Ten clinically stable individuals (6 men; 4 women) were recruited in an acute hospital setting (Mater Misericordiae University Hospital, Dublin) following admission with a stroke diagnosis. All ten underwent RAGT following familiarisation, eight of whom consented to the semi-structured interview and nine of whom provided data using the Likert rating scales.
Participants had a mean age of 64.5. ±12.99 years and were on average 38.9 days (range 14-79) post-stroke when recruited to the study. Eight participants had strokes of ischemic origin, one of haemorrhagic origin, and one with mixed aetiology. All were first episode strokes. One participant, who was not a native English speaker, required a translator for the interview to be conducted and the Likert scales were verbally translated. One participant had expressive aphasia and a closed question interview style was adopted to aid communication during the qualitative interview.
Eight participants (80%) had post-stroke Functional Ambulation Category (FAC) scores from 0-2 indicating they could not ambulate independently, the remainder (N=2) could mobilise without physical assistance but required close supervision due to balance problems (28). Participant demographics are summarised in table 1.
Table 1
Participant Demographics
Participant Demographics
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N = 10
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|
Mean (SD)
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Age at time of data collection (years)
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64.5 ± 12.99
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Time since stroke (days)
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35 ± 21.9
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MRS pre stroke
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0.6 ± 1.26
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MRS post stroke
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4.1 ± 0.99
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FAC pre stroke
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5 ± 0
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FAC post stroke
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1.44 ± 1.19
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N (%)
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Male Gender
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6 (60%)
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Stroke Laterality- Left
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6 (60%)
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Stroke type- Ischemic
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9 (90%)
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Qualitative Interviews
Content analysis of the interview transcriptions identified primary categories of discussion items that centred around positive aspects of the device, negative aspects, initial concerns relating to the device, the correct mindset for using the device and advice for therapists using the device in an acute rehabilitation setting. Interview data, categories and codes can be found in the appendices in table 2.
Table 2
Interview data
Categories
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Common issues reported in data (Codes)
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Frequency of codes*
|
Example of quotes
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Positive aspects of robotic gait device
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Belief device is a beneficial addition to rehabilitation
Intimidating initially but subsequently positive
Fear of falling in familiarisation phase
Feeling comfortable using the device
|
8
3
1
4
|
“Deep down I do say it will do something good.”
“It will probably help me.”
“It's quite intimidating looking… 'cause you don't think you're going to be able to move in it…And you realize that what the weight is, it's not as bad as.
“It was crazy!... I enjoyed it”
“Feelings of fall, you fall, fall on the floor, you know. In the beginning”
“I had no fear of it, even though they were talking about this that and the other, but I didn't feel any fear.”
“None of it was ever a bad experience”
|
Negative aspects of robotic gait device
|
Device fitting time
Weight of device
Degree of verbal instruction required from physiotherapists
Dis-comfort
|
2
3
1
1
|
“Too many sensors… too time to, to, yeah, to put the device on your body. And bells and stirrups and, yeah, require more shorter time”
“Just the weight... 'cause you really feel like you're- you're really are putting the effort in”
“The weight was so heavy.”
“... I think sometimes the instruction's hard to understand. Like I'm saying move to the right, move to the left, that kind of thing sometimes hard. Maybe less instruction.”
“I find it quite uncomfortable.”
|
Advice for future patients using the device
|
Have an open mind
Not to be afraid
Trust the device
Relax
|
1
3
1
2
|
“Go in with an open mind.”
“Not to be afraid of it.”
“Just go with it. Trusting. They're not going to fall over. The device will hold you up.”
“Not to be in a rush like I was… Take it easy.”
“Try and relax.”
|
Advice for future physiotherapists using the device
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Use non-clinical language
Provide less instruction
Experience using device personally
Continue as currently
|
1
1
1
3
|
“Explain in layman's terms.”
“Maybe less instruction.”
“For them to use it first…. To know what it's like. To feel how the patient will feel.”
“I don’t think there’s anything better they can do.”
“You couldn't have done anything different.”
“They're doing everything they can.”
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*Note frequency of codes indicates the number of times the code was mentioned in the transcripts.
Positive aspects of robotic gait in acute stroke rehabilitation
The majority of participants discussed their engagement with the exoskeleton gait device as a positive experience in their rehabilitation. These participants described the device as increasing their confidence and improving their gait.
“It's a good beginning” (Participant #04)
“It helps you concentrate more on your steps. It's very beneficial. It gives you confidence.” (Participant #10)
“It's just that-that it was doing the job and I was happy with it. It was doing the job right for me.” (Participant #09)
“It was crazy! Because I didn't know what I'd signed up for. But then I was glad, you know...Because I enjoyed it. None of it was ever a bad experience. Oh, I thought it was great. Couldn't believe it…. that I was walking.” (Participant #01)
The utility of the device during acute stroke rehabilitation for gait restoration was identified.
“I think it's very good because I wasn't able to move around. All I wanted to do was stay in the bed at the hospital. You know? And now I made steps with the help.” (Participant #01)
“Deep down I do say it will do something good.” (Participant #09)
There was one exception where a person who could mobilise independently but with balance deficits did not see a benefit in using the device. He commented:
“I don't think I'd need to [use to help in stroke recovery]” (Participant #08)
Negative aspects identified during exoskeleton sessions
A number of participants commented on the time to take measurements, fit and set up the device before initial use. There were approximately 30 minutes total set-up time required for each participant.
“Because you spend, many more time on preparing than going go walking.” (Participant #04)
The weight of the device was considered a negative feature by a number of participants. Some participants commented:
“(tiring) Just the weight…. 'cause you really feel like you're- you're really are putting the effort in” (Participant #10).
