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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154371
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Göteborg University
Information provided by (Responsible Party):
Max Ortiz Catalan, Chalmers University of Technology

Brief 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.


Condition or disease Intervention/treatment Phase
Stroke Upper Extremity Dysfunction Device: Electromyography-controlled virtual and augmented reality using serious gaming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electromyography-controlled Virtual Reality and Serious Gaming to Improve Upper Extremity Function in Chronic Stroke Patients
Estimated Study Start Date : November 11, 2019
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 20, 2022

Arm Intervention/treatment
Experimental: Single-arm or non-randomized trial
Six post-stroke patients, in the chronic recovery stage, will receive a treatment in which motor execution is promoted by virtual and augmented reality using serious gaming controlled by myoelectric pattern recognition. The aim of this treatment is to improve upper limb functionality.
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.




Primary Outcome Measures :
  1. Upper Extremity Scale of Fugl-Meyer Assessment [ Time Frame: 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 ]
    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.

  2. Action Research Arm Test [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Kinematic Analysis [ Time Frame: 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 ]
    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).

  2. Embodiment Questionnaire [ Time Frame: 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 ]
    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.

  3. Thermography [ Time Frame: 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 ]
    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).

  4. Grip Strength [ Time Frame: 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 ]
    Grip strength (kg) will be measured with a handheld dynamometer.


Other Outcome Measures:
  1. ABILHAND [ Time Frame: 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 ]
    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.

  2. Stroke Impact Scale [ Time Frame: 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 ]
    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.

  3. Barthel Index [ Time Frame: 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 ]
    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.

  4. Offline Pattern Recognition Accuracy [ Time Frame: 3 times per week during intervention (6 weeks) ]
    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.

  5. Target Achievement Control Performance [ Time Frame: 3 times per week during intervention (6 weeks) ]
    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 (%).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154371


Contacts
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Contact: Max Ortiz Catalan, PhD +46708461065 maxo@chalmers.se

Locations
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Sweden
Chalmers University of Technology
Gothenburg, Sweden, 41701
Contact: Max Ortiz Catalan, PhD    +46708461065    maxo@chalmers.se   
Sponsors and Collaborators
Chalmers University of Technology
Sahlgrenska University Hospital, Sweden
Göteborg University
Investigators
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Principal Investigator: Max Ortiz Catalan, PHD Chalmers University
Publications:
Socialstyrelsen, "Statistical Database: In-Patient Care Diagnosis." [Online]. Available: http://www.socialstyrelsen.se/statistics/statisticaldatabase/. [Accessed: 14-Jan-2018].
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.

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Responsible Party: Max Ortiz Catalan, Associate Professor, Chalmers University of Technology
ClinicalTrials.gov Identifier: NCT04154371    
Other Study ID Numbers: BNL2019-1
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Max Ortiz Catalan, Chalmers University of Technology:
Electromyography
Virtual Reality
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases