EMG-controlled Virtual Reality to Improve Upper Extremity Function in Chronic Stroke Patients

Stroke Clinical Trial

Official title:

Electromyography-controlled Virtual Reality and Serious Gaming to Improve Upper Extremity Function in Chronic Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04154371
• Other study ID #: BNL2019-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: December 20, 2022

Study information

• Verified date: March 2022
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single subject design study to investigate the effectiveness of electromyography-controlled virtual reality and serious gaming treatment on upper extremity functionality in patients in the chronic recovery stage after stroke.

The treatment consists of 18 sessions, 3 times per week, 2 hours each session.

The investigator's hypothesis is that this treatment will improve upper limb functionality in our study population, this outcome will be measured with Fugl-Meyer Upper-Extremity (FMA-UE) and Action Research Arm Test (ARAT) tests and Kinematic analysis. In addition, we expect to see an increase in the strength of the affected limb and an increase in the embodiment of the upper limb trained.

Description:

Background

The World Health Organization (WHO) defines stroke as rapidly developing clinical signs of focal or global disturbance of cerebral function, with symptoms lasting more than 24 hours or leading to death and with no apparent non-vascular cause. The incidence of stroke in Sweden is 300 cases per 100.000 inhabitants in a year of whom 200 suffer the first incidence of stroke leading to 18.000 new stroke victims. Of these, about 20% will die within the first month and about 1/3 of the survivors will remain significantly disabled after 6-12 months.

The upper extremity function is impaired after stroke in approximately 70-80% of patients in the acute phase and in 40% in chronic phase. This impairment limits the voluntary, well-coordinated, and effective movements as well as a person's level of activity and participation in their social and physical environment. This longstanding disability also affects the quality of life. Improved upper extremity function is one of the suggested areas for research by survivors of stroke.

Objectives

Primary Objective:

Investigate the effectiveness of electromyography-controlled augmented reality, and serious gaming on upper extremity functionality in patients in the chronic recovery stage after stroke, measure with FMA-UE and ARAT tests

Secondary Objectives:

• Investigate changes in the movement quality when performing a daily task using kinematic analysis and perceived difficulties in daily activities.

• Measure how strength changes on the affected limb after the treatment. Measure by a dynamometer.

• Measure with embodiment questioner if the treatment makes some changes on the embodiment of the affected limb.

• Measure with thermography the skin temperature differences between the affected and non-affected limb pre- and post-treatment.

Tertiary Objectives:

The tertiary objectives of this study are to investigate the effect of training on electromyography-based pattern recognition accuracy and Targeted Achievement Control scores, changes in kinematics, and changes in ABILHAND, Barthel index, muscle tone, and sensation scores in the affected limb over the recovery period.

Study Design

Inclusion and exclusion criteria for prospective patients will be addressed at the first measurement session. Baseline measurements will start at week 1 and, if necessary, inclusion and exclusion criteria will be reassessed.

Patients will undergo a single subject design (A-B-A-FU). Intervention stages are as follows:

A (Baseline). 2-3 weeks of no intervention with measurements taken once or twice per week, with a minimum of 3 assessments.

B (Intervention). 6 weeks of intervention three times per week with measurements taken once per week (18 sessions).

A (Reversal). 2-3 weeks of no intervention with measurements taken once or twice per week, with a minimum of 3 assessments.

FU (Follow-up). Follow-up measurements taken after 3 months without treatment.

Treatment Administration

Surface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. If no active sites can be determined, electrodes are placed along with major muscle groups regardless of activation. Electrodes are fixed to an electromyography recording device, and signal acquisition and processing software (BioPatRec) is used to record electromyography (EMG) signals and display feedback. EMG signals are observed, and the most active electrode locations are documented and used for further experiments.

The subject should attempt to perform different hand and arm movements with the extremity indicated by a nearby computer screen while the computer records EMG signals from the arm (referred to as offline training). Agonist-antagonist movement pairs should always be used in combination when selecting movements. Treatment sessions should start with one movement pair at a time and progress to multiple and simultaneous movements as treatment progresses and the patients perform better with the system.

The computer system recognizes the different movements while the computer system records closely related EMG signals and will perform the subject's intended movements with a computer-simulated upper extremity.

The subject will then use previously recorded movements to control a computer-simulated limb and attempt to match limb positions indicated on the computer screen. The system will measure how fast and how efficiently the subject reaches the target position with the simulated extremity Targeted Achievement Control (TAC Test). TAC tests will initially involve control over one degree of freedom at a time, e.g. rotation of the wrist or open/close hand movements. As the patient gains better control of their affected extremity and learn to use the system, the difficulty of the TAC Tests will be increased by adding additional and simultaneous movements.

