Technical Feasibility of the implementation of an intensive upper-limb rehabilitation system (NeuroVirt) intervention for stroke survivors

doi:10.21203/rs.3.rs-4592110/v1

Background

80% of stroke survivors have upper limb (UL) disability. NeuroVirt is a portable immersive virtual reality (VR) platform that is designed to encourage high-repetition and high-quality UL movement training. The aim of the study is to investigate the technical feasibility, and the useability and acceptability of NeuroVirt.

Methods

8 adults with a stroke (≥ 3-months) completed the study. Participants used the device at home for up to two 1-hour sessions each day, 6 days a week, for 6 weeks. Participants also received a 15-minute weekly telephone call. Technical feasibility was measured by the percentage of Wi-Fi disconnections, data push failures, and mean scene frames per second (fps). Usability and acceptability were explored through interview feedback and analysed with a thematic inductive analysis approach. We also recorded the number of movement repetitions per session as an indication of compliance.

Results

From 12 participants enrolled in the study, 8 (67%) participants started the NeuroVirt exercise program and were included in the study analysis. Results indicated good Wi-Fi stability with 1(1.51%) disconnection out of 198 sessions, 1 (0.09%) push attempt failed out of 1052 data pushes and no data loss. An overall mean of 67.5 (2.27) fps during a session. Data from the interviews suggested that participants found NeuroVirt acceptable and indicated improvements in function. Participants completed on average 3.5 (1.3) sessions per week and performed on average 338.2 (172.7) movement repetitions per session.

Conclusion

NeuroVirt had no data loss and consistent Wi-Fi stability. The frame rate was above the minimum industry standards of 60-fps required to prevent motion sickness. Preliminary useability and acceptability results showed that a Home-based NeuroVirt program for stroke survivors with UL impairments was both, feasible and well accepted.

Trial registration:

registration number ISRCTN46051085; prospectively registered the 24/02/2023.

stroke

upper limb

virtual reality

rehabilitation

Stroke is a major cause of disability in the world (1) including in the United Kingdom (UK) where it is estimated that one in five people will have a stroke at some point in their lifetime (2). The consequence of a stroke is not only causing a substantial economic burden in society (£26 billion a year in the UK) (3) but also have a profound impact on the quality of life of stroke survivors and families (4).

Around 80% of stroke survivors suffer from an upper limb long-term disability (5). UL rehabilitation can be a lengthy process, and it may require hundreds of daily UL movement repetitions to enhance UL motor function after a stroke (6). Stroke rehabilitation usually commences in the hospital setting and extends beyond discharge. After being discharged from the hospital, stroke survivors feel abandoned (7), and their UL rehabilitation needs are not addressed (8).

Technological innovation aimed at improving adherence to higher-intensity self-therapy at home may increase the efficacy and efficiency of UL stroke rehabilitation in comparison to usual low-level care (9). As a result, there could be improvements in UL motor outcomes and quality of life. Moreover, it might decrease care requirements in the hospital alleviating healthcare systems bottlenecks and saving costs.

NeuroVirt is a fully immersive VR platform that is designed to encourage high- repetition UL movement training via games. The platform is designed for in clinic and home use. It allows users to be immersed in an engaging and challenging virtual scenario where the interaction emulates the exercises required in conventional therapy. It uses a VR headset to enable individuals to play games that involve moving their arm, wrist, hand, and fingers. NeuroVirt software has been co-designed with stroke survivors and clinicians and has been iteratively shaped through ongoing testing and feedback.

Conducting trials with new technologies has proven challenging because of technical bugs or hardware malfunction (10). This has disrupted the ability to gather robust clinical data needed to inform the development of future trials. We have therefore designed this study to test out the technical feasibility of the NeuroVirt platform within the context in which it was designed to be delivered. The aim of this study is to investigate the technical feasibility, safety, and the preliminary useability and acceptability of delivering a 6-week upper-limb rehabilitation intervention with the use of the NeuroVirt platform in stroke survivor´s own homes.

Trial design

This was a single-arm, non-randomised study. Participants that consented to be part of the study were assessed and taught how to use NeuroVirt in an-in-person session carried out by a therapist who specialises in working with people with stroke. If requested by the participant, the caregiver was also present during the session.

Following informed consent, included participants received a personalised UL exercise programme using the NeuroVirt system, based on the assessment findings. After the session, participants were provided with an instruction booklet and the NeuroVirt system to take home and use for six weeks. Following the six weeks, participants returned the NeuroVirt system and took part in a semi-structured interview. See Fig. 1 for flow chart of participants through the study.

Importantly, during the study period, participants were asked to continue with their daily routines, including rehabilitation therapy.

Participants and recruitment

Participants were recruited from across the south of England through an independent private rehabilitation company in two of their out-patient centres between February 2023 and June 2023. Inclusion criteria were: (1) aged 18 years or over; (2) a stroke (ischaemic or haemorrhagic) at least 3-months previously; (3) have at least a little motion of the upper limb, but not have full dexterity; (4) can navigate the NeuroVirt device independently following a trial during the first day with a researcher present; (5) can demonstrate wearing the NeuroVirt device independently at the first trial day OR a family member/carer is available on a daily basis to assist with applying the NeuroVirt device to the patient in their home ; (6) has at least a weak Wi-Fi connection at their home. Exclusion criteria were: (1) other neurological diagnoses; (2) communication, cognitive and language deficits such that they are unable to follow a one stage command and give informed consent; (3) frozen shoulder or other impairments affecting the movement of their arm such as arthritis; (4) any episode of photosensitive epilepsy within the last 12 months; (5) refuse to consent to GP being contacted.

Intervention

NeuroVirt is a fully immersive VR rehabilitation software and web-application platform, that is UKCA-marked as a medical device(Fig. 2). The NeuroVirt platform targets the entire upper-limb and includes six immersive training modules: three for Arm Reach (Buzz, Saw, Catch); one for all Wrist movements; one for Hand Extension which includes finger flexion and extension, and one for Grip Strength. NeuroVirt device includes adaptable straps for the hand controllers and a small ball to help clinicians tailor the therapy for each patient. Utilizing the Head-Mounted Display’s (HMD) cameras and positional sensors, the NeuroVirt software quantifies the angles of each joint of the hand and wrist as well as the position of the user’s arm relative to their body at 6 degrees of freedom. The artificial intelligence (AI) software adjusts to the patient’s impairment levels following a brief calibration process so that the games can be accessible for people with little or no movement recovery as well as those who have started to make a good recovery. Users receive in-game feedback as well as summary feedback on how well they have done at the end of their prescribed exercise session.

Participants were asked to set NeuroVirt up at home and undertake up to two 1-hour sessions each day, 6 days a week, for 6 weeks. The structure of each session consisted of 15 minutes warm-up of the hand and arm and up to a 45-minute training session using the NeuroVirt system. Participants could choose to play the rehabilitation games at a time that suited them, and they were advised to rest at any time and remove the HMD during any training session if needed.

Throughout the six-week intervention period, participants received a 15-minute weekly phone call from the therapist. During the call, participants were asked a standardized set of questions to ensure that they were managing the technology, and to monitor safety.

Measurement

Demographic and clinical data

Demographic (age, ethnicity, and sex) and clinical (stroke onset, stroke classification, UL impairment and activity, self-recorded exercise routine) characteristics were recorded. UL impairment was measured with the Fugl Meyer Assessment Upper Extremity (FMA-UE) (11) and UL activity was measured with the Chedoke Arm and Hand Activity Inventory-13 (CAHAI-13) (12). The FMA-UE has a scoring system from 0 to 126 points, higher scores indicating less impairment in the UL. The CAHAI-13 uses a scoring system from 0 to 96 higher scores indicating better activity in the UL. A visual analogue scale from 0 to 10 was used to measure participants' initial pain and fatigue levels (13).

