A scoping review of patient-reported outcomes for post-stroke patients with lower limb orthosis

Abstract

Gait disturbances due to hemiplegia after stroke reduce healthy life expectancy. Rehabilitation treatment guidelines in various countries recommend the use of lower limb orthoses for hemiplegia patients. Although objective outcomes such as motor function have been used to evaluate orthosis effectiveness, subjective patient-reported outcomes from orthotic users are increasingly being studied. Although patient-reported outcomes directly reflect patient health status, and tools have recently been developed to measure orthotic satisfaction, evidence on orthotic effectiveness remains limited. We conducted a scoping review to clarify the usefulness of patient-reported outcomes in evaluating the effectiveness of lower limb orthotic therapy for post-stroke hemiplegia patients. The review showed that patient-reported outcome evaluation studies on lower limb orthoses after stroke are mainly conducted in Europe, the USA, and Asia. Randomized controlled trials are frequently conducted in the USA and Europe, whereas observational studies are more common in Asia. The Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 is the most frequently used patient-reported outcome measure and was found to be useful for both primary and secondary outcomes. However, owing to the limited number of studies, comprehensive evidence on the usefulness of patient-reported outcome evaluations remains lacking. Future research should focus on the international standardization and multilingual adaptation of such evaluations.

Introduction

Hemiplegia following stroke causes gait disturbances, which are a common reason for requiring care [1]. Limited mobility, being bedridden, and frailty can also lead to dementia, and reduce quality of life (QOL) and healthy life expectancy [2]. Rehabilitation treatment guidelines for post-stroke care in various countries recommend the use of lower limb orthoses for hemiplegic patients [3-7]. The 2021 Japanese Stroke Treatment Guidelines state that “it is reasonable to use short ankle foot orthoses (AFO) to improve walking function in patients with equinovarus foot after stroke.” [8]

Since the 1990s, patient-reported outcomes (PRO) have been considered important for evaluating the effectiveness of treatments, new drugs, and medical devices. PRO evaluation refers to health status measurements directly obtained from patients, without modification or interpretation by clinicians or other people [9]. Widely used PRO measures include the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and the EuroQol 5-Dimensions 5-Level (EQ-5D-5L) questionnaire [10].

In the field of orthoses, the 2007 International Society for Prosthetics and Orthotics consensus conference stated that “User involvement including satisfaction surveys must be an integral part of outcome assessment” [11]. In Japan, the need for follow-up and PRO evaluation for lower limb orthosis users after stroke is increasing [12]; however, current evaluations of orthotic therapy effectiveness for stroke primarily focus on functional outcomes related to the user’s motor abilities. No studies have investigated the effects of lower limb orthoses on QOL, adverse events, fall frequency, and activities of daily life [13]. In 2022, Kobayashi et al. noted that because of the lack of information on PRO in orthotic therapy after stroke, evidence demonstrating the effectiveness of orthoses is limited [14]. Several tools for measuring orthotic satisfaction, such as the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0) and the Orthotics and Prosthetic Users’ Survey (OPUS), have been developed [15]. However, the limited number of relevant studies makes it difficult to conduct meta-analyses of results from multiple randomized controlled trials (RCTs) [12].

Therefore, we conducted a scoping review to clarify how PRO evaluations are conducted and whether they are useful indicators for evaluating the effectiveness of lower limb orthotic therapy for post-stroke hemiplegia patients. A scoping review is a comprehensive investigation of the literature to clarify what research has been conducted in a specific field, identify important concepts and definitions, and ascertain related characteristics and factors. And in this review, we will focus primarily on “health-related quality of life with orthotic users” and “satisfaction with orthoses and related services” as PRO evaluation measures for orthotic users. We aimed to clarify the status of research in this field to determine whether PRO evaluations, which reflect the subjective views of orthosis users, can serve as indicators of the effectiveness of orthotic therapy in stroke rehabilitation, and we discuss their necessity and feasibility.

Materials and Methods

Study Design

This was a scoping review of previous research on PRO of orthosis users with hemiplegia after stroke. The review was conducted following the framework of the Joanna Briggs Institute [16]. To address the research question, we targeted adult patients with hemiplegia after stroke (P: Patient), focusing on the concept of PRO evaluation related to the use of lower limb orthoses (C: Concept), and searched for literature in both domestic (Japan) and international contexts (C: Context) to investigate the status of relevant research and identify evidence based on the results.

Data Search and Selection

For the literature search, we used PubMed for English-language articles and Ichushi-Web (Japan Medical Abstracts Society) for Japanese-language articles to clarify the research status in Japan during the same period. In searching for articles in each language, the database was selected for its comprehensiveness, searchability, and reliability. The search period was from January 2000 to November 2023. We searched for articles that included the terms “stroke” and its synonyms in the title and abstract, the term “orthosis” and its synonyms in the title, and “PRO,” “satisfaction,” or “health-related QOL (HRQOL)” in the title and abstract. Eligible article types were abstracts, peer-reviewed articles, and conference proceedings.

The PubMed search formula was as follows: (“cerebrovascular disorder”[Tiab] OR “stroke”[Tiab] OR “brain infarction”[Tiab] OR “lacunar”[Tiab] OR “brain injury”[Tiab]) AND (“orthosis”[Ti] OR “orthoses”[Ti] OR “orthotics”[Ti] OR “orthotic”[Ti] OR “orthotic device”[Ti] OR “brace”[Ti] OR “splint”[Ti]) AND (“PRO”[Tiab] OR “patient reported outcomes”[Tiab] OR “patient reported outcome”[Tiab] OR “satisfaction”[Tiab] OR “QOL”[Tiab]). The inclusion of “QOL” rather than “HR-QOL” as a search term in PubMed is intended to broaden the scope and find more relevant articles to enhance searchability.

The Ichushi-Web search formula was as follows: ((((((脳卒中/TA or 脳血管障害/TA or 片麻痺/TA) and 装具/TA and (満足度/TA or 健康関連QOL/TA or HR-QOL/TA or 患者報告アウトカム/TA))) and (DT=2000:2023)))).

Inclusion/Exclusion Criteria

The inclusion criteria were PRO evaluations of orthosis users with hemiplegia due to stroke. The exclusion criteria were studies related to upper limb orthoses or shoe-type orthoses, and studies that did not conduct PRO evaluations of orthoses.

Two independent reviewers screened the abstracts and titles according to the inclusion and exclusion criteria. The search results were checked for duplicate records and managed accordingly. Articles that met the inclusion criteria were included in a subsequent full-text review. Systematic reviews, studies validating measurement scales, and case reports were excluded during the full-text review.

Data Extraction (Charting)

Data relevant to the research question were extracted. Data extraction was also performed simultaneously by two independent reviewers. The extracted data comprised the study region, language, design, method overview, and types and formats of PRO used. For the studies included in the review, the following items were recorded in an Excel template: Author, year, country, reference / Sample size, mean age, stage of stroke recovery / Study methods and setting / Aims / Outcomes / Assessments / Description of PRO tools (types of evaluation indicators) / How PRO were used (primary or secondary outcomes) / Principal findings / Comments (effect of conducting PRO evaluations). Additionally, the stage of stroke recovery, the main study findings, and the study conclusions were summarized.

Analysis

Each selected article was examined and analyzed to identify the relevant information, such as author names and publication years. Particular attention was paid to items that might demonstrate the implementation methods and characteristics of PRO research (e.g., the study design, participants, and indicators used).

Results

A total of 38 articles were identified in the search, and no duplicates were found (Figure 1: PRISMA diagram flowchart). Titles and abstracts were screened according to the inclusion criteria, and 19 studies were excluded because they evaluated upper limb orthoses or shoe orthoses, or did not evaluate PRO related to orthosis use. Therefore, 19 articles proceeded to full-text review; 4 of which were excluded because they were scale validation studies (n=1), systematic reviews (n=1), or single case reports (n=2). After the full-text screening, 15 articles were retained.

Study Summary

All reviewed articles were published after 2010. The final analysis included 15 articles, of which 12 were in English [17-28] and 3 were in Japanese [29-31] (Table 1). By region, there were 4 articles from Europe, 3 from the USA, and 8 from Asia. Regarding the research methods used in the studies, there were 5 intervention studies and 10 observational studies. Of the intervention studies, 3 were RCTs (all with over 100 participants) and 2 were crossover studies. Of the observational studies, 7 were cross-sectional studies and 3 were longitudinal studies. In terms of article type, there were 14 original articles and 1 conference proceeding.

Participants and Comparators

One study involved participants in the recovery phase, and fourteen studies involved participants in the chronic phase. Five articles included “cognitive impairment” in the inclusion/exclusion criteria, and three articles included “mental disorder.” Although the studies used terms such as “severe” and “affecting the ability to provide consent or follow instructions,” none established specific evaluation criteria for these conditions. Comparators included 5 studies that compared functional electrical stimulation with conventional orthoses, 5 studies that compared orthoses with different manufacturing processes, materials, or functions, and 2 studies that compared user groups based on usage conditions or gender. There were also 3 descriptive studies without comparators.

Study Objectives and Outcomes

Ten of the reviewed studies aimed to confirm the effectiveness of orthoses, and five studies evaluated the usage conditions, orthoses themselves, and the effect of PRO. All the studies that confirmed orthosis effectiveness combined PRO evaluation indicators with physical function indicators such as walking and balance. Of these, 8 out of 10 studies used PRO indicators as secondary outcomes, and only 2 used them as primary outcomes. In studies that evaluated the effect of PRO, all used PRO indicators as primary outcomes. One of the studies that used a primary outcome was an RCT designed to compare custom-made orthotics to off-the-shelf orthotics.

QUEST 2.0 Evaluation

Table 2 summarizes the characteristics of the four studies that used the QUEST 2.0. One of these studies was in Japanese and three were in English. Three were observational studies, and one was an intervention study. All three observational studies were cross-sectional. Studies using the QUEST 2.0 as the primary outcome aimed to investigate the effect of orthosis satisfaction on physical function and the relationship with orthosis fit. Ishiguro et al. (2017) conducted an observational study with 35 chronic stroke patients to clarify the relationship between orthosis satisfaction, psychological effects, and orthosis use at home, using physical function indicators, the QUEST 2.0, and the PIADS [30]. Although there was no significant difference in QUEST 2.0 results between the home orthosis use group and the non-use group, the authors suggested that psychological factors, in addition to some physical functions, are involved in the use of orthoses at home. In a 2018 study by Swinnen et al., 49 patients with central nervous system motor disorders (including 26 stroke patients) were surveyed using the MIRAD-ACCORT-II (reasons for use) and the Dutch version of the QUEST 2.0 (satisfaction with use) to analyze differences in responses between men and women [23]. Both genders reported that aspects related to comfort and functionality were far more important than aesthetic aspects, and they were generally very satisfied with the orthotic devices and the provision process. The findings from both of these studies suggest that PRO evaluation results are related to orthosis use.

Two of the reviewed studies used the QUEST 2.0 as a secondary outcome, combining it with physical function evaluations to compare the effects of orthoses constructed with different manufacturing methods and materials. A 2022 study by Fu et al. focused on the effects of 3D-printed lower limb orthoses used by 10 patients with initial hemiplegic stroke [25]. They compared three conditions (3D-printed ankle foot orthoses, forefoot orthoses, and barefoot) using plantar parameters and QUEST 2.0 questionnaires. The satisfaction survey indicated that walking with 3D-printed foot orthoses surpassed forefoot orthoses in terms of comfort and durability. Thitithunwarat et al. (2023) compared improvements in walking and balance between the use of elastic band orthoses and ankle foot orthosis in 17 stroke survivors [28]. They also compared changes in walking and balance with barefoot controls. Participants were very satisfied with elastic band orthoses, with QUEST 2.0 scores exceeding 4 out of 5 points. The findings of both of these studies suggest that the evaluation results are a valid basis for orthosis selection.

Discussion

In this study, we conducted a scoping review of previous research on PRO evaluation of orthosis use in hemiplegia after stroke. In 2018, Tricco et al. published the reporting guidelines for scoping reviews (PRISMA-ScR: Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) [32], and in 2020, Tomori et al. created the Japanese version of the PRISMA-ScR [33]. Scoping reviews serve as a preliminary step before conducting systematic reviews, and help to identify and analyze knowledge gaps. The present study identified only 15 relevant articles, only 3 of which were RCTs. Therefore, we concluded that there is insufficient research to conduct a systematic review at this point, and that a scoping review was more appropriate.

This scoping review examined how PRO evaluations are conducted and whether they are useful indicators in determining the effectiveness of lower limb orthosis therapy for hemiplegic patients after stroke. PRO evaluations are recommended as outcomes for post-stroke patients [34], and health-related QOL is considered an important outcome in stroke research [35]. Additionally, patient satisfaction is related to the quality of treatment [36], and poor orthosis compliance is associated with poor QOL [37]. The findings of this review of previous research could contribute to the design of research studies to implement PRO evaluations.

Overview of the Studies

The PRO evaluation studies of stroke patients were conducted in approximately the same geographic areas in which other PRO studies on orthotics have been conducted. RCTs with over 100 participants are feasible in the USA and the UK, and intervention studies on orthosis therapy, as well as observational studies, have been conducted in these countries. Many observational studies have also been conducted in Asia, indicating a widespread research interest in this field. However, much research in this area from Japan has not been published in English, and so its international impact may be low.

Participants and Comparators

Most of the reviewed studies targeted patients in the chronic phase, and it is often these patients for whom the concept of PRO is most relevant [12]. As PRO evaluations directly measure patients’ experiences, it is necessary to establish criteria for cognitive function to ensure that post-stroke patients understand the questions [9]. The International Society for Quality of Life Research guidelines [38] state that PRO should be used only with patients capable of self-reporting, but the criteria for determining such capability are not clearly defined. About half of the studies analyzed did not include definitions of cognitive impairment in the inclusion/exclusion criteria, so this is an issue that requires further clarification in future PRO evaluations.

It was found that PRO indicators are used to compare the effectiveness of orthoses with other treatments and to compare the effectiveness of different orthoses. This is similar to the comparators in previous systematic reviews [39] on the effectiveness of prosthetics and orthotics. As new orthotics are developed and technology evolves, the role of PRO evaluation is likely to increase. Additionally, the present findings suggest a need for PRO evaluations of factors that substantially affect orthosis use, such as differences in usage environments and gender.

Study Objectives and Outcomes

We found that there were two main ways in which PRO evaluations were used to investigate the effectiveness of orthosis treatment for stroke patients. One method is to use PRO evaluations as supplementary indicators of physical function evaluation (i.e., as secondary outcomes to show the relationship with other indicators). The other method is to use PRO indicators as primary outcomes to show how they affect orthosis use. These methods correspond to the types of endpoints recommended in PRO guidelines in the USA [9]. Many studies outside Japan have used PRO evaluations to determine the effect on physical function improvement as indicators of orthosis effectiveness. In Japan, however, PRO indicators have been used only as primary outcomes, and their relationship with other indicators has not been investigated. This may indicate the importance of PRO research for understanding post-stroke hemiplegia and orthotic treatment in Japan; however, future studies should aim to comprehensively confirm results using multiple indices to increase reliability.

Of the articles reviewed, 60% used an original questionnaire that was not evaluated for scale characteristics such as reliability and validity. The use of single questions should be avoided because they provide insufficient information for appropriate analysis of PROs [40]. Additionally, most of the questionnaires used were one-shot assessments, preventing comparisons with the findings of other studies. The QUEST 2.0 is the only measure that was used by several (i.e., 4) of the 15 reviewed studies. A systematic review of PRO studies on orthotics [41] described the QUEST 2.0 as being well validated to assess patient satisfaction with orthotics, and the high reliability and validity of this scale has been established. It was used as both a primary and secondary outcome in the studies reviewed here. To improve the evidence on the subjective experiences of stroke patients using orthoses, more studies are needed that use a consistent index like the QUEST 2.0 to enable comparison and confirmation of findings.

