1 Clinical Evaluation Curictus VRS Approval field Prepared Checked Approved Date Signature Mihaela Golic Daniel Goude Mihaela Golic Revision history Number of current revision Replaces Description of change revision 1 - - 2 1 3 2 Studies Added: nr 11 (Paretto et al) end 14 (Nilsson). Comments changed accordingly Added Pster (nr 15). Curictus Other documents / processes affected None. Conclusion not changed Effective Date Date of approval Date of approval Clinical Evaluation Curictus VRS Rev 3 2 Purpose The purpose of this document is to evaluate the safety and effectiveness of the Curictus VRS System, in helping the rehabilitation of patients with acquired brain injury. Background Intended Use Curictus VRS is a training / rehabilitation station. It is intended to be used by patients recovering after acquired brain injury, in carrying out arm/hand motor training and cognitive training Function Curictus VRS provides facilities for arm/hand motor training and cognitive training in a stimulating fashion, thus keeping the patient interested and motivated to persist with the training program, which is a key factor in the rehabilitation process. Design Curictus VRS is a semi-immersive system, making use of Virtual Reality and Haptics technology, in order to enhance the patient’s experience and facilitate learning / relearning processes. The training exercises are designed as “serios games”. Clinical Studies Clinical research has been conducted by researchers in rehabilitation at the Sahlgrenska University Hospital in Gothenburg and other institutions, without the involvement of Curictus. Method Analysis of available published data, with focus on the system’s safety and effectiveness. A summary of the published data is presented in Appendix 1. Curictus Clinical Evaluation Curictus VRS Rev 3 3 Comments 14 publications are presented, involving minimum 48+12+8 = 68 subjects. These numbers are indicated in the following publications: Physical Therapy Reviews 2009 VOL 14 NO 5, Haptic virtual rehabilitation in stroke: transferring research into clinical practice, Jurgen Broeren, Katharina S Sunnerhagen and Martin Rydmark”. Proc. 7th ICDVRAT with ArtAbilitation, Maia, Portugal, 2008, Virtual reality, haptics and post-stroke rehabilitation in practical therapy, L Pareto, J Broeren, D Goude, M Rydmark Linköping University, Faculty of Health Sciences, Occupational Therapy Programme, Specially developed computer games in virtual reality as a training method for persons with brain injury, Ingrid Nilsson The number may be bigger than that. Conclusions The analysis of the published data show that: - - Curictus Curictus VRS system is safe. No adverse events have been reported in any of the listed publication. Curictus VRS system is effective. A number of patients have reported improvements in the arm motor function and quality of life (Ref 4, 6, 10, 11, 12). It did not appear that age, sex or familiarity with computers play a role: the system was successfully used by younger and elder people, men and women, even with no previous computer familiarity (Ref 10, 11) Curictus VRS is easy to train to stroke patients and easy to use (Ref 9, 10) Clinical Evaluation Curictus VRS Rev 3 4 Appendix 1 Summary of the published data related to Curictus VRS System Nr 1 Reference Stud Health Technol Inform. 2002;85:434-7. Stroke rehabilitation at home using virtual reality, haptics and telemedicine. Rydmark M, Broeren J, Pascher R. http://www.ncbi.nlm.nih.gov /pubmed/15458128 2 Cyberpsychol Behav. 2002 Jun;5(3):207-11. Virtual reality and haptics as an assessment device in the postacute phase after stroke. Broeren J, Björkdahl A, Pascher R, Rydmark M. http://www.ncbi.nlm.nih.gov /pubmed/12123242 3 J Rehabil Med. 2003 May;(41 Suppl):7-10. Adaptive plasticity in motor cortex: implications for rehabilitation after brain injury. Curictus Purpose / Methods Subjects involved (number, type, characteristics) Results Conclusions Adverse events of VRS The objective of this pilot study is to identify the level of difficulty in which subjects with left hemisphere damage in the acute phase after stroke can start practicing in a virtual environment. Second, to test an application of Virtual Reality technology to existing occupational treatment methods in stroke rehabilitation and develop a platform for home rehabilitation controlled telemedically. Full article not reviewed The feasibility study setup is working well likewise the assessment method. Developing and increasing the complexity of the tasks must be based on the patient individual neurology, and that the cinematic motion patterns of the patient's are the basis for exercise design. The findings indicate that the system shows potential as an assessment and training device. None mentioned in the abstract This study describes how a haptic device was used as a cinematic assessment utility. Three chronic stroke inpatients at Sahlgrenska University Hospital with left hemisphere damage were assessed. The patients were administered by the box and block manual dexterity test. For comparisons, a reference group was added to the study. Several parameters, including time, speed, and movement of the right upper extremity, were extracted and evaluated. 3 chronic stroke patients The results indicate that the system shows potential as an assessment device. The feasibility study setup is working well, as is the assessment method. Further research, testing, refinement of the exercises, and use of VR and haptics within neurological rehabilitation are suggested. None mentioned It is now widely recognized that the cerebral cortex of adult human and non-human mammals is capable of widespread functional and structural plasticity. During the learning of new skills, cortical regions associated with sensorimotor function of the body parts most utilized for the skilled task Not applicable, review article Not applicable, review article These recent neuroscientific findings suggest that new rehabilitative interventions, both physiotherapeutic Not applicable, review article Clinical Evaluation Curictus VRS Rev 3 5 Nr Reference Nudo RJ. http://www.ncbi.nlm.nih.gov /pubmed/12817650 4 Arch Phys Med Rehabil. 2004 Aug;85(8):1247-50. Virtual reality and haptics as a training device for movement rehabilitation after stroke: a single-case study. Purpose / Methods Subjects involved (number, type, characteristics) come to be represented over larger cortical territories. More recent studies have shown that functional and structural changes take place in the cerebral cortex after injury, such as occurs after stroke or trauma. These two modulators of cortical function, sensorimotor learning and cortical injury, interact. Thus, after cortical injury, the structure and function of undamaged parts of the brain are remodeled during recovery, shaped by the sensorimotor experiences of the individual in the weeks to months following injury. To investigate whether training in a virtual environment with a haptic device will improve motor function in the left hemiparetic arm of a stroke subject. Three tests (Purdue pegboard test, dynamometer hand-grip strength, upper-extremity test) and a subjective interview were used to evaluate motor performance. Improvements were found in fine manual dexterity, grip force, and motor control of the affected upper extremity. The subject reported that there was a change in his day-to-day use of the upper extremity and that he was able to use it in activities that were previously impossible for him. Training with virtual reality and haptics can promote motor rehabilitation. None mentioned Full article not reviewed The benefits of a system for rehabilitation after stroke, based on VR, Haptics and Telemedicine should be: increased quality of life, lesser isolation, feeling more secure, fewer tiring transportations, The long term recovery for a larger group of patients with motor impairments is presently under None mentioned in the abstract The subject trained with a 3-dimensional computer game during a 4-week period that consisted of twelve 90-minute sessions Rehabilitation after stroke using virtual reality, haptics (force feedback) and telemedicine. Curictus We have constructed a haptic immersive workbench to be placed in the patients' home for daily adjusted rehabilitation. We also propose a system for Internet based connection and communication between patients and between patients and a clinical rehabilitation center and clinical Adverse events of VRS A man in his late fifties (right handed), with a right-hemisphere lesion that caused a deficit in the left upper extremity. http://www.ncbi.nlm.nih.gov /pubmed/15295748 Stud Health Technol Inform. 2006;124:51-6. Conclusions and pharmacotherapeut ic, may have benefit via modulation of neuroplastic mechanisms. Broeren J, Rydmark M, Sunnerhagen KS. 5 Results Clinical Evaluation Curictus VRS Rev 3 6 Nr Reference Broeren J, Dixon M, Sunnerhagen KS, Rydmark M. Purpose / Methods Subjects involved (number, type, characteristics) assessment/evaluation centers. http://www.ncbi.nlm.nih.gov /pubmed/17108503 6 Neurorehabil Neural Repair. 2007 MarApr;21(2):180-9. Assessment and training in a 3-dimensional virtual environment with haptics: a report on 5 cases of motor rehabilitation in the chronic stage after stroke. Broeren J, Rydmark M, Björkdahl A, Sunnerhagen KS. J Neuroeng Rehabil. 2007 May 9;4:13. A kinematic analysis of a haptic handheld stylus in a virtual environment: a study in healthy subjects. Broeren J, Sunnerhagen KS, Rydmark M. more frequent exercising, better compliance to training, lower cost for transportation. evaluation. Adverse events of VRS A single-subject repeatedmeasures experimental design (AB) was used. After baseline testing, 5 patients were assigned to the therapy 3 times a week for 45 min for 5 weeks. Velocity, time needed to reach, and hand path ratio (reflecting superfluous movements) were the outcome measures, along with the Assessment of Motor and Process Skills and the Box and Block test. The follow-up phase (C) occurred 12 weeks later. Improvements were noted in velocity, time, and hand path ratio. One patient showed improvement in occupational performance in ADLs. The application of this strategy of using virtual reality (VR) technologies may be useful in assessing and training stroke patients. The results of this study must be reproduced in further studies. The VR systems can be placed in homes or other nonclinical settings. None mentioned The objective of this study was to evaluate the test-retest reliability of a clinical procedure measuring trajectories with a haptic handheld stylus in a virtual environment and to establish normative data in healthy subjects using this haptic device. Fifty-eight normal subjects; aged from 20 to 69, performed 3 dimensional hand movements in a virtual environment using a haptic device on three occasions within one week. Test-retest stability and standardized normative data were obtained for all subjects. No difference was found between test and retest. The limits of agreement revealed that changes in an individual's performance could not be detected. There was a training effect between the first test occasion and the third test occasion. A new test was developed for recording the kinematics of the handheld haptic stylus in a virtual environment. The normative data will be used for purposes of comparison in future assessments, None mentioned http://www.ncbi.nlm.nih.gov /pmc/articles/PMC1877808/ Curictus Conclusions This exploratory study assessed the possible effectiveness of hemiparetic upper extremity training in subjects with chronic stroke with computer instrumentation (haptic force feedback) and 3-dimensional visualization applied to computer games, as well as to evaluate concurrent computer-assisted assessment of the kinematics of movements and test whether any improvement detected in the computer environment was reflected in activities of daily living (ADLs). http://nnr.sagepub.com/cont ent/21/2/180.abstract 7 Results Clinical Evaluation Curictus VRS Rev 3 7 Nr Reference Purpose / Methods Subjects involved (number, type, characteristics) Results Conclusions Adverse events of VRS such as before and after training of persons with neurological deficits. 8 Acta Neurol Scand. 2007 Sep;116(3):157-63. Neglect assessment as an application of virtual reality. In this study a cancellation task in a virtual environment was applied to describe the pattern of search and the kinematics of hand movements in eight patients with right hemisphere stroke. Four patients had visual neglect and four had recovered clinically from initial symptoms of neglect. The performance of the patients was compared with that of a control group consisting of eight subjects with no history of neurological deficits. Patients with neglect as well as patients clinically recovered from neglect showed aberrant search performance in the virtual reality (VR) task, such as mixed search pattern, repeated target pressures and deviating hand movements. The results indicate that in patients with a right hemispheric stroke, this VR application can provide an additional tool for assessment that can identify small variations otherwise not detectable with standard paperand-pencil tests. VR technology seems to be well suited for the assessment of visually guided manual exploration in space. None mentioned The purpose of this project was to investigate the effects of Virtual Reality technology and haptics for stroke rehabilitation. Twenty-nine stroke subjects, 17 women, and 12 men aged 44-85 years, participated in three different studies All participants responded favorable to the use of the VR activity station. A change of attitude took place after the subjects were exposed to playing computer games. The general experience with the VR application approach suggests that this treatment concept is promising in stroke None mentioned Broeren J, Samuelsson H, Stibrant-Sunnerhagen K, Blomstrand C, Rydmark M. http://www.ncbi.nlm.nih.gov /pubmed/17714328 9 Stud Health Technol Inform. 