Technical Feasibility

• Technical validation

We recorded NeuroVirt technical data in a cloud backend system following each session of use. To measure the average Wi-Fi connection stability, we recorded the device Wi-Fi connection and counted the number of disconnections that occurred during a session. To measure backend stability in multiple concurrent operations and NeuroVirt backup system, we monitored the number of data ‘push’ fails from total data pushes, as well as the percentage of successful uploads of previously failed-to-push data.

The frame rate is important to deliver simulator-sickness-free experience, to understand the performance of the application, we recorded the average frames per second during a session for each game modality.

From the weekly telephone calls and final interview, we collected information about any technical bugs present in the NeuroVirt system during the trial.

• Adherence and Duration of rehabilitation material

To assess the participants’ adherence, we collected data from the NeuroVirt System on the number of sessions completed by the participants in the 6-week period; the average duration of the sessions; and the number of movements per session. Additionally, we counted the number of times a participant removed the HMD during a session.

To assess the duration of the rehabilitation material provided by the NeuroVirt web-application platform, we recorded through the percentage of participants that completed all levels in each individual game, and the average time taken to complete each level of the games.

Safety

Safety was determined by an Adverse Event (AE) reporting system. In this study, we reported a Serious Adverse Event (SAE) if the AE resulted in death, a life-threatening injury, permanent impairment of a body structure or body function, or required hospitalization. A further vascular event and epileptic seizures were reported as expected disease-related adverse events unless their causality was determined to be as a result of the NeuroVirt intervention in which case they were also reported as SAEs. Treatment related adverse events were reported if the participant had pain following the NeuroVirt exercise, and which persisted for longer than 1 hour after the exercise program had stopped and could not be related to any other intervention.

Useability and acceptability feedback

To understand stroke survivors’ experience of using NeuroVirt, we collected useability and acceptability feedback through the weekly calls, and through face-to-face semi-structured interviews. We included questions about the NeuroVirt hardware, software, and instruction booklet. Questions to refine the protocol for a future trial were also included.

Data analysis

Quantitative data was analyzed using descriptive statistics, mean (standard deviation) and median (interquartile range) to describe continuous data, and percentages to describe categorical data. Qualitative data from the telephone calls and interviews was analysed by two researchers following a thematic inductive analysis approach. We applied the six phases of the thematic analysis described by Braun and Clarke ,2006 (14): (1) familiarizing oneself with the data, (2) generating codes, (3) constructing themes, (4) reviewing potential themes, (5) defining and naming themes, and (6) producing the report.

From 12 participants enrolled in the study, 4 (33%) people did not start the NeuroVirt exercise program, and 8 (67%) participants started the NeuroVirt exercise program. Reasons to not start the NeuroVirt program were not able to use NeuroVirt (n=1); did not want to take neuroVirt at home (n=2); took NeuroVirt at home, did not want to use it (n=1).

Eight participants were included in the study analysis. Participants mean age was 59. 25 (15.29) years old, 4 (50%) were female, mean time since last stroke was 2.86 (2.91) years, and with a FMA-UE mean score of 73.38 (28.42) (Table 1).

Table 1. Demographics and clinical characteristics of participants (N=8)

Age

Mean (SD), min-max

59.25 (15.29), 33-80

Ethnicity

White-British, n (%)

White-European, n (%)

7 (87.5)

1 (12.5)

Sex

Male, n (%)

Female, n (%)

4 (50)

Time since last stroke in months

Median (IQR), min-max

22 (15-68), 6-96

Stroke side

Left, n (%)

Right, n (%)

5 (62.50)

3 (37.50)

Stroke classification

ICH, n (%)

LACS, n (%)

PACS, n (%)

TACS, n (%)

4 (50)

1 (12.50)

2 (25)

Fugl-Meyer UL, mean (SD), min-max

73.38 (28.42), 13-108

CAHAI-13, mean (SD), min-max

36.75 (18.56), 19-78

Pain VAS, median (IQR)

0 (0-1)

Fatigue VAS, median (IQR)

2 (0.50-5.75)

Self-recorded exercise routine

Yes, n (%)

No, n (%)

6 (75)

2 (25)

Abbreviations: Intracerebral haemorrhage (ICH); Lacunar syndrome (LACS); Partial anterior circulation syndrome (PACS); Total anterior circulation syndrome (TACS); Upper Limb (UL); Chedoke Arm and Hand Activity Inventory-13 (CAHAI-13);Visual Analogue Scale (VAS).

Technical Feasibility

Technical Validation

The results on Wi-Fi stability showed that Wi-Fi disconnection occurred in 3 instances (1.51%) out of 198 sessions. From 1052 data pushes during the study, there was 1 (0.09%) failed push data attempt. The percentage of successful uploads of previously failed-to-push data was 100%, which indicates that there was 0% data loss during the study.

The results on frame rate showed that the NeuroVirt platform had an overall mean of 67.5 (2.27) fps during a session. Table 2 shows the mean frames per second during a session for each game modality.

Finally, two technical bugs in the NeuroVirt games were identified during the trial, one in the Arm Reach games calibration and the other in two final levels of the Hand Extension game.

Table 2. Frame Rate for each game.

Scene	Frames per second Mean (SD)
Lobby	68.24 (2.6)
Grip Strength	64.14 (4.1)
Hand Extension	66.40 (3.4)
Wrist	68.80 (2.0)
Arm Reach games	69.90 (2.0)

Performance and Duration of rehabilitation material

Performance: The mean (SD) sessions completed by participants in the 6 weeks period was 24.7 (9.5) sessions (minimum-maximum:10-36 sessions), equivalent to 3.5 (1.3) sessions per week. 188 (94.9%) out of 198 total sessions were completed in different days. The mean (SD) time on task was 20 (9.4) minutes per session (minimum-maximum: 6.6-31.8 minutes). The mean (SD) movements per session was 338.2 (172.7), (minimum-maximum: 133-605 movements). Figure 3 shows the number of movements per session for each participant. Two (25%) participants removed the HMD more than once during half or more of the sessions.

Figure 3. The graph shows the mean number of movements per session for each participant (N=8).

Duration of rehabilitation material: therapists prescribed the Hand Extension, Wrist, Arm Reach Saw and Arm reach Cath game to all 8 (100%) participants. Grip Strength and Arm Reach Buzz was prescribed to 6 (75%) participants. All the levels of the Wrist game were completed by 4 (50%) participants. 0 (0%) participants completed all levels in the Arm reach games, Hand Extension, or Grip game. The levels of the Arm Reach Buzz game were the longest to complete, 166 (164.3) seconds, (minimum-maximum: 15.9-452.6) whilst the levels of the Wrist game were the shortest to complete by the participants, 16.7 (4.7) seconds (minimum-maximum: 9-25.1). Table 3 for further information.

Table 3. Completion of developed rehabilitation material provided in the NeuroVirt system (N=8).

Games	Total number of levels	Reach level	Completed all levels	Seconds to complete each level
		Mean (SD), min-max	Number (%)	Mean (SD), min-max
Grip Strength	69 x 3 difficulty variations	7.3 (5.7), 4-19	0 (0)	32.1 (6.2), 23.6-40.6
Hand Extension	28 x 3 difficulty variations	18.8 (11.3), 2-28	0 (0)	90.4 (7.9), 73.1-99.1
Wrist	54	30.9 (24.8), 5-54	4 (50)	16.7 (4.7), 8.9-25.1
Arm Reach Buzz	Infinitely generating	-	0 (0)	166 .0(164.0), 15.9-452.6
Arm Reach Saw	Infinitely generating	-	0 (0)	85.3 (27.1), 59.7-136.1
Arm Reach Catch	Infinitely generating	-	0 (0)	104.2 (42.3), 61-144

Safety

No SAE or a treatment-related AE have been reported in this study.

Useability and acceptability

Useability is divided into three themes: 1) On boarding and User support, 2) Instruction Booklet, and 3) Additional support.

Acceptability is divided into two themes: 1) User satisfaction, and 2) Noticeable Physical and Non-physical impact.

Useability

On boarding and User support

In this theme we identified the types of support provided to the users.

Participants agreed that the face-to-face assessment and training session was useful to help them with setting NeuroVirt up at home. Some participants thought that one session was enough, and they did not ever look at the instruction booklet after the session. Others felt that they needed more training with one participant saying:

“Probably should have done more use in the beginning with a physio” (P.114).

During the interview it was found that not all participants that wore glasses were provided with the glasses´ adaptor, those participants reported that the use of the HMD without the glasses ‘ adaptor was uncomfortable.

Participants described the 15 minutes weekly telephone call as useful and long enough and frequent enough. Having a therapist checking up was also perceived as a motivator factor to complete the exercises.

“Yes, being accountable for stuff is really important for me so I think it has been good in that sense.”(P121)

Instruction Booklet

Participants felt that the information provided in the instruction booklet for the hardware and software setup and NeuroVirt App navigation was adequate. Some participants recommended that NeuroVirt create a section with more specific instructions for the games. The participants were happy with the format as they expressed their preference for printed training material.

“You know, I have an e-book reader, never use it, I prefer my stuff in hard print, but that’s the way my mind is wired”(P123)

Additional support

While many participants could independently operate the hardware, a few required assistances from their caregiver during the initial hardware setup. In contrast, when it came to the software, all participants indicated their dependence on caregiver support for its setup.

Participants that needed more support from the carer at the beginning, eventually starting to use NeuroVirt more independently. One family member of the participant stated:

“Towards the end you didn’t need me anywhere near really” (P.114 family)

Another family member said:

Come the last probably week, in the last week when you were using it, I would come into a room, she'd already be using it. Whereas before, we will sit down together, yes, we're doing this now” (P.112 family)

Acceptability

User satisfaction

Majority of participants reported to feel motivated with the NeuroVirt UL home-program. Some participants described their experience using words such as “really good” (P.112), or “really happy with it” (P.121). Some participants mentioned that a greater variety of games could enhance their motivation during training. Examples of proposed games by P.120 were formula one, football, rugby; P. 121 proposed games similar to the beat sabre game or the pong.

When participants were unable to progress in the game, feelings of frustration were also reported, sometimes followed by expressions of achievement. One participant reported:

“Now in all of those games, you have to complete fairly adequately the previous bits of the game to progress, and it wasn’t progressing beyond the middle of the jazz one and then one day it did. Hoorah, hoorah, and I thought oh thank god for that” (P.123).

The flexibility of the home-based program and portability of the device was perceived as positive because it allowed participants to fit the NeuroVirt training program into their daily routines. One participant said:

“ It fitted into the daily routine, yeah. I didn’t really… Well it just fitted in didn’t it?” (P.114)

Advantages identified in the context of immersing oneself in VR were that you do not realize that you are exercising and that participants felt that VR allowed them to do more movement repetitions than they would do otherwise. A challenge identified was that stroke survivors with severe sensory problems might struggle to discern the position of their arm within the immersive environment. Participants that reported cognitive or visual fatigue using the VR device had overcome this problem by splitting their exercise in two chunks, one participant stated:

“ I tended to do my exercises in two chunks” (P.123).

Noticeable Physical and Non-physical impact

All participants noticed motor improvements in their affected upper limb after using NeuroVirt for 6 weeks. Six of them, were confident that these enhancements were attributed to NeuroVirt. Many participants reported that their affected arm was getting stronger or more mobile while others also reported functional improvements. One participant stated:

“Yes. I think it is helpful, even when I am turning over in bed or something I think having that bit of extra movement is useful. Sometimes I wake up and I am laying on my arm and I can actually roll over and get my arm out now” (P.121).

Another participant commented:

“Oh. Carrying things is much more easy. I can carry things in my … my arm crooks and things … I can carry over my arm” (P.113)

In addition to motor improvements, two participants reported sleeping better, and one participant also expressed her view about the benefits of NeuroVirt for other stroke survivors,

“I can really see the benefits for others doing it” (P.114)

NeuroVirt is an immersive virtual reality (VR) platform that was designed to encourage high-movement-repetitions UL rehabilitation training via games. However, the delivering of an UL rehabilitation intervention with the use of NeuroVirt at stroke survivors’ own homes had not been tested. For that reason, the aim of the study was to investigate the technical feasibility, safety, and the preliminary useability and acceptability of delivering a 6-week upper-limb rehabilitation intervention with the use of the NeuroVirt system in stroke survivors´ own homes.

Technical feasibility

The results revealed that during the study, there were 3 (1.51%) instances of Wi-Fi disconnection out of 198 sessions conducted in participants' own homes. Additionally, only 1 (0.09%) instance out of 1052 data push attempts failed, resulting in 0% data loss. These results suggest that the NeuroVirt platform has a high-backed stability and consistent Wi-Fi stability.

The results on frame rate showed that the NeuroVirt platform had an overall mean of 67.5 (2.27) fps during a session. The frame rate during a session for each game modality was above the 60-fps minimum industry standards recommendation for VR devices (Jerdan et al., 2018). These results are important because evidence has shown that below 50 fps, gamers using VR are more likely to experience dizziness, headaches, nausea, fatigue, disorientation, and even pain (15).

Two technical bugs in the NeuroVirt games were promptly identified and resolved after the trial. While encountering technological issues in VR devices is not unusual, it is important to promptly detect and rectify them, as they can potentially lead to frustration for both therapists and patients (16,17).

Performance and Duration of rehabilitation material

In this study, participants trained the UL with NeuroVirt an average of 3.5 (1.3) sessions per week, and an average of 20 (9.4) minutes per session for a period of 6 weeks. These numbers are less than the 5 sessions per week, 45 minutes recommended in clinical guidelines for stroke survivors' rehabilitation programs (18). However, in our study, the 20 (9.4) minutes per session exercising the UL, is superior to the 4 minutes in a conventional PT session and 11 minutes in an OT session reported in previous literature (19). Additionally, our participants were a minimum of six months post-stroke where typically the amount of therapy that stroke survivors receive is scarce or non-existent (20) and compliance with a new exercise regime is likely to be less.

Regarding movement repetitions, we found that the mean (SD) number of UL movements per session was 338.2 (172.7) (minimum-maximum: 133-605 movements) which is in the range of movements recommended in previous studies to enhance UL recovery (21), and on average ten times more intensive and superior to the 35 UL movements repetitions performed in a conventional therapy session (19).

25% of participants removed the HMD more than once during half or more of the sessions. This is likely due to a combination of factors associated to VR devices, such as eye strain (22), and factors derived from the stroke such as post-stroke fatigue (23).

Safety, Useability, and acceptability

Safety

No serious adverse events or a treatment-related adverse event was reported in this study, suggesting that the 6-week NeuroVirt UL rehabilitation program at home is safe for stroke survivors.

Useability

Assistive technology devices that are suitable for home use and do not require professional supervision are more often utilized for stroke survivors (24). Our study shows that NeuroVirt is a device that could be used by stroke survivors to exercise the UL in their own houses with minimal contact with the therapist.

Participants described face-to-face training with a therapist before taking a NeuroVirt device home was useful. In this study, participants received one session of face-to-face NeuroVirt training, and some participants reported that it would be helpful to have more than one session. Similarly, one study that explored the use of a new VR device with stroke patients in their own homes found that 10% of the participants required a second training session before independent use of the device (22).

The comfort of using a VR device is important for engagement (24). A challenge identified in this study was the potential discomfort associated with wearing glasses while using the HMD. This matter should be addressed in a future study by providing the glasses adaptor, to each participant with glasses.

We found that the 15-minute weekly telephone calls were enough to facilitate use of the NeuroVirt platform at home and these served to provide motivation and technical support without face-to-face contact. Previous studies have also reported the positive effects of having a therapist checking on the patients to improve engagement in home exercise programs (9). If devices such as NeuroVirt are able to effectively support exercise delivery and adherence without face-to-face contact then there is significant potential for efficiency savings in the future, meaning more people may be able to access health services for longer.

For some people caregiver support was also identified as being important. In this study, we found that participants described needing more support from their caregiver at the beginning but were able to use the NeuroVirt platform independently towards the end of the six weeks. Feeling more independent is key for the majority of stroke survivors (25). Evaluation of NeuroVirt in future studies needs to include the impact that its use may have on caregivers. Use of the NeuroVirt platform could potentially improve a commonly underestimated problem after a stroke, which is the carer burnout (26).

Acceptability

In this study, NeuroVirt platform included 6 games, and some participants felt that more variety of games would help to improve motivation during training. This issue has been previously reported in other VR device studies (22). Before this article was finished NeuroVirt company added a new game into the platform.

In this study, participants reported that they were able to fit the UL training home program into their daily routines, albeit at doses that were less than prescribed. However, participants perceived that the fully immersive VR modality allowed them to do more movement repetitions that they would do with conventional therapy, perhaps because the focus during training with fully immersive VR tends to be on gaming rather than exercise (27). Interestingly, all participants who finished the six-week programme perceived UL motor improvements (functional or non-functional) after the 6-week program.

Nevertheless, additional research is essential to comprehensively assess the clinical and cost effectiveness of the NeuroVirt platform.

NeuroVirt immersive VR platform is safe to exercise the UL in stroke survivors’ own houses with minimal therapist support.

The results in technical feasibility found that the NeuroVirt platform is stable, and has consistent Wi-Fi stability, and the NeuroVirt scenes frame rate is above the 60 fps minimum industry standards.

Qualitative findings identified that the participants were able to train their affected UL with the NeuroVirt platform at home, the majority expressed feeling motivated during the program, and all perceived UL motor improvements after 6 weeks.

Subsequent studies using the NeuroVirt platform would benefit from enhancing the onboarding process by incorporating a minimum of two in-person training sessions for participants to become well-familiarized with the NeuroVirt platform before commencing the home program.

UL

upper limb

Fps

frames per second

UK

United Kingdom

VR

virtual reality

AI

artificial intelligence

FMA-UE

Fugl Meyer Assessment Upper Extremity

CAHAI-13

Chedoke Arm and Hand Activity Inventory-13

AE

adverse event

SAE

serious adverse event

Ethics approval and consent to participate: This study was approved by the University of East Anglia (Norwich Research Park, Norwich, NR4 7TJ, United Kingdom; All participants provided written informed consent.

Consent for publication: N/A

Availability of data and materials: The datasets generated and/or analysed during the current study are not publicly available

Competing interests: The rest of the authors declare that they have no competing interests. Evridiki Gregoriou is the Co-Founder & CEO at NeuroVirt, she was involved in the protocol creation and project coordination, but not in the data collection or analysis.

Funding Declaration: This study was funded by the NIHR i4i Connect, NIHR204467.

Authors' contributions:

KM: protocol creation, project coordinator, data analysis, major contributor in writing the manuscript

MRHM: data analysis, major contributor in writing the manuscript.

AW: protocol creation, project coordinator.

EG: protocol creation, project coordinator for technology use.

AC: protocol creation, data analysis, writing the manuscript.

All authors read and approved the final manuscript.

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Competing interest reported. The rest of the authors declare that they have no competing interests. Evridiki Gregoriou is the Co-Founder & CEO at NeuroVirt, she was involved in the protocol creation and project coordination, but not in the data collection or analysis.

Technical Feasibility of the implementation of an intensive upper-limb rehabilitation system (NeuroVirt) intervention for stroke survivors

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Trial registration:

Figures

INTRODUCTION

METHODS

Trial design

Participants and recruitment

Intervention

Measurement

Demographic and clinical data

Technical Feasibility

• Technical validation

• Adherence and Duration of rehabilitation material

Safety

Useability and acceptability feedback

Data analysis

RESULTS

DISCUSSION

CONCLUSION

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1