Application of a device for arm support in stroke rehabilitation: preparation of implementation in 7 Dutch rehabilitation centers

Transcription

1 Application of a device for arm support in stroke rehabilitation: preparation of implementation in 7 Dutch rehabilitation centers GB Prange, PhD; AIR Kottink, PhD; A Snoek, MSc; AHA Stienen, PhD; JH Buurke, PhD; JS Rietman, MD, PhD GB Prange, AIR Kottink, JH Buurke, JS Rietman Roessingh Research & Development Corresponding author: g.prange@rrd.nl AHA Stienen, JH Buurke, JS Rietman University of Twente A Snoek Snoek-Consultancy AHA Stienen Neuro Imaging and Motor Control Laboratory, Northwestern University Chicago (IL), USA Abstract Previous research of our group has led to the development of a relatively simple and cheap device for arm support (Freebal; now ArmeoBoom by Hocoma), which has shown potential to improve unsupported reaching after stroke. Therefore, we started a project to implement the ArmeoBoom device for arm support in stroke rehabilitation throughout the Netherlands (the ROBAR project). In this paper, we would like to present an implementation plan and share our initial experience during the preparation stage of the implementation. A plan for implementation is developed, encompassing three stages: preparation, execution, and evaluation. The goal of the preparation stage is to define the most suitable protocols and processes for implementation for each center specifically, starting from a generic plan, before the arm support device is actually implemented in clinical practice. The most important criteria to be addressed during preparation for all participating rehabilitation centers individually concerned selection criteria for eligible patients, the location where to place the ArmeoBoom in the center, and whether to add or replace therapy by the ArmeoBoom training. At the moment (January 2011), all involved therapists of the participating centers have started to use the ArmeoBoom during the arm rehabilitation of their subacute stroke subjects. After about 9 months of ArmeoBoom use, the execution of implementation will be evaluated. Keywords-arm support, stroke, upper extremity, clinical practice, implementation I. INTRODUCTION In stroke rehabilitation, exercises should be practiced preferably with high intensity, in a task-oriented way, with an active contribution of the stroke survivor in a motivating environment where feedback on performance and error is provided, to gain optimal results. A promising way to integrate these key elements of motor relearning into post stroke rehabilitation is the use of robotic systems. Due to these potential and rapid technological developments, robotics is increasingly used in rehabilitation, mainly in research settings. Application of rehabilitation robotics in clinical practice is up coming, but the extent to which robotics or other electromechanical devices are truly part of standard stroke rehabilitation is still limited. Several factors can limit use of sophisticated technology in neurorehabilitation, as has been identified for instance regarding virtual reality used as training environment.[1] Such factors also apply to robotic devices. Most systems, combining robotics with virtual reality, are high-tech and consist of expensive equipment. This requires extensive education for therapists and clinicians, and asks for (technical) expertise in maintenance. A low-tech and inexpensive device would be much more suitable for application in clinical practice. At the same time, the device should be easy to use and a concise, but complete instruction program should be provided for therapists and clinicians. Previous research of our group has led to the development of a relatively simple and cheap device for arm support (Freebal; now ArmeoBoom by Hocoma), which has shown potential to improve unsupported reaching after stroke [2-6], while being easy to use. Therefore, we started a project to implement the ArmeoBoom (figure 1) for arm support in stroke rehabilitation throughout the Netherlands (the ROBAR project: ROBotic Arm support for Rehabilitation in the early phase after stroke). In this paper, we would like to present an implementation plan to enhance use of a low-tech arm support device in stroke rehabilitation, and share our initial experience during the preparation stage of the implementation. The paper starts with background information to clarify choice of the device, after which the implementation plan is presented and our initial experience and results in executing the implementation plan are displayed.

2 Figure 1. ArmeoBoom for arm support in stroke patients II. BACKGROUND Every year, about 40,000 people in the Netherlands experience a stroke and over 200,000 people are currently living with the consequences of 1 or more strokes. With ageing, the chance to experience a stroke increases greatly. Recent data show that approximately 21% of the European population is over 60 years of age. With the graying of the population, it is expected that this percentage will increase to 26% in 2020 [ These demographic changes will cause a substantial increase in pressure on the healthcare systems. Almost half of all stroke patients has a limited arm function and only 5-20% of stroke survivors have functional use of the arm in daily life at 6 months post-stroke [7]. One of the mechanisms playing a role in the reduced coordination of arm/hand movements is the occurrence of involuntary, abnormal coupling between movements over multiple joints. In clinical practice, this is translated to a limitation of elbow extension during reach, which affects the execution of activities of daily living to a large extent [8]. Optimal restoration of motor function is essential to maximize independence in daily life. From literature is known that active initiation and execution of arm movements in meaningful environments with a high intensity of practice are crucial elements for optimal motor relearning of the hemiparetic arm after stroke [9-11]. A. Arm support Currently, intensive arm therapy is mainly provided through (semi-) individual therapy (1 therapist for 1 or a few patients). Possibilities for further intensification of therapy are difficult because of a limited availability of therapists. The last few decades, innovations in the field of robotics have enabled new ways to intensify rehabilitation. Using robotics, stroke patients can practice arm movements in an intensive, taskspecific, efficient and safe way, without additional employment of therapists. Besides this, such technology allows objective and reliable monitoring of patient progress. Recently, several systematic literature reviews have shown that robot-aided therapy has a positive effect on arm function of stroke patients [12-14]. In studies comparing robotic therapy with This implementation project is supported the Innovation Program of the Netherlands Association for Medical Rehabilitation (Revalidatie Nederland), and the Netherlands Organization for Health Research and Development (ZonMW), IPR conventional therapy, the robotic group has larger or faster improvements in arm function. Most of the contemporary robotic systems apply multiple training modalities (passive, active-assisted, active, resisted and/or bimanual movements) in the same training session. Often such training modalities are also combined with support of the arm. Several studies have shown that only supporting the weight of the arm can influence arm movement execution instantaneously, thereby contributing probably to the overall effect of robot-aided therapy. With arm support, the amount of generated shoulder elevation torques is decreased, leading to a less strong involuntary coupling between shoulder elevation and elbow flexion, which increases the planar active range of motion of stroke patients [15,16]. Also in 3D reaching movements, arm support, provided by the Freebal device [17], increases maximal reaching distance and work area [18-20]. This coincides with a lower activation of muscles, in both healthy elderly [21] and stroke patients [22], which indicates that arm support facilitates active arm movements. This instantaneous influence of arm support is translated to unsupported arm movements after a period of training with arm support. After 6 weeks of moderate intensity reach training with arm support by the Freebal (3 sessions of 30 minutes per week), maximal reach distance and work area (without any arm support) had improved [6,23]. This was accompanied by an increase in elbow extension. These training-induced changes are in line with a few other studies, applying varying methods of arm support [24-26]. Altogether, these findings so far indicate that the impact of arm support on unsupported reach performance using relatively simple devices is no less than robot-assisted exercises using a more complex, high-tech system. B. Independent training One of the major advantages of arm supported training over conventional rehabilitation is currently the possibility to automate the treatment; one therapist can supervise multiple patients at once, while they are practicing independently using arm support, especially in combination with motivating and challenging virtual environments or rehab games. The combination with virtual reality can further stimulate motor relearning. With the use of VR, it is possible to train intensively and to stimulate active participation using functional exercises. Also, multiple levels of difficulty can be presented for each exercise, allowing individually adjustable training programs. Furthermore, the possibility of adding augmented feedback to the exercises can stimulate the learning process, by making patients more aware of their performance [27]. With these tools, the VR context can be manipulated by the therapist to meet the key aspects related to motor recovery and motor relearning after stroke [28]. Several applications of VR applied in stroke rehabilitation have shown a positive effect on motor function [28]. In conclusion, application of arm support is a promising and suitable way to contribute to improvements in arm function during stroke rehabilitation. However, to attain actual use of arm support devices in clinical practice, such devices need to be (successfully) implemented in stroke rehabilitation on a

3 large scale. In order to do this, a plan for implementation must be developed and the implementation process needs to support transfer of knowledge from researchers to therapists and clinicians. III. PLAN FOR IMPLEMENTATION The current plan for implementation (PI) is developed by a collaboration between research institutes, Roessingh Research & Development (GP, AK, JB, JR) and the University of Twente (ASt), Enschede (the Netherlands), who were involved in development and experimental evaluation of the arm support device Freebal, a healthcare implementation specialist (ASn) and 7 renowned rehabilitation centers in the Netherlands with expertise on stroke rehabilitation (Roessingh Rehabilitation Center, Enschede; Groot Klimmendaal, Arnhem; Sint Maartenskliniek, Nijmegen; de Hoogstraat, Utrecht; Beatrixoord, Haren; Reade, Amsterdam; Rijndam, Rotterdam). All participating rehabilitation centers received their own ArmeoBoom as part of the implementation project. The ROBAR project (IPR ) has received funding from the Innovation Program of the Netherlands Association for Medical Rehabilitation (Revalidatie Nederland), and the Netherlands Organization for Health Research and Development (ZonMW). The PI encompasses three stages: preparation execution evaluation (see below). Stage 1 is discussed in this section and in the next section stages 2 and 3 are explained. Stage 1 Preparation of implementation 1. Organization and communication structure 2. Inventory of generic implementation options 3. Adaptations of generic plan to local context 4. Instruction of professionals (teaching the teacher) 5. Try-out in clinical practice 6. Determination of definite center-specific PI Stage 2 Execution of implementation 1. Teachers teaching their colleagues 2. Application of arm support device in practice 3. Collection of clinical and user experience data 4. Progress meeting(s) Stage 3 Evaluation of implementation 1. Analysis of clinical and user experience data 2. Evaluation meeting 3. Recommendations for implementation process 4. Dissemination of implementation plan and process A. Stage 1 Preparation of implementation The steps comprising preparation of the PI (stage 1) are presented below. The goal of this stage is to define the most suitable protocols and processes for implementation for each center specifically, starting from a generic plan. 1) Organization and communication structure In each rehabilitation center a local coordinator is appointed. This is a person with experience and a close connection with patient care in physical and/or occupational therapy. The local coordinators are supervised and advised by the project coordinator, who is one of the researchers from the research institute (RRD). The project coordinator initiates and manages the process of generic and center-specific implementation protocol inventory and determination. To establish a good communication between local and project coordinators, a communication structure is set in place. This is done through a website, which has an open access part with general project information and news, and a protected part with relevant project documents related to the contents of the implementation process, for all partners in the implementation project. In addition, visits of the project coordinator to the rehabilitation centers are scheduled during the first two stages to assess and discuss local situations. 2) Inventory of generic implementation options A generic implementation protocol is defined based on current scientific knowledge and experience from previous research. One part of this protocol comprises protocols for treatment and use of the ArmeoBoom, another part consists of questionnaires and tests to assess the impact of clinical use of the ArmeoBoom on technical, clinical, organizational, cultural and financial aspects. Special interest goes to user expectations and experience (usability, user acceptance, satisfaction, etc.). This generic protocol serves as a proposal to assess feasibility of application in each rehab center. 3) Adaptations of generic plan to local context Based on the proposed generic protocol, an inventory of feasibility for application of arm support is made by each center separately. Addressed issues include location of the device, planning of use of the device in clinical practice, planning of staff, informing of involved colleagues, etc. The outcome of the inventory gives input for adaptation to the generic plan, to accommodate differences in local context between the rehab centers. 4) Instruction of professionals Knowledge of the scientific background and the proper way to work with the arm support device based on research experience is demonstrated to the involved therapists and clinicians during instruction meetings. Also, the generic plan and potential adaptations for local context are discussed with the therapists and clinicians for further fine-tuning. In addition, questionnaires and tests to assess the impact of application of the arm support device in clinical practice are demonstrated to reach consensus on application and scoring. 5) Try-out in clinical practice During the try-out phase of several weeks, therapists can build experience in working with the arm support device, and

4 signal any potential problems in use of the system, planning of the arm support training in clinical practice, support of the process in rehabilitation organization, etc. Potential problems or points of attention are identified in this way, which are then taken into account in the generic and/or center-specific PI s. 6) Determination of definite center-specific PI During one of the instruction meetings, the experience and findings from the try-out phase are discussed between local coordinators and therapists and the project coordinator. Potential solutions are identified and inventoried, so that these become part of the generic and/or center-specific PI s, before the arm support device is actually implemented in clinical practice. Through these phases, a PI is identified for each center that is feasible, applicable in the corresponding situation(s) and agreed upon by the local coordinators, therapists and clinicians. This PI is written down in a book of reference for each rehabilitation center. An implementation process consisting of abovementioned phases generates sufficient support throughout the involved organizations to realize the goal of the implementation process: successful application of the arm support device in clinical practice. IV. PRELIMINARY EXPERIENCE Before using the ArmeoBoom in clinical practice by the involved therapists, different organizational aspects that are important for a successful implementation were inventoried by the project coordinator during stage 1 (preparation of implementation). A. Stage 1 Preparation of implementation This inventory took place in 5 steps: generic implementation options, adaptation to local context, discussion and instruction meeting, try-out in clinical practice, and finetuning of center-specific PI (steps 2-5 of stage 1). The contents of the inventory of the organizational aspects are presented in table 1. TABLE I. CONTENTS OF INVENTORY OF GENERIC PROTOCOL Category Examples 1. Selection criteria min. arm function; min. cognitive function 2. Location of device separate room/exercise room; care for device/laptop 3. Arm support training proximal/distal arm; adding/replacing therapy; frequency of therapy 4. People involved therapists, clinicians; management; planning; maintenance The most pronounced or remarkable findings on these inventory questions (Q) are discussed (answers; A), with a focus on generic aspects across centers and specific situations per center. a) Selection criteria Q: Criteria were specified, based on research experience, to define the patient population which is suitable for training their arm function with the ArmeoBoom. One of the most important criteria is the minimal arm function a patient must show to be able to use the arm support device. A: Minimal arm function is defined as 20 shoulder abduction and/or 20 elbow extension active independent range of motion. All participating centers agreed on this aspect. b) Location of ArmeoBoom Q: Based on research experience, the preference was to place the ArmeoBoom in a quiet exercise room. A: Not all participating centers were able to fulfill this criterion. Four centers placed the ArmeoBoom in a large exercise room (multiple patients treated in this room at the same time) and 3 centers placed the ArmeoBoom in a separate and quiet exercise room. c) Additional/replaced therapy Q: The project coordinator inventoried if the ArmeoBoom therapy could be given as additional therapy or if it should replace (partly) the current arm function therapy. The ArmeoBoom therapy spanned 6 weeks, during which subjects attended sessions 3 times per week for 30 minutes per session. A: Because of different reasons (i.e. limited availability of therapists, financial aspects), all participating rehabilitation centers had a preference to replace their current therapy by the ArmeoBoom therapy. One rehabilitation center replaced group therapy sessions with ArmeoBoom therapy, 4 centers replaced individual therapy sessions with ArmeoBoom therapy and 2 centers made a combination of both. V. PROGRESS OF IMPLEMENTATION At the moment of writing this paper, stage 1 has been completed and stage 2 is in progress. The subsequent activities in this implementation project and their progress are explained shortly in this section. A. Stage 2 Execution of implementation At the moment (January 2011), all involved therapists of the participating centers have instructed their colleagues who are going to work with the ArmeoBoom and have started to use the ArmeoBoom during the arm rehabilitation of their subacute stroke subjects. After about 9 months of ArmeoBoom use, the execution of implementation will be evaluated. To evaluate the success of implementation, both the involved patients and therapists of all participating centers are asked to fill in a questionnaire at the end of their participation. In this questionnaire special interest goes to user expectations and user acceptance (usability, satisfaction etc.). In addition, therapists and managers of the participating centers have to fill in a questionnaire which focuses on the technical, organizational, cultural and financial aspects of implementation. Besides this, the impact of arm support training on clinical scales is assessed.

5 B. Stage 3 Evaluation of implementation At the end of the execution of the implementation, data about clinical, technical, organizational, cultural and financial aspects are collected and analyzed. These findings will be discussed during an evaluation meeting. The response and feedback of the local coordinators will be used to promote the interpretation of the results in the right context. As a result of the data analysis and discussion at the evaluation meeting it can be assessed whether the executed implementation process has resulted in a successful implementation of the ArmeoBoom. If this is not the case, the plan of implementation will be adjusted and corresponding recommendations will be published and disseminated. ACKNOWLEDGMENT We would like to thank all clinical partners (Roessingh Rehabilitation Center, Enschede; Groot Klimmendaal, Arnhem; Sint Maartenskliniek, Nijmegen; de Hoogstraat, Utrecht; Beatrixoord, Haren; Reade, Amsterdam; Rijndam, Rotterdam) for their collaboration and valuable input during the preparation stage of the ROBAR implementation project so far. REFERENCES [1] Rizzo A and Kin G, "A SWOT analysis of the field of VR rehabilitation and therapy," Presence: Teleoperators and Virtual Environments, vol. 14, pp , [2] Stienen AHA, Hekman EEG, Prange GB, Jannink MJA, Van der Helm FCT, Van der Kooij H. Freebal: Design of a dedicated weight-support system for upper extremity rehabilitation. J Med Dev 2009;3(4):online pub [3] Prange GB, Stienen AHA, Jannink MJA, Van der Kooij H, IJzerman MJ, and Hermens HJ, "Increased range of motion and decreased muscle activity during maximal reach with gravity compensation in stroke patients," In: Proceedings of the 10th International Conference on Rehabilitation Robotics (ICORR), June 13-15, 2007, Noordwijk aan Zee, the Netherlands, pp (DOI /ICORR ). [4] Prange GB, Kallenberg LAC, Jannink MJA, Stienen AHA, Van der Kooij H et al., "Influence of gravity compensation on muscle activity during reach and retrieval in healthy elderly," J Electromyogr Kinesiol, vol. Epub ahead of print (DOI /j.jelekin ), [5] Prange GB, Jannink MJA, Stienen AHA, Van der Kooij H, IJzerman MJ, Hermens HJ. Influence of gravity compensation on muscle activation patterns during different temporal phases of arm movements of stroke patients. Neurorehabil Neural Repair 2009;23(5): [6] Prange GB, Krabben T, Renzenbrink GJ, de Boer J, Hermens HJ, and Jannink MJA. An explorative study into changes in reach performance after gravity compensation training in chronic stroke patients. In: Proceedings of the International Conference on Rehabilitation Robotics (ICORR) 2009; Kyoto, Japan: (DOI /ICORR ) [7] Kwakkel G, Kollen BJ, van der Grond J, Prevo AJH: Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke 2003, 34(9): [8] Beer RF, Dewald JPA, Dawson ML, Rymer WZ. Target-dependent differences between free and constrained arm movements in chronic hemiparesis. Exp Brain Res 2004;156: [9] Kwakkel G. Impact of intensity of practice after stroke: issues for consideration. Disabil Rehabil 2006;28(13-14): [10] Schaechter JD. Motor rehabilitation and brain plasticity after hemiparetic stroke. Prog Neurobiol 2004;73: [11] Barreca S, Wolf SL, Fasoli S, Bohannon R. Treatment interventions for the paretic upper limb of stroke survivors: a critical review. Neurorehabil Neural Repair 2003;17: [12] Prange GB, Jannink MJA, Groothuis-Oudshoorn CGM, Hermens HJ, IJzerman MJ: Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev 2006, 