Robotics and functional electrical stimulation for stroke rehabilitation

Research area: Rehabilitation and occupational therapy

Duration: April 2020 – April 2021
Language: English (with German summary)

Publication: LBI-HTA Project Report No.: 128: https://eprints.aihta.at/1302

 

Background:

Post-stroke patients often suffer from a hemiparesis affecting the functional abilities of lower and/or upper extremities. Improving walking and everyday activities are therefore important rehabilitation goals for post-stroke patients with a hemiparesis [1, 2]

Robotic exoskeletons and functional electrostimulation (FES) can, among others, be used as a supplement to conventional rehabilitation in post-stroke patients. The use of exoskeletons and other robotic rehabilitation methods could have the advantage of allowing more intensive and frequent therapy (by increasing the motivation to train), which at the same time reduces the effort of the physiotherapist [3]. In addition, exoskeletons, for example when used for gait training, provide control strategies that support the stepping movement only when they detect an appropriate lateral weight shift. Therefore, active user involvement, such as foot placement, is required [4]. Further, FES is a targeted application of electrical stimulation inducing muscle contractions supporting motor activities. The electrical stimulation takes place during a functional movement and may, inter alia, strengthen the muscle and improve blood circulation or blood flow [5].

Yet, the additional clinical benefit of using robotic exoskeletons and FES in the rehabilitation of post-stoke patients with a hemiparesis is unclear. It is therefore necessary to clarify whether there is evidence showing a clinical benefit of these complementary rehabilitation procedures.

Aims of the project and research questions:

The project aims at evaluating whether there is a clinical benefit of using assisted exoskeletons or functional electrical stimulation (FES) in stroke rehabilitation when compared to standard rehabilitation alone in inpatient or outpatient settings. The following research questions (RQ) are to be answered:

·         RQ1: In post-stroke patients with a hemiparesis of upper or lower extremities, is rehabilitation with powered robotic exoskeletons more effective concerning activities of daily living/ability to walk independently and as safe concerning adverse events in comparison to standard rehabilitation in inpatient or outpatient settings?

·         RQ2: In post-stroke patients with a hemiparesis of upper or lower extremities, is rehabilitation with functional electrical stimulation (FES) more effective concerning activities of daily living/ability to walk independently and as safe concerning adverse events in comparison to standard rehabilitation in inpatient or outpatient settings

Inclusion criteria for rehabilitation with robotic exoskeletons in post-stroke patients suffering from a hemiparesis

Population	Patients who have had a stroke and suffer from hemiparesis of upper or   lower extremities
Intervention	Rehabilitation with powered robotic exoskeletons Product names (walking): Ekso GT (Ekso Bionics), HAL (Cyberdyne), ReWalk (ReWalk Robotics), Rex (RexBionics), Indego (Parker Hannifin Corp.) Product names (arm training): Armeo Power (Hocoma), Armeo Spring/T-WREX (Hocoma), products of Gloreha Rationale: Relevant interventions were informed by the policy question, reviews [6, 7]and a web-based manual search.
Control	Standard rehabilitation/care alone
Outcomes
Efficacy	Primary: Activities of daily living (ADL): e.g., Barthel Index, Functional independence Measure Ability to walk independently: e.g., Functional Ambulation Category (FAC)   Secondary: Body function and structure: e.g., FM – motor arm and leg tool Activity limitations: eg., Action Research Arm Test (ARAT) Walking test: e.g, Functional Ambulation Category (FAC), 10-m walk test  Muscle strength: e.g., Motricity Index Acceptance of training with exoskeletons: e.g., withdrawal/dropout rates   Rationale: Appropriate outcomes were informed by a manual search in the COMET  database, identified literature [8]and Cochrane systematic reviews [9, 10]
Safety	Adverse events Serious adverse events
Study design
Efficacy	Randomised controlled trials Prospective non-randomised controlled trials
Safety	Randomised controlled trials Prospective non-randomised controlled trials Observational studies with more than 100 patients
Settings	Inpatient or outpatient care

Inclusion criteria for FES in post-stroke patients suffering from a hemiparesis

Population	Patients who have had a stroke and suffer from hemiparesis of upper or  lower extremities
Intervention	Functional electrical stimulation (FES) in combination with standard rehabilitation Product names: MyndMove System (MyndTec Inc), WalkAide (Innovative Neurotronics Inc.), N.I. (Odstock Medical), products of Bioness ® Rationale: Relevant interventions were informed by the policy question and a web-based manual search.
Control	Standard rehabilitation/care alone
Outcomes
Efficacy	Primary: Activities of daily living (ADL): e.g., Barthel Index, Functional independence Measure Ability to walk independently: e.g., Functional Ambulation Category (FAC) Secondary: Body function and structure: e.g., FM – motor arm and leg tool Activity limitations: eg., Action Research Arm Test (ARAT) Walking test: e.g, Functional Ambulation Category (FAC), 10-m walk test Muscle strength: e.g., Motricity Index Rationale: Appropriate outcomes were informed by a manual search in the COMET database, subsequent identified literature [8]and a systematic review [11]
Safety	Adverse events Serious adverse events
Study design
Efficacy	Randomised controlled trials Prospective non-randomised controlled trials
Safety	Randomised controlled trials Prospective non-randomised controlled trials Observational studies with more than 100 patients
Settings	Inpatient or outpatient care

Methods:

·         A systematic literature search will be conducted in the following four databases (Cochrane (CENTRAL), Centre for Research and Dissemination (CRD), Embase, Ovid MEDLINE)

·         To strengthen the systematic search, a handsearch in reference lists of recent articles will be conducted and a web-based manual search will be conducted on relevant websites (e.g., UpToDate, exoskeletonreport.com).