2008;136:77-82. Virtual rehabilitation after stroke. Broeren J, Bjorkdahl A, Claesson L, Goude D, Curictus Clinical Evaluation Curictus VRS Rev 3 8 Nr Reference Purpose / Methods Subjects involved (number, type, characteristics) Results Lundgren-Nilsson A, Samuelsson H, Blomstrand C, Sunnerhagen KS, Rydmark M. Conclusions Adverse events of VRS rehabilitation, with a wide range of applicability. http://www.ncbi.nlm.nih.gov /pubmed/18487711 10 Cerebrovasc Dis. 2008; 26(3): 289-96. Epub 2008 Jul 31. Virtual rehabilitation in an activity centre for community-dwelling persons with stroke. The possibilities of 3-dimensional computer games. Broeren J, Claesson L, Goude D, Rydmark M, Sunnerhagen KS. http://www.ncbi.nlm.nih.gov /pubmed/18667809 11 Proc. 7th ICDVRAT with ArtAbilitation, Maia, Portugal, 2008 Virtual reality, haptics and post-stroke rehabilitation in practical therapy L Pareto, J Broeren, D Goude, Curictus The main purpose of this study was to place a virtual reality (VR) system, designed to assess and to promote motor performance in the affected upper extremity in subjects after stroke, in a nonhospital environment. The intervention involved 11 patients after stroke who received extra rehabilitation by training on a computer 3 times a week during a 4-week period. The control group involved 11 patients after stroke who continued their previous rehabilitation (no extra computer training) during this period. The mean age of all was 68 years (range = 47-85) and the average time after stroke 66 months (range = 15-140). The VR training consisted of challenging games, which provided a range of difficulty levels that allow practice to be fun and motivating. An additional group of 11 right-handed aged matched individuals without history of neurological or psychiatric illnesses served as reference subjects Treatment group: 11 patients Control group: 11 patients Healthy volunteers: 11 (Total: 22 patients) All the participants reported that they were novel computer game players. After an initial introduction they learned to use the VR system quickly. The treatment group demonstrated improvements in motor outcome for the trained upper extremity, but this was not detected in real-life activities. The results of this research suggest the usefulness of computer games in training motor performance. VR can be used beneficially not only by younger participants but also by older persons to enhance their motor performance after stroke. . None mentioned We address the question of usefulness of virtual reality based rehabilitation equipment in practical therapy, by letting experienced therapists explore one such equipment during six months in their regular practice under natural circumstances. By protocols, questionnaires and focus group interviews 15 regular patients were judged to be suitable for the training in question, and were therefore offered this new training method. They all tried the equipment, but three patients chose to stay with their current training methods. The This resulted in a set of purposeful activities, identified values for therapeutic work, and design guidelines. The conclusion is that such equipment has benefits beyond real life training, that variation in content and None mentioned Clinical Evaluation Curictus VRS Rev 3 9 Nr 12 Reference Purpose / Methods Subjects involved (number, type, characteristics) M Rydmark http://www.icdvrat.reading.a c.uk/2008/papers/ICDVRAT2 008_S06_N04_Pareto_et_al.p df we collect data regarding which activities they considered useful, why these are useful and what might improve usefulness of such activities, based on the therapists’ professional judgement and experiences. remaining 12 subjects used the equipment according to their individual plan. Most subjects used the equipment for 1-2 hour sessions twice a week. Their respective training periods ranged from 3 to 12 weeks, depending on the remaining evaluation period and how long they wanted to proceed (for instance, one subject quit early due to family reasons). The age range varied from 20 to 85 years old, and was rather evenly distributed within that range. Four subjects were women and eight were men. Four subjects had other reasons for their disability than stroke. The non-stroke subjects suffered from fractures affecting upper limb mobility (2 subjects), burn injury or multiple sclerosis. Physical Therapy Reviews 2009 VOL 14 NO 5 Haptic virtual rehabilitation in stroke: transferring research into clinical practice Broerenj , StibrantSunnerhagen K, Rydmark M http://www.ingentaconnect.c om/content/maney/ptr/2009 /00000014/00000005/art000 04 The paper will give an overview of our work with a haptic immersive workbench which can be used in different setting for rehabilitation. Forty-eight subjects participated in three different experiments. Twenty-nine users had a stroke and 19 were healthy individuals. The intervention in the first two experiments consisted of playing three-dimensional computer games. A computerised task was developed to assess motor movement of the affected upper extremity. In the third experiment, a computerised visuospatial neglect test was developed and compared with traditional neglect tests. The subject 48 subjects Curictus Clinical Evaluation Curictus VRS Results Conclusions Adverse events of VRS difficulty levels is a key quality for wide suitability and that the combination of challenging cognitive activities which encourage motor training was considered particularly useful All experiments demonstrated that this haptic immersive workbench can provide a quantitative analysis of hand movements. The first experiment showed improvements in the computerised task. One subject improved in occupational performance, i.e. improvement reflected in activities of daily living. The second experiment was consistent with the first, but the results have extended these findings, showing that virtual rehabilitation can be The haptic immersive workbench features assessment methods and threedimensional computer games, which are adjustable with respect to degree of difficulty and users' abilities. For the future, we propose a system for Internet based connection and None mentioned Rev 3 10 Nr Reference Purpose / Methods Subjects involved (number, type, characteristics) hand position data (haptic stylus end-point, i.e. x-, y- and z-coordinates) was measured during each trial in the different experiments. 13 Proc. 8th Intl Conf. Disability, Virtual Reality & Associated Technologies Telehealth using 3 D Virtual Environments in Stroke rehabilitation - Work in Progress J Broeren, L Pareto, C Ljungberg, B Johansson, KS Sunnerhagen, M Rydmark http://www.tsoshop.co.uk/b ookstore.asp?Action=Book&P roductId=9780704915022 Curictus We have now started testing a telehealth system for stroke rehabilitation in a rural area in Sweden (NU- Hospital Group Area). For collection of assessments and audiovisual communication, the telehealth system has bidirectional contact with the home-based units. This project addresses two major problems within stroke rehabilitation. Firstly, it is a common problem that many subjects with stroke find the daily exercises that they are to perform at home are not very interesting and thereby lose motivation when they return home from the hospital. The second problem is that current methods require subjects with stroke to return to the hospital Three subjects were included in this study. All the subjects were living in the community in their own homes and were retired. They were referred from an occupational therapist from that primary care clinic and the referral criteria was 1) diagnosis of stroke; 2) hemiparesis in one of the upper extremities, that is, box and blocks score lower than 45 (Mathiowetz et al. 1985); 3) no signs of neglect; and 4) a minimum age of 70 years. Exclusion criteria for all subjects were 1) joint problems or prior injury to Clinical Evaluation Curictus VRS Results Conclusions beneficial not only to younger users but also to elderly people in terms of enhancing their motor performance. In the third experiment, we showed that the computerised visuospatial neglect test gave additional information compared to traditional tests. Both the subjects with neglect and the subjects clinically recovered from neglect showed aberrant search performance in the cancellation task in the virtual environment. communication between users and between users and rehabilitation centres. The benefits of a system for rehabilitation after stroke, employing telemedicine, haptics, 3Dvisualisation and serious-games should be more frequent exercising, better compliance with training in the home setting and improved quality of life. The data suggest that the intervention led to clinical changes in grip force (N) for S2 and S3. Manual ability, according to the BBT and ARAT improved for all three subjects (S1-S3). The subjects’ self-rated health status (EQ5D VAS score) increased for all three subjects (Table 2). The results of this study indicate that home rehabilitation is a promising approach in remote training and may have beneficial effects on quality of life. Further research is necessary to evaluate clinical efficacy and cost effectiveness with a larger population. Adverse events of VRS None mentioned Rev 3 11 Nr Reference 14 Linköping University, Faculty of Health Sciences, Occupational Therapy Programme Specially developed computer games in virtual reality as a training method for persons with brain injury Ingrid Nilsson http://www.lio.se/pages/472 93/cuppsats%20100216slutversio n.pdf 15 Poster presented at AT Forum, Götebrog, 6-8- April 2011 Hur patienter, nyinsjuknade i stroke, upplever användningen av virtual reality som behandlingsredskap http://www.curictus.com/wp content/uploads/2011/04/Po ster-AT-Forum-2011-VRS-iakut-stroke.pdf Curictus Purpose / Methods Subjects involved (number, type, characteristics) Results Conclusions Adverse events of VRS on a frequent basis for rehabilitation and to be monitored by hospital staff. Traveling to and from the hospital frequently poses a large cost to hospitals. arm/hand; 2) language difficulty that affects information reception. The aim of this study was to find out if computer training in virtual reality has an effect on cognitive functions in adult individuals with cognitive dysfunction following a brain injury. The study is quasiexperimental, observational study with a pre- and post design; the results are based on eight adult individuals. BNIS (Barrow Neurological Institute Screen) was used to assess cognitive function, before and after the period of training. When the training was completed, two open-ended questions were used to assess participants´ general experience of the training and whether acitivity performance had been affected. The training was carried out during a three-week period, with three training sessions per week. Att undersöka hur patienter, nyinsjuknade i stroke orsakad av infarkt, upplever användningen av virtual reality som behandlingsredskap. The results are based on eight adult individuals. Inclusions criteria: adults between 18-65 yrs, in chronic stage after brain injury, with cognitive dysfunction in one or more of the following areas: attention, construction and memory (according to the screening instrument Cognistat (Kiernan, Mueller, Langston %& van Dyke, 1987). The subjects must have had their brain injury more for more than 6 months ago, at recruitment time. The results from BNIS showed a significant positive change in cognitive function in seven out of the eight individuals.The biggest changes were shown in visuo-spatial functions. The indviduals found the training very positive but some expressed a sense of fatigue during training. One individual expressed a positive effect in daily activities. The results of this study show that cognitive functions might be improved by virtual reality computer training; Tiredness 10 män i åldern 57-88 år samtliga strokes orsakade av infarkt. Patienternas upplevda problem var nedsatt rörelse-och greppförmåga, känselstörning, synfältsbortfall, nedsatt finmotorik, koordination, koncentration, minne och reaktionsförmåga Majoriteten av de intervjuade patienterna förmedlade positiva upplevelser. Ett tema visade upplevelser med en känsla av flyt. Träningen gav en förändrad upplevelse av tid med fysiskt och mentalt engagemang. Två andra teman förmedlade positiva upplevelser av stimulans och delaktighet. Patienterna blev medvetna om sina problem och resurser, enträningsmedvetenhet Patienternas upplevelser visar att virtual reality är ett behandlingsredskap som kan användas för patienter nyinsjuknade i stroke orsakad av infarkt. Det optimala när någon typ av aktivitet eller träningsmoment skall Utföras är att uppleva en känsla av flyt med förändrad tidsupplevelse och kroppsligt och mentalt Några fysiska obehag upplevdes inte Clinical Evaluation Curictus VRS Rev 3 12 Nr Curictus Reference Purpose / Methods Subjects involved (number, type, characteristics) Clinical Evaluation Curictus VRS Results Conclusions framkom som gjorde patienten aktiv och kreativ. De kunde själva välja spel och svårighetsgrad och anpassa datorutrustningens och programmens utformning för att den skulle passa deras träningsbehov. Två patienter förmedlade en avsaknad av engagemang men en av dessa hade ändå ett positivt helhetsintryck.. engagemang vilket har visat sig kan uppnås med virtual reality. Även om det fanns patienter som saknade engagemang vid träning med dator och virtual reality teknik har inga faktorer framkommit som indikerar att tekniken inte kan användas som behandlingsredskap för flera patienter. Av vikt är att patienten har förståt ttekniken och syftet som då kan motivera till träning. Adverse events of VRS Rev 3