43(2): [13] Kwakkel G, Kollen BJ, Krebs HI: Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair 2008, 22(2): [14] Mehrholz J, Platz T, Kugler J, Pohl M: Electromechanical and robot-assisted arm training for improving arm function and activities of daily living after stroke. Cochrane Database Syst Rev 2008, 4:CD [15] Beer RF, Dewald JP, Dawson ML, Rymer WZ. Target-dependent differences between free and constrained arm movements in chronic hemiparesis. Exp Brain Res 2004;156(4): [16] Beer RF, Ellis MD, Holubar BG, Dewald JP. Impact of gravity loading on post-stroke reaching and its relationship to weakness. Muscle Nerve 2007;36(2): [17] Stienen AHA, Hekman EEG, Prange GB, Jannink MJA, Van der Helm FCT, Van der Kooij H. Freebal: Design of a dedicated weight-support system for upper extremity rehabilitation. J Med Dev 2009;3(4):online pub [18] Jannink MJA, Prange GB, Stienen AHA, Van der Kooij H, Kruitbosch JM, IJzerman MJ, et al. Reduction of muscle activity during repeated reach and retrieval with gravity compensation in stroke patients. In: Proceedings of International Conference on Rehabilitation Robotics (ICORR) 2007; Noordwijk., the Netherlands: (DOI /ICORR ) [19] Prange GB, Stienen AHA, Jannink MJA, Van der Kooij H, IJzerman MJ, Hermens HJ. Increased range of motion and decreased muscle activity during maximal reach with gravity compensation in stroke patients. In: Proceedings of International Conference on Rehabilitation Robotics (ICORR) 2007; Noordwijk., the Netherlands: (DOI /ICORR ) [20] Stienen AHA, Van der Helm FCT, Prange GB, Jannink MJA, Van der Kooij H. Effects of gravity compensation on the range-of-motion of the upper extremities in robotic rehabilitation after stroke. In: Proc Inter Shoulder Group 2006; Chicago (IL), USA [21] Prange GB, Kallenberg LAC, Jannink MJA, et al. Influence of gravity compensation on muscle activity during reach and retrieval in healthy elderly. J Electromyogr Kinesiol 2009; 19(2):e40-e49 [22] Prange GB, Jannink MJA, Stienen AHA, Van der Kooij H, IJzerman MJ, Hermens HJ. Influence of gravity compensation on muscle activation patterns during different temporal phases of arm movements of stroke patients. Neurorehabil Neural Repair 2009;23(5): [23] Van der Kooij H, Prange GB, Krabben T, Renzenbrink GJ, De Boer J, Hermens HJ, and Jannink MJA. Preliminary results of training with gravity compensation of the arm in chronic stroke survivors. In: Proceedings of IEEE Engineering in Medicine and Biology Society Conference (EMBC) 2009; Minneapolis (MN), USA: (DOI: /IEMBS ) [24] Sanchez RJ, Liu J, Rao S, et al. Automating arm movement training following severe stroke: functional exercises with quantitative feedback in a gravity-reduced environment. IEEE Trans Neural Syst Rehabil Eng 2006;14(3): [25] Housman SJ, Scott KM, Reinkensmeyer DJ. A randomized controlled trial of gravity-supported, computer-enhanced arm exercise for individuals with severe hemiparesis. Neurorehabil Neural Repair 2009;23(5): [26] Amirabdollahian F, Loureiro R, Gradwell E, Collin C, Harwin W, Johnson G. Multivariate analysis of the Fugl-Meyer outcome measures assessing the effectiveness of GENTLE/S robot-mediated stroke therapy. J NeuroEng Rehabil 2007;4:4 [27] Schmidt RA, Lee TD. Motor control and learning: a behavioral emphasis. Human Kinetics [28] Henderson A, Korner-Bitensky N, and Levin M, "Virtual reality in stroke rehabilitation: a systematic review of its effectiveness for upper limb motor recovery," Top Stroke Rehabil, vol. 14, pp , 2007.