Duration of the Treatment:

Each intervention session should take approximately two hours. The intervention stage of the trial will last six weeks with three sessions per week, total of 18 sessions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: December 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Able to sign an informed consent document

• Detectable muscle signals in the affected upper limb.

• Age between 18 and 80 years of age

• Montreal Cognitive Assessment test score of at least 22

• At least 6 months after stroke

• Experiencing upper-limb weakness, paralysis, or other loss of functionality

• Having a score below 50 on the Fugl-Meyer Assessment - Upper Extremity score

• Modified Ashworth score (0-5) of less than 3 pts

• Able to communicate and follow instructions needed for assessment and intervention adherence

Exclusion Criteria:

• Patients who are blind

• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

• Patients who have open wounds or other acute complications on their arms

Related Conditions & MeSH terms

• Stroke
• Upper Extremity Dysfunction

Intervention

Device:
• Electromyography-controlled virtual and augmented reality using serious gaming
Surface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. Electrodes are connected to an electromyography recording device, and signal acquisition and processing software are used to record EMG signals and display feedback. Myoelectric signals are used to control a virtual limb on the screen. The intervention consists of different steps: virtual reality, augmented reality, and serious gaming, which the participant must control with their muscle activity, record by EMG, in their affected limb.

Locations

Country	Name	City	State
Sweden	Chalmers University of Technology	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
Chalmers University of Technology	Göteborg University, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (17)

Alt Murphy M, Willén C, Sunnerhagen KS. Kinematic variables quantifying upper-extremity performance after stroke during reaching and drinking from a glass. Neurorehabil Neural Repair. 2011 Jan;25(1):71-80. doi: 10.1177/1545968310370748. Epub 2010 Sep 9. — View Citation

Duncan PW, Bode RK, Min Lai S, Perera S; Glycine Antagonist in Neuroprotection Americans Investigators. Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Arch Phys Med Rehabil. 2003 Jul;84(7):950-63. — View Citation

Fugl-Meyer AR, Jääskö L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31. — View Citation

Lang CE, Bland MD, Bailey RR, Schaefer SY, Birkenmeier RL. Assessment of upper extremity impairment, function, and activity after stroke: foundations for clinical decision making. J Hand Ther. 2013 Apr-Jun;26(2):104-14;quiz 115. doi: 10.1016/j.jht.2012.06.005. Epub 2012 Sep 10. Review. — View Citation

Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. — View Citation

M. CM, "Perceived losses following stroke," Rehabil. Nurs., 2000.

M. Klocek, "Quality of life after stroke," in Health-Related Quality of Life in Cardiovascular Patients, 2013.

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation

Moseley GL, Olthof N, Venema A, Don S, Wijers M, Gallace A, Spence C. Psychologically induced cooling of a specific body part caused by the illusory ownership of an artificial counterpart. Proc Natl Acad Sci U S A. 2008 Sep 2;105(35):13169-73. doi: 10.1073/pnas.0803768105. Epub 2008 Aug 25. — View Citation

Ortiz-Catalan M, Guðmundsdóttir RA, Kristoffersen MB, Zepeda-Echavarria A, Caine-Winterberger K, Kulbacka-Ortiz K, Widehammar C, Eriksson K, Stockselius A, Ragnö C, Pihlar Z, Burger H, Hermansson L. Phantom motor execution facilitated by machine learning and augmented reality as treatment for phantom limb pain: a single group, clinical trial in patients with chronic intractable phantom limb pain. Lancet. 2016 Dec 10;388(10062):2885-2894. doi: 10.1016/S0140-6736(16)31598-7. Epub 2016 Dec 2. — View Citation

Penta M, Tesio L, Arnould C, Zancan A, Thonnard JL. The ABILHAND questionnaire as a measure of manual ability in chronic stroke patients: Rasch-based validation and relationship to upper limb impairment. Stroke. 2001 Jul;32(7):1627-34. — View Citation

Perez-Marcos D. Virtual reality experiences, embodiment, videogames and their dimensions in neurorehabilitation. J Neuroeng Rehabil. 2018 Nov 26;15(1):113. doi: 10.1186/s12984-018-0461-0. — View Citation

Raffin E, Hummel FC. Restoring Motor Functions After Stroke: Multiple Approaches and Opportunities. Neuroscientist. 2018 Aug;24(4):400-416. doi: 10.1177/1073858417737486. Epub 2017 Nov 7. Review. — View Citation

Simon AM, Hargrove LJ, Lock BA, Kuiken TA. Target Achievement Control Test: evaluating real-time myoelectric pattern-recognition control of multifunctional upper-limb prostheses. J Rehabil Res Dev. 2011;48(6):619-27. — View Citation

Socialstyrelsen, "Statistical Database: In-Patient Care Diagnosis." [Online]. Available: http://www.socialstyrelsen.se/statistics/statisticaldatabase/. [Accessed: 14-Jan-2018].

