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EMG Controlled Device in Acute Rehabilitation After Acute Stroke

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ClinicalTrials.gov Identifier: NCT04599036
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
Stroke is a medically relevant problem for the aging population. Individuals with stroke experience a high amount of arm functional deficits despite receiving rehabilitation. Functional deficits can be improved by combining rehabilitation with innovative rehabilitative tools that target the brain mechanisms that guide the recovery early after stroke. This study aims to explore the feasibility of implementing an EMG controlled device in the acute rehabilitation for stroke survivors with severe arm deficit. This study will determine if adding such a technology improve the clinical outcomes for subjects with severe arm impairments beyond the levels achieved by standard care in attempt to increase their chances to independently perform activities of daily living.

Condition or disease Intervention/treatment Phase
Stroke Device: MARK Not Applicable

Detailed Description:

During the first weeks after the onset of stroke, the injured brain undergoes several neural mechanisms, a process known as neuroplasticity, that intend to reorganize the neural connectivity and repair the damaged tissue around the injury region. Several studies revealed that rehabilitation during this acute period of injury would enhance the functional outcome of the paretic arm presumably by modulating the heightened neuroplastic mechanism. Specifically, it has been suggested that novel interventions that interact with the neuroplastic mechanisms of recovery are particularly needed for stroke survivors whom initial arm impairments are severe.

The rationale of this study is to explore if an EMG controlled device can be added to the acute rehabilitation for stroke subjects with severe arm deficit. The study will also investigate if the application of such a device would lead to an even better enhancement of clinical outcomes compared to standard care. Because of such neurophysiological changes during the acute phase, the study aims to correlate the neurophysiological changes with the enhancement gained as a result of practicing with an EMG controlled device in this population. Thus, test the premise that adding practice with an EMG controlled device to the acute rehabilitation of subjects with severe arm impairments acts as novel rehabilitative tool that interact with the neuroplastic mechanisms of recovery to enhance clinical outcomes for these subjects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Feasibility
To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.
 Device: MARK
EMG controlled arm orthosis


Outcome Measures
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Primary Outcome Measures :
  1. Changes in arm impairment using Fugl-Meyer assessment (FMA) [ Time Frame: Change from Baseline arm impairment after 6 weeks ]
    Measure of arm impairment. Scores on the FMA may range from 0-66 points, with higher score indicating better performance.


Secondary Outcome Measures :
  1. Changes in arm function using Action Research Arm Test (ARAT) [ Time Frame: Change from Baseline arm function after 6 weeks ]
    Measure of arm function. Scores on the ARAT may range from 0-57 points, with higher score indicating better performance.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans over 18 years of age
  • 2 days to 6 months since the onset of ischemic stroke
  • Adequate range of motion at the elbow, forearm, wrist, and hand to wear the device.
  • Ability to generate volitional, consistent, and detectable EMG signals from the upper arm and forearm sensor sites with wrist in neutral or flexed positions as detected by the Myopro software
  • MAS score 3 for the biceps, triceps, supinators and pronators of the impaired arm
  • Able to read and comprehend the English language
  • Able to follow directions
  • Medically and psychologically stable.

Exclusion Criteria:

Hemorrhagic stroke

  • Previous strokes affecting motor function on the opposite side.

  • Fugl-Meyer score of 2 on the following 3 items:

    1) finger mass extension, 2) grasp #1 test, and 3) shoulder flexion 90 - 180 degrees, elbow at 0 degree, and forearm neutral.

  • Shoulder subluxation, pain or dislocation
  • Shoulder passive range of motion < 45 degrees in flexion and abduction
  • Fixed upper limb contractures on the impaired arm and hand
  • Unable to safely support the weight of their arm plus 4 lbs (1.82 kg; the weight of the device) without pain even with arm supported.
  • Skin rash or open wound on impaired arm
  • Involuntary movements of the impaired arm
  • Pacemaker or other implanted devices
  • Metal in the skull
  • Claustrophobia, or inability to operate the MRI patient call button
  • Past history of seizures
  • Family history of medication refractory epilepsy
  • Chronic sleep deprivation, ongoing untreated sleep disorder
  • Pregnancy or pregnancy planning during the study period
  • Currently taking medications or substances that lower the threshold for onset of seizure.
  • Inability to understand English
Contacts and Locations
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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): NCT04599036


Contacts
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Contact: Ahlam Salameh, PhD MSc (216) 791-3800 ext 63417 Ahlam.Salameh@va.gov
Contact: Holly B Henry (216) 791-3800 ext 64657 holly.henry@va.gov

Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Holly B Henry    216-791-3800 ext 64657    holly.henry@va.gov   
Contact: Neal S Peachey, PhD    (216) 421-3221    neal.peachey@va.gov   
Principal Investigator: Ahlam Salameh, PhD MSc         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ahlam Salameh, PhD MSc Louis Stokes VA Medical Center, Cleveland, OH
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04599036    
Other Study ID Numbers: B3554-M
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
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: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases