This study used qualitative methods to address the questions by organizing focus groups at 4 SCI model systems (SCIMS): (1) Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago), (2) Craig Hospital, (3) Shepherd Center, and (4) TIRR Memorial Hermann. These centers chose to participate in the AbilityLab's collaborative module during the current SCIMS funding cycle. The focus groups occurred between February and April 2017, comprising primarily physical therapists with experience using robotic exoskeletons. Clinicians provided informed consent and received a modest honorarium.
Collaborators developed a discussion guide, which the moderator used for all focus groups (see the Appendix). The moderator led the AbilityLab focus group in person and used videoconferencing technology to lead focus groups at the other 3 centers. A court reporter took verbatim notes and provided a transcript of the discussion. Research staff members took notes to supplement transcript reviews, which provided the basis for qualitative coding and analysis.
We adopted a thematic coding approach18 to summarize clinicians' responses to questions regarding patients' motivations for exoskeleton use and their perceived risks and benefits of exoskeleton use; most questions did not require qualitative coding as they focused on details regarding settings in which exoskeletons are used, eligibility criteria, assessment protocols, and other therapy procedures. For questions requiring qualitative coding, the procedures involved developing a codebook, testing the reliability of codes, summarizing data and identifying initial themes, applying code templates, connecting codes and themes, and corroborating and legitimating coded themes. Center principal investigators and coordinators participated in codebook development and transcript coding. They resolved coding discrepancies by discussing their different perspectives and reaching code consensus. Northwestern University's and Shepherd Center's institutional review boards approved the protocol.
Table 3 summarizes the characteristics of the 30 focus group participants. The sample represents nearly all therapists trained in exoskeleton use, although a few did not participate because of illness or schedule conflicts. They were predominantly female and white and had an average of 10 years of clinical experience. Most were physical therapists but included other clinical and support staff members with training and experience in the use of robotic exoskeletons.
Focus Group Data
We organize focus group data under 3 topics: (1) exoskeleton experience, clinical evaluations, and training strategies, (2) exoskeleton benefits and risks, and (3) exoskeleton preferences. Two investigators read the transcript from each of the 4 focus groups, highlighted text relevant to patients' motivation for seeking therapy incorporating exoskeletons and clinicians' perceptions of risks and benefits. Thematic code development was straightforward, given the finite range of responses and consistency of responses across centers. Coders achieved consensus by discussing the instances for which they initially assigned discrepant codes. Investigators did not code responses to questions focused on procedural details of therapy involving exoskeletons, given the fact-focused nature of the questions.
Topic 1: Exoskeleton Experience, Clinical Evaluations, and Training Strategies
Topic 1 included several subtopics, perceived benefits and risks of exoskeletons pertaining to therapists' experiences, clinical evaluations, and training strategies. Table 4 summarizes the therapists' answers to the discussion questions at each center. The “topic column” represents the questions posed to each of the groups. The table's cells contain bulleted lists summarizing the discussion.
Participants reported using exoskeletons for various clinical and research applications. All used exoskeletons in outpatient settings and community wellness facilities, with 1 center (TIRR) reporting selective use during inpatient rehabilitation. All SCIMS centers followed device manufacturers' patient selection criteria faithfully.
Clinicians commented on the lack of guidance available regarding the integration of exoskeletons into rehabilitation therapy services. One clinician stated:
When we were going through the training with devices we pulled some folks from inpatient, some of our other programs ... in order for us to get experience, but we are still trying to kind of figure out how, from an outpatient perspective, we are going to be utilizing the devices ... on a more regular basis in our centers. So really the main experience that ... [we had] are just folks who have ... decided to purchase a device, and ... are using their insurance benefits to come ... for training.
Another therapist elaborated on the limited evidence base:
This is a new device for us, and so we are being very systematic about what are we doing with the decision[s] we are making, so that people feel like they have support for the decisions that they may be making as an individual.... We have started in the key area of outpatient because that was a little cleaner, and we also ... had people that were ready to go and willing to get their personal devices.
Clinicians emphasized the importance of screening candidates thoroughly to avoid adverse consequences:
I think out in the community people are going to fall, and they probably will injure themselves, and whether you have 6 pounds on top of you if you are walking in of them versus 26 pounds, I think there is risks for injury, for fracture, for ... bone fractures or skin injury. But I think the key to that in reducing that is proper screening and the training that goes behind it the screening process and the education is really important to reduce those risks.
Another focus group participant emphasized discussing patients' expectations during screening, considering not only physiological and functional characteristics but also psychosocial characteristics. A clinician commented:
...screening for personal use aspect, I think what it really boils down to is us just being able to have open and honest conversation. It's not necessarily trying to discourage anybody from buying a device that they want, but ... asking them.... ‘Realistically, what are your expectations? What do you expect to be able to do in this? And then, letting them know whether or not ... A) the device is safe to use with or do in. But ... B) taking into consideration ... is there a support person. Their 65-year old mom who might be in good shape but ... cannot necessarily offer maximum assistance if this person needs a significant amount of assistance ... we have to have this conversation from the very beginning.
Participants reported that treatment goals typically focused on standing, stepping, and gait training. One center selectively provides inpatients with 6 sessions of exoskeleton training. One therapist described his or her approach:
Our current model that we are using in inpatient is they get six sessions ... patients love getting up with the device, and then they kind of don't want to do anything else ... In an inpatient's world you have a lot of other things that have to be addressed as well, so we have kind of a limited access to it.
A typical episode of outpatient exoskeleton therapy consists of 20 to 30 sessions. The minimum number of staff involved in an exoskeleton therapy session across centers was 2, although on occasion more staff were involved, depending on patients' needs.
Standardized assessments used across centers included the 10-m and 6-minute walk tests; individual centers reported using a variety of balance, exertion, and manual motor tests to assess outcomes associated with exoskeleton training.
Clinicians discussed the issues they consider when recommending various locomotor training strategies:
If I'm only able to do 10 minutes of gait training in a robot, and I can get 35 minutes in on a treadmill, I think there is a dose difference there.
Clinicians discussed strategies to integrate exoskeletons into rehabilitation therapy services and the motivational influence of exoskeletons. One clinician stated:
... that speaks volumes to motivating them to do a lot of their other functional tasks, because some of the other goals they might not want to work on, but we can kind of use it as like a “carrot” and be like: “All right, if you do this transfer, and work on this transfer this day, then by the end of the week we will be able to try to get you up on the robot”.... I think that has a big ... influence on a lot of other stuff we try to do.
Topic 2: Exoskeleton Benefits and Risks
Focus group participants identified a variety of perceived physiological, psychological, and social benefits and risks associated with exoskeleton use (Table 4). In addition to improved gait while in the exoskeleton, they related patient claims of improved cardiorespiratory function, reduced pain, improved bowel and bladder function, and improved self-confidence and self-image. Therapists also identified several risks including fall-related injuries, skin irritation, and high patient expectations. One participant commented regarding patients' perceived benefits:
[Reduced] pain and spasticity seem to be the top two. We have had some folks talk about their bowel and bladder, so it changes in how quickly they feel they can manage their bowel program. I had one person talk about sensation changes in their bladder. But again, they were also getting a lot of other interventions at the same time.
Another clinician added:
We've noticed changes in sensation in bowel and bladder for sure. So ability to either sense ... a full bladder, a need to cath or to sense the bowel program.
Clinicians also perceived health and wellness benefits.
Dynamic weight bearing is beneficial for ... full health ... getting just up and out of their chairs in an upright position. It's just for the cardiorespiratory function and also placing everything on the heart because a lot of people will also end up getting that ... from ... dynamic weight bearing. And then ... one thing that definitely should not be discounted is the psychosocial benefits, just being upright and feeling what it's like to walk again.
Clinicians observed reductions in medication for spasticity and infections, saying:
We have seen people significantly reduce the amount of medications that they were taking, either it was for spasm or for example, UTI. We had a couple of people when we did our big 40-person trial that had frequent UTIs, and when they were up training with the exoskeleton, their UTI significantly went away. We followed up a month later, and their UTI is back again.
Participants identified psychosocial benefits across all focus groups as a salient aspect of working with robotic exoskeletons. For example, one clinician observed the motivating influence of exoskeleton use:
The ability that some feel that they can stand up ... and actually being told that they will never ever walk again, and hearing that news, and here they are up walking, and they are like: “Can you videotape this? Can you video it?” So, I think ... psychosocial[ly] ... this gives them that hope that ... “Someday I may be able to walk again.”
Another focus group participant observed:
If they feel like this [is] something that will make them get better, and stronger, and walk more and, ..., in a better pattern, then they will give it a try and they will be willing to see what it has to offer for them.
Several therapists identified the psychosocial benefit of being upright and facing others eye-to-eye as a reported benefit:
Feeling more engaged in social situations rather than ... being in a chair looking up and you can't really hear what people are saying in a crowded room. That some of those psychological changes of ... being able to look at people eye-to-eye. I know we hear that a lot, but it really is extremely important to our folks that are used to being at chair level.
A common comment people say, “It's just nice to look someone in the eyes, and not be looking up at the world.”
Participants also described the critical role of patients' expectations, the risks of disappointment, and how expectations change over time.
... The other thing that I think is really critical are patient expectations. I think in this room we are all 100 percent, it's about the patient, but we also have to be open and honest with them about how they can really use these systems, and unless they come and try it, they won't know. We had a guy that wanted to purchase one of the systems, and his goal was to get up and ... use it all day at work ... drive with it in his car and all of that, and this was somebody that was part of our research program previously. And I don't know if he forgot or what, but it was about almost a year between the end of research and when this individual chose to buy one of the systems, and then when he came to try the system it was like: “Oh, well, I don't think I would use this every day.” ... They have this fantasy it's going to get rid of their wheelchair or whatever, and that's just not the case, and that's another important aspect of giving patients a choice.
Participants noted the challenges patients encountered in seeking services to use an exoskeleton:
From a funding standpoint, it's very challenging for anybody to get funding to purchase one, and then to ... find places where therapists are trained on how to use them, but then also be able to access them even if they don't have that funding.
Another therapist noted the potential burden on volunteer caregivers using an exoskeleton:
One thing to also keep in mind is how taxing is it for the caregiver or the therapist to provide the assistance and the training.
This comment contrasts with sources that anticipate reduced physical burden on caregivers and therapists during training.19
Topic 3: Exoskeleton Preferences
Focus group participants identified several enhancements they would like to see in exoskeletons (Table 4). Some patients also anticipate technology improvement, as one therapist noted:
He was still hesitant to purchase the [device] at this time. He was more interested in seeing what future technology [may bring] ... maybe something a little bit less cumbersome, looking for something more streamlined. So he wants his other equipment. I think he is just waiting for future technology.
Clinicians at each SCIMS center revealed similar practice patterns in terms of how they integrate robotic exoskeletons into physical therapy services. All SCIMS centers adhere to manufacturers' and Food and Drug Administration's (FDA's) guidance on device use but deploy exoskeletons in different settings and adopt different clinical evaluations. This variability likely reflects both institutional culture and the minimal evidence from randomized controlled trials and clinical studies to guide implementation and standardize practice guidelines.5 Clinicians who deliver robotic exoskeleton therapy mostly include physical therapists with specialist certification achieved through manufacturers' training. Many centers employ exercise specialists in addition to physical and occupational therapists. ReWalk certifies individuals without a clinical background. While clinician training and costs were not a focus of the focus group discussion guide, the costs associated with the delivery of robotic exoskeleton therapy reflect clinicians' education and training, and therefore costs vary according to the qualifications of the personnel who provide the training. Clinicians recognized the marketing value of offering exoskeletons, noting that some patients sought out the collaborating facilities for physical therapy services because they offered use of robotic exoskeletons. Therapists recognize that some patients who express interest in exoskeletons may not meet the criteria for use of these devices. As with any intervention, therapists offer education and guidance about approaches that are most appropriate to the patients' functional status, goals, and prognosis for achieving those goals.
Clinicians identified a variety of secondary benefits from exoskeleton use. They observed psychological and social benefits including satisfaction from making eye contact while standing to improved bladder and bowel sensation and function, which allows greater ease in social activities. According to the clinicians, patients do not voice secondary benefits as reasons for pursuing exoskeleton therapy, but many were pleased with these benefits.
Clinicians observed that robotic exoskeleton technology continues to evolve rapidly, limiting their adoption of devices to avoid early obsolescence. Although currently there are only 4 devices that are FDA approved, the software and hardware of these devices have changed numerous times in the last decade, making standard evaluations, fitting, and training difficult. To complicate issues further, the FDA will likely approve a dozen new devices in the coming years. Thus, larger institutions are creating exoskeleton teams with therapists with training, certification, and up-to-date information on the evolving rehabilitation robotics market.
Participants reported that patients voiced awareness of the pace of technological development as a consideration in device purchases. For example, Shepherd Center's use of exoskeletons is evolving quickly as its staff considers optimal and cost-effective ways to integrate them in therapy services. Ultimately, patient demand for robotic exoskeletons motivates facilities to investigate purchase and use of this modality. For example, TIRR Memorial Hermann provides access to exoskeleton use for inpatients so that they may try a novel technology for overground walking that they might not have access to after discharge. Patients' ability to purchase a personal mobility exoskeleton reflects a variety of considerations including individuals' resources. Locomotor training with exoskeletons also increased rapidly during the course of this study, with the AbilityLab reporting considerable growth of device use after moving to a new facility with expanded inpatient, outpatient, and home training clinics.
Several study design features limit the generalizability of the findings. Results reflect the experience of only 4 centers, all of which are part of the SCIMS; they may not be representative of all hospitals providing SCI rehabilitation nationally. Clinicians had the opportunity to decline study participation, though nearly all clinicians involved in robotic exoskeleton service delivery participated. Despite efforts to create a nonevaluative climate, the group format may have limited their willingness to voice opinions that conflicted with leadership and peer perspectives.
This study focused on therapists' perspectives due to their unique understanding and skill with exoskeleton use and physical functioning. Future studies should seek patients' perspectives in device selection and evaluation. We need a fuller understanding of the individual-, facility-, and societal-level costs and benefits associated with robotic exoskeleton use in clinical and wellness applications.
This study provides insight into the issues facilities face and the considerations clinicians use in delivering robotic exoskeleton therapy and extends our knowledge of users' perspectives.20 The 4 SCIMS centers involved in the study have similar practice patterns in terms of how they integrate overground robotic exoskeletons into physical therapy services. While they adhere to manufacturers' and FDA's guidance on device use, only 1 study center deploys exoskeletons during inpatient rehabilitation currently. Clinicians at all study centers described patients' report of bowel, bladder, and psychosocial benefits in addition to improved gait. The study centers educate patients on rapid technology development when they recommend devices to patients contemplating purchases for personal mobility. An unintended effect of these devices may be to engage patients more fully in their rehabilitation quite apart from walking or promoting neuromotor recovery by offering hope when patients struggle to see a positive future. There is currently little evidence to guide and standardize the integration of exoskeletons into rehabilitation therapy services and a pressing need to generate evidence to guide practice and to inform patients' expectations. A valuable next step would be to convene a technical expert panel to draft consensus guidelines on device use. Clinics considering use of robotic exoskeletons should define the therapy goals that are amenable to the hardware and software capabilities of specific exoskeletons; select patients who are likely to benefit from exoskeleton therapy based on institutional pilot testing, early studies, and manufacturers' guidelines; and develop strategies to ensure that patient expectations are realistic to obtain maximum benefit for therapy and personal mobility. Based on SCIMS Centers' experience, we recommend that facilities sites.
- complete training recommended by device manufacturers;
- become familiar with indications and contraindications for specific devices;
- adjust goals and protocols to individual patient's circumstances and needs;
- notify manufacturers of device malfunctions or repair needs;
- maximize patients' contributions by weaning them slowly off the motors progressively;
- monitor skin at all areas that contact the device before and after use;
- encourage users to provide feedback while using the device and adjust device settings accordingly;
- progress through a device's modes to facilitate learning and achieve specific goals;
- apply gait training strategies with application of frequency, intensity, time, and type (FITT) principle to use the device effectively and optimize patients' outcomes; and
- monitor patients' cardiovascular, integumentary, and neuromuscular responses to exoskeleton sessions.
We recommend that facilities not
- use devices with patients who have open skin lesions or wounds in the areas that contact the exoskeleton;
- use an exoskeleton device with a patient who is uncomfortable with the technology;
- assume that the device will prevent falls—continue to use usual guarding techniques;
- force the fit of the device. If a patient's fit is borderline, err on the side of caution; and
- use the same software program in an exoskeleton for all patients.
The authors appreciate the time and commitment of focus group participants and center coordinators. Supplemental Digital Content 1 includes a video that highlight this manuscript's findings.
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APPENDIX Focus Group Discussion Guide for Therapists With Robotic Exoskeleton Experience
- How do you use robotic exoskeletons in your practice?
- What criteria do you use to select patients with SCI for exoskeletons use?
- What latitude do you have in selecting patients for exoskeletons use?
- What makes/models do you use?
- Why do you use these models?
- What kinds of modifications would you like to have made to robotic exoskeletons? Why?
- How many clinicians are present when a patient is learning to use a robotic exoskeleton? If any, are they therapists? Aides? What are their qualifications?
- What does a typical exoskeleton therapy session look like? What's the breakdown of time spent on what activities. (If the answer is “it depends”—ask) It depends on what? Please give an example.
- Would you use the same number of therapists and aides for conventional therapy for the patient who uses an exoskeleton based on the answer to the previous question?
- What standardized assessments do you use to assess patients' progress using an exoskeleton?
- Do you work with patients who use exoskeletons in the community?
- What motivates patients to use exoskeletons in the community?
- What facilitates their use of exoskeletons in the community?
- What limits their use of exoskeletons in the community?
- What risks have patients experienced using exoskeletons in the community?
- What risks are you concerned about?
- What benefits do patients receive from exoskeletons use in the clinic?
- What kinds of physical benefits?
- What about social benefits?
- What about occupational benefits?
- Any emotional benefits?
- Any other benefits?
- What risks or harm have patients experienced using an exoskeleton?
- What kinds of physical harms?
- What about social harms?
- What about occupational harms?
- Any emotional harms?
- Any other harms?
- What aspects of the device, patient, or environment facilitate benefit?
- Patient characteristics?
- Device characteristics?
- Environmental characteristics?
- What aspects of the device, patient, or environment limit device benefit?
- Patient characteristics?
- Device characteristics?
- Environmental characteristics?
- Have any of your patients purchased exoskeletons?
- What kinds of patients?
- What kinds of devices?
- What kinds of activities?
- What other aspects of exoskeleton use or therapy that we have not discussed would you like to mention or add?
physical therapy modalities; qualitative research; robotic exoskeleton; spinal cord injuries
Supplemental Digital Content
© 2018 Academy of Neurologic Physical Therapy, APTA