Woodman P, Riazi A, Pereira C, Jones F. Social participation post stroke: a meta-ethnographic review of the experiences and views of community-dwelling stroke survivors. Disabil Rehabil. 2014;36(24):2031-43. doi: 10.3109/09638288.2014.887796. Epub 2014 Mar 6. Review. — View Citation

Woytowicz EJ, Rietschel JC, Goodman RN, Conroy SS, Sorkin JD, Whitall J, McCombe Waller S. Determining Levels of Upper Extremity Movement Impairment by Applying a Cluster Analysis to the Fugl-Meyer Assessment of the Upper Extremity in Chronic Stroke. Arch Phys Med Rehabil. 2017 Mar;98(3):456-462. doi: 10.1016/j.apmr.2016.06.023. Epub 2016 Aug 9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ABILHAND	The ABILHAND questionnaire that assesses perceived bimanual upper-limb ability (Penta, et al., 2001). The chronic stroke version includes 23 items rated on an ordinal 0-2 scale. The total score ranges from 0-46.	Once in the 3 weeks immediately prior to intervention, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Other	Stroke Impact Scale	The Stroke Impact Scale is a 60-item questionnaire that assesses perceived ability and functionality in 9 domains: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and communication and purpose, and recovery (Duncan, et al., 2003). Each domain is scaled linearly to a 0-100 score, with 100 being healthy.	Once in the 3 weeks immediately prior to intervention, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Other	Barthel Index	The Barthel Index is a 10-item questionnaire that assesses the ability to independently perform activities of daily living (Mahoney, et al., 1965). Each item is rated between 0-10, with 10 indicating ability to perform the task without assistance. The total score ranges between 0-100.	Once in the 3 weeks immediately prior to intervention, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Other	Offline Pattern Recognition Accuracy	The pattern recognition system used in the intervention is initialized with electromyographic data from sets of attempted movements of the affected arm. At the end of initialization, the offline accuracy of the system (in percent) is calculated as the number of correct movement predictions when the system is presented with a random sample of the recorded data. The score ranges from 0-100, with 100 indicating perfect performance.	3 times per week during intervention (6 weeks)
Other	Target Achievement Control Performance	The Target Achievement Control test is a 4-item metric that assesses the participant's ability to control the system used in the intervention (Simon, et al., 2011). A virtual limb is displayed on screen with a target posture, and the participant attempts to control a second virtual limb using physiologically appropriate muscle contractions. Metrics used are: selection time (ms), completion time (ms), completion rate (percent), and path efficiency (%).	3 times per week during intervention (6 weeks)
Primary	Upper Extremity Scale of Fugl-Meyer Assessment	The upper extremity portion of the Fugl-Meyer is a 33-item observational measure of upper limb function (Fugl-Meyer, et al., 1975). Each item is measured on an ordinal scale of 0-2 with 2 indicating normal functionality. The total score ranges from 0-66.	3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
Primary	Action Research Arm Test	The Action Research Arm Test is a 19-item observational measure of upper limb function (Lyle, 1981). Each item is measured on an ordinal scale of 0-3, with 3 indicating normal functionality. The total score ranges from 0-57.	3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention
Secondary	Kinematic Analysis	Kinematic analysis is a 4-item measure of upper-limb movement quality during a daily life activity (Murphy, et al., 2011). Items measured are movement time (seconds), movement smoothness (number of movement units), peak angular velocity of the elbow (mm per second), and maximum compensatory trunk displacement (cm).	Once in the 3 weeks immediately prior to intervention, once every other week during intervention at the beginning of the session, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Secondary	Embodiment Questionnaire	Perceived embodiment of the affected limb will be measured by a 6-item questionnaire. Each item is rated on a scale of 0 (completely disagree) to 7 (completely agree) regarding perception of agency and ownership of both the affected limb and the virtual limb used during the intervention. The total score ranges from 0-42.	Once in the 3 weeks immediately prior to intervention, once per week during the intervention at the end of the session, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Secondary	Thermography	The temperature difference (in degrees celsius) between the affected and non-affected limbs will be measured via thermographic camera. Healthy humans have a negligible difference between limbs, whereas an altered sense of embodiment may cause an increase in temperature difference (Moseley, et al., 2008).	Once in the 3 weeks immediately prior to intervention, once in the 3 weeks immediately after the end of intervention, and once more 3 months after the end of intervention
Secondary	Grip Strength	Grip strength (kg) will be measured with a handheld dynamometer.	3 times over 3 weeks immediately prior to intervention, once per week at the beginning of the session during intervention (6 weeks), 3 times over 3 weeks immediately after the end intervention, and once more 3 months after the end of intervention