QUEST 2.0 Evaluation

The QUEST 2.0 evaluates user satisfaction with assistive devices, including prosthetics and orthotics, and is also used for wheelchair satisfaction evaluation. It is highly versatile owing to its simplicity (it contains only 12 questions) and the fact that it has been translated into multiple languages. A systematic review of studies on orthosis satisfaction evaluation concluded that the QUEST 2.0 is a well-validated indicator. The Japanese version of the QUEST 2.0 was developed in 2004, and its reliability and validity have been confirmed in Japan. However, few studies worldwide have used the QUEST 2.0 for PRO evaluation in lower limb orthosis users after stroke [12].

The QUEST 2.0 can be used as both a primary and secondary outcome. Studies that have used it as a primary outcome have aimed to clarify the relationship between orthosis use and factors such as reasons for acceptance and gender differences in satisfaction, to obtain evidence about which orthoses are effective and most acceptable to users. Studies that have used this measure as a secondary outcome have combined it with other physical function evaluations to provide supplementary data for comparing different treatment methods or orthoses with different designs and materials. Such studies provide useful evidence that could inform orthosis selection and improve user understanding.

However, these previous studies have not examined whether PRO evaluations are as useful as physical function evaluations for measuring orthosis effectiveness. Although subjective evaluations by patients are important, they are not sufficient on their own. Without the use of physical evaluations of orthosis use, it is impossible to determine whether physical function has improved sufficiently that the orthoses are no longer needed, or if there are issues with the orthoses themselves. Future studies that clarify the correlation between PRO and physical function may generate stronger evidence about the effectiveness of lower limb orthoses for stroke hemiplegia patients.

Study Limitations

Only 15 articles were reviewed in this study, making it difficult to conclude that the findings are sufficient to understand the current status of PRO research in this area. In addition, as articles in languages other than English and Japanese were not included, the findings may not provide an accurate picture of the global research environment.

Conclusion

This scoping review aimed to clarify whether PRO are useful indicators in determining the effectiveness of lower limb orthosis therapy for hemiplegic patients after stroke. Currently, studies are needed to evaluate orthoses using PRO, indicating that PRO play a supplementary role in physical function evaluation and a primary role in demonstrating the effect of PRO evaluation on orthosis use. Although there are limited findings on PRO evaluation as an effectiveness indicator for orthoses, a commonly used indicator seems to be the QUEST 2.0. Future studies need to improve study design, standardize the indexes used, and establish inclusion criteria for PRO ratings of orthotics in post-stroke hemiplegia to clarify the relationship between PRO and physical function assessment.

Acknowledgments

I (N. Tanikawa) would like to express my sincere gratitude to Professor Kenji Suzuki of the Graduate School of Health and Welfare, Niigata University of Health and Welfare, for his extensive guidance as my academic advisor throughout this study. I also thank Ms. Huyen Tran Thi Thanh of Tokyo Human Health Sciences University Vietnam, Vietnam, for her useful advice in the preparation of this paper. We thank Diane Williams, PhD, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript.

Compliance with Ethical Standards

There are no conflicts of interest to disclose regarding this study.

Abbreviations

EQ-5D-5L: EuroQol 5-Dimensions 5-Level

OPUS: Orthotics and Prosthetic Users’ Survey

PIADS: Psychosocial Impact of Assistive Devices Scale

PRISMA-ScR: Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews

PRO: Patient-reported outcomes

QOL: Quality of life

QUEST 2.0: Quebec User Evaluation of Satisfaction with Assistive Technology 2.0

RCTs: Randomized controlled trials

SF-36: Medical Outcomes Study Short-Form 36-Item Health Survey

SIS: Stroke Impact Scale

SSQoL: Stroke Specific Quality of Life (SSQoL) Scale

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