The PRISMA statement [12, 13]and the EUnetHTA Core Model ® [14]will be used as reporting standards: Study selection (Screening of abstracts, and full-texts) will be conducted by two independent researcher (GG, MW). Critical appraisal (=risk of bias assessment) will be performed by two researchers (GG, MM) using adequate instruments: e.g., Cochrane Risk of Bias tool v.2 [15]for randomised trials, ROBINS-I for non-randomised controlled trials [16]. Relevant data from eligible studies will be systematically extracted into piloted data-extraction tables. Data will be extracted by GG and verified by MW.  A qualitative synthesis of the evidence will be conducted. Lastly, the Assessing the strength of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be utilised. All discrepancies will be resolved by consensus or by involving a third researcher in case it can not be resolved.

Timetable/ Milestones:

Period	Task
April/Mai 2020	Scoping, systematic literature search, Study selection
June 2020	Critical appraisal (=risk of bias assessment), data extraction, GRADE Assessment
July 2020	Writing the report
August 2020	Internal and external review, publication

References:

[1]            Dohle C., Tholen R., Wittenberg H., Quintern J., Saal S. and Stephan K. M. [Evidence-based rehabilitation of mobility after stroke]. Nervenarzt. 2016;87(10):1062-1067. Epub 2016/08/18. Evidenzbasierte Rehabilitation der Mobilität nach Schlaganfall. DOI: 10.1007/s00115-016-0188-8.
[2]            Harris J. E. and Eng J. J. Goal Priorities Identified through Client-Centred Measurement in Individuals with Chronic Stroke. Physiotherapy Canada Physiotherapie Canada. 2004;56(3):171-176. DOI: 10.2310/6640.2004.00017.
[3]            Hesse S., Schmidt H., Werner C. and Bardeleben A. Upper and lower extremity robotic devices for rehabilitation and for studying motor control. Curr Opin Neurol. 2003;16(6):705-710. Epub 2003/11/19. DOI: 10.1097/01.wco.0000102630.16692.38.
[4]           Louie D. R. and Eng J. J. Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Journal of neuroengineering and rehabilitation. 2016;13(1):53-53. DOI: 10.1186/s12984-016-0162-5.
[5]            Lynch C. and Popovic M. Functional Electrical Stimulation. Control Systems, IEEE. 2008;28:40-50. DOI: 10.1109/MCS.2007.914689.
[6]            Babaiasl M., Mahdioun S. H., Jaryani P. and Yazdani M. A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. Disabil Rehabil Assist Technol. 2016;11(4):263-280. Epub 2015/01/21. DOI: 10.3109/17483107.2014.1002539.
[7]            National Institute for Health and Care Excellence. Ekso exoskeleton for rehabilitation in people with neurological weakness or paralysis. 2017 [cited 23.04.2020]. Available from: https://www.nice.org.uk/advice/mib93.
[8]            Kwakkel G., Lannin N. A., Borschmann K., English C., Ali M., Churilov L., et al. Standardized measurement of sensorimotor recovery in stroke trials: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable. Int J Stroke. 2017;12(5):451-461. Epub 2017/07/13. DOI: 10.1177/1747493017711813.
[9]            Mehrholz J., Pohl M., Platz T., Kugler J. and Elsner B. Electromechanical and robot?assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database of Systematic Reviews. 2018(9). DOI: 10.1002/14651858.CD006876.pub5.
[10]          Mehrholz J., Thomas S., Werner C., Kugler J., Pohl M. and Elsner B. Electromechanical?assisted training for walking after stroke. Cochrane Database of Systematic Reviews. 2017(5). DOI: 10.1002/14651858.CD006185.pub4.
[11]          Eraifej J., Clark W., France B., Desando S. and Moore D. Effectiveness of upper limb functional electrical stimulation after stroke for the improvement of activities of daily living and motor function: a systematic review and meta-analysis. Syst Rev. 2017;6(1):40. Epub 2017/03/02. DOI: 10.1186/s13643-017-0435-5.
[12]          Liberati A., Altman D. G., Tetzlaff J., Mulrow C., Gøtzsche P. C., Ioannidis J. P. A., et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol. 2009;62(10):e1-e34. DOI: https://doi.org/10.1016/j.jclinepi.2009.06.006.
[13]          Moher D., Liberati A., Tetzlaff J. and Altman D. G. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. International Journal of Surgery. 2010;8(5):336-341. DOI: https://doi.org/10.1016/j.ijsu.2010.02.007.
[14]          EUnetHTA. Methodology Guidelines. 2015 [cited 01.02.2019]. Available from: https://www.eunethta.eu/methodology-guidelines/.
[15]          Sterne J. A. C., Savovi? J., Page M. J., Elbers R. G., Blencowe N. S., Boutron I., et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898. Epub 2019/08/30. DOI: 10.1136/bmj.l4898.
[16]          Sterne J. A., Hernán M. A., Reeves B. C., Savovi? J., Berkman N. D., Viswanathan M., et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919. Epub 2016/10/14. DOI: 10.1136/bmj.i4919.