including padding, wrapping, and more. Table 2 - Patients’ demographic information (N=26) Demographic information Females 12 Males 14 Average age (y) 57.5 Table 3 - Key study results Variable Chg. Score (post-pre) P (Wilcoxon signed rank) Frequency of occurrence (% total subjects) Time to onset (d) Skin issues +0.7 0.455 50 9.5 General pain +0.7 0.096 62 8.1 Limb pain +0.9 0.005 58 8.1 AFO mods +1.0 NA 73 NA Note. For Change scores, Wilcoxon analyses and Frequency of occurrence, subjects who had both pre- and post-Tx scores of zero were not included in the calculation. Thus, if either score was non-zero, that value was included in the analysis. This means if they had a non-zero score but it did not change, it was included in the this analysis. Table 4 - Wilcoxon signed-rank test computations for limb pain Pre Post Median 0.0 0.3 Count 26 — No. unequal 14 — T+ 10 — T− 95 — T 10 — Two tail Mean 52.5 SD 15.930 z-score 2.668 Effect r p-norm 0.00763041 p-exact 0.00524902 p-simul 0.0051 Calculations were performed using real statistics, https://real-statistics.com Prefabricated AFOs are widely used in gait training for patients suffering from strokes during acute inpatient rehabilitation. These prefab AFOs are the current standard of care, with few options otherwise. Poorly fitting prefabricated AFOs may result in adverse pain and skin integrity issues and therefore diminish effective gait training and may cause hospital-acquired injuries.6 Our study has demonstrated the prevalence of these problems and associated low satisfaction from the therapy team. We are unaware of similar data being previously published. Using a prefabricated AFO during acute inpatient rehab is associated with relative increases in skin breakdown and limb pain and requires multiple modifications throughout a patient’s rehab stay. Based on these findings, improvements in the quality and tolerance of AFO bracing during the early phases of acute inpatient rehabilitation would seem both possible and welcome. Three-dimensional (3D) printing is a relatively recent technological advancement that allows for accurate fabrication of any desired object given a suitable digital representation; this has not been utilized to its full potential in the clinical setting.7,8 With regard to orthosis production, studies have shown similar performance and gait benefits between traditionally made and 3D-printed custom-fit orthoses. 3D printing, however, also provides ultimate customization that has been shown to reduce discomfort, increase overall fit, and allow for easier prototyping in a more efficient manner.9,10 No current studies have examined the role of 3D printing for temporary orthosis production in the acute inpatient rehabilitation setting. Compared with the current standard of care with prefabricated AFOs, we speculate that 3D-printed AFOs will reduce hospital-acquired injuries, such as pain and skin changes, in addition to increasing efficiency and therefore time that a therapist can spend face-to-face with the patient. We are currently mid-way through data collection in the next phase of the study that does this. Study limitations Our study has several limitations. We did not monitor or adjust for details surrounding pain medications, including usage frequency, dosing, or timing, which could change how patients perceive their pain. In addition, other variables, such as type of stroke and presence of spasticity or contractures, were not accounted for. Third, this is a pilot study, and the numbers represented are not generalizable to the broader stroke rehabilitation population. Lastly, there are no data assessed for long-term usage of prefabricated AFO. It would be noteworthy to see whether patients in this study who later received custom-molded AFOs had a relative decrease in their pain, skin breakdown, and required modifications. However, data collection ceased upon patients who received the custom-molded AFO. Further research and evidence are necessary in this area of rehabilitation to improve patient comfort, safety, and overall outcomes in their journey of recovery (Fig. 1).Figure 1: Box and whisker plot for time to pain and time to skin issues.CRediT author statement Mukul Talaty: Data Curation, Formal Analysis, Funding Acquisition (secondary), Methodology (related to 3DP aspects), Project Administration, Resources, Supervision, Validation, Writing - original draft, Writing - reviewing and editing. Brendan Mullen: Data Curation, Formal Analysis, Investigation (Data collection), Project Administration, VIsualization, Writing - original draft, Writing - reviewing and editing. Ryan Hafner: Conceptualization, Data Curation, Funding Acquisition, Investigation (Data collection), Methodology, Project Administration, Writing - original draft, Writing - reviewing and editing. Ning Cao: Conceptualization, Funding Acquisition, Methodology, Project Administration, Supervision, Writing - original draft, Writing - reviewing and editing. Declaration of competing interest There is no competing Interests or financial benefits to the authors. Funding Funding and support for the conduct of this research study are provided by the Albert Einstein Society, a nonprofit group focused on the advancement of research in the Albert Einstein Healthcare Network. The data sets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request. Ethics statement All subjects provided informed consent and the study was approved by the IRB of Albert Einstein Medical Center. Data availability statement The data sets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request. Acknowledgments The team of Physical Therapist at the Elkins Park campus of Jefferson-Moss-Magee were instrumental in obtaining these critical data. Sarah McGuckin helped in performing and verifying some of the initial data analysis. Declaration of generative AI and AI-assisted technologies in the writing process No AI tools or services were used for the writing of any sections of this paper.