“The weight was so heavy. I find it quite uncomfortable.” (Participant #08)
The degree of verbal instructions provided by physiotherapists during robotic gaits was also discussed:
“... I think sometimes the instructions [are] hard to understand. Like I'm saying move to the right, move to the left, that kind of thing sometimes [was] hard. Maybe less instruction.” (Participant #08)
Initial concerns
Despite considering the experience positive in general, a number of participants identified that it was intimidating in the initial stages. Participants described worries that the device would be too heavy to mobilise in or that it might restrict their movement.
“It's quite intimidating looking. ‘Cause you don't think you're going to be able to move in it. Because it's the big steel frame around you. Yeah, but once you have started... And you realize that… what the weight is, it's not as bad as you think it…. you think it's going to restrict your movements also. But it doesn't.” (Participant #10)
[through a translator] He said that it's getting better [from first impression], he said much better. He said very well. [he liked the device?] Yes, decidedly (Participant #05)
For some, the device was associated with a fear of falling in the familiarisation phase. One participant reported:
“Good device, but very, feelings of fall, [that you might] fall, fall on the floor, you know. In the beginning.” (Participant #04)
Initial feelings of fear were not universal among all participants. One participant reported:
“I had no fear of it, even though they were talking about this that and the other, but I didn't feel any fear.” (Participant #09)
Mindset for people with stroke engaging in exoskeleton training
Participants identified that nervousness and fear could be an issue or barrier to engagement with the exoskeleton gait training device. When asked what advice they would give future stroke survivors using the device two participants stated:
“Don't be as nervous as myself.” (Participant #02)
“Not to be afraid of it. Not to be in a rush like I was. Take it easy.” (Participant #01)
Participants also advised others to have an open mind when engaging in new or potentially daunting technology:
“Go in with an open mind. Don't be afraid of it because there might be a miracle at the end of it somewhere. You know, again something might click that, it didn't, it might not happen with me, but it could happen with them.” (Participant #09)
Participants identified that there was a need to trust the device, particularly with respect to balance and safety:
“Just go with it. Trusting. They're not going to fall over. The device will hold you up.” (Participant #10)
The need to be relaxed in the device was identified and it was established that when more relaxed the resultant walking was better. One participant advised:
“Try and relax. [Did you find it helpful when you relaxed?] Yeah.” (Participant #08)
Advice for health professions providing exoskeleton training
Participants identified that it would be beneficial for users of the device to have a clear idea of what was going to happen at every stage of use, and that advice should be given in concise, accessible, and non-clinical language.
“It could be explained to people in layman's terms…. What it would do” (Participant #09)
One participant stated physiotherapists should personally experience using the device which they felt would help the physiotherapist better understand the experience of patients:
“For them (physiotherapists) to use it first. To get into it and get the- get the- get the swing of it. To know what it's like. To feel how the patient will feel.” (Participant #10)
Overall participants felt the device was a useful addition to rehabilitation. One participant’s advice to physiotherapists was:
“Not to stop [using the device]” (Participant #05)
Likert scale results
Summary results of ratings of comfort when using the device and how natural walking in the device felt for each exoskeleton mode are depicted in table 3. Overall ratings of device comfort (mean rating 7.95; sd 1.4) and how natural walking felt (mean rating 7.05; sd 1.9) were favourable, with only one participant giving a rating below 5 on any scale (the natural feel of the device). This participant was able to ambulate independently with supervision at the time of data collection. Results indicate that participants rated walking in the device as more comfortable when walking in MA mode (mean Likert score 8.4) when compared to AA mode (mean Likert score 7.6). However, overall participants rated their gait as more natural when in AA mode (mean Likert score 7.3) when compared to MA mode (mean Likert score 6.8).
Table 3
Likert scale results
Question
|
Mode
|
Mean ± SD
|
|
How Comfortable?
|
Maximum Assist
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8.38 ± 1.06
|
|
How Comfortable?
|
Adaptive Assist
|
7.56 ± 1.59
|
|
How Natural?
|
Maximum Assist
|
6.75 ± 1.75
|
|
How Natural?
|
Adaptive Assist
|
7.33 ± 2.18
|
|
Note: Likert scale where 1= very uncomfortable and 10 = very comfortable or 1 = not natural at all and 10 = very natural
|
The relationship between both participants’ stroke-related ambulatory category as measured by the FAC and disability as measured by the mRS and the Likert rating scales were next explored using Spearmann’s correlation coefficient. Of note, a strong and positive relationship (rho=0.6) between the mRS and how natural walking in the device was rated in MA mode was identified, whereby the higher the level of disability, the more natural participants rated walking in the device in MA mode. A moderate and negative relationship was observed between FAC and how natural walking in the device was rated in MA, again meaning those more independent in ambulation (higher FAC), rated walking in in MA mode as less natural. Overall these trends point to more dependent individuals rating walking in the device as more natural. In contrast, a moderate positive relationship was found between FAC and comfort in AA mode, with a corresponding negative relationship for MRS, pointing to more physically independent and ambulatory participants rating the device as more comfortable when they could contribute to the movement.
Results from Spearman’s correlation coefficient of the relationship between ambulatory ability (FAC) and disability (mRS) and Likert scales in AA and MA mode can be found in table 4.
Table 4
Spearman's correlation coefficient results
Disability scale
|
Comfort MA
|
Comfort AA
|
Natural MA
|
Natural AA
|
|
rho
|
rho
|
rho
|
rho
|
FAC
|
0.09
|
0.36
|
-0.33
|
-0.18
|
mRS
|
0.06
|
-0.3
|
0.62
|
0.05
|
MA: maximum assistance; AA: Adapt assist; FAC: functional ambulatory category; mRS: modified Rankin scale for disability |