EMG Controlled Device in Acute Rehabilitation After Acute Stroke

Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: MARK

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahlam Salameh, PhD MSc; Phone Number: 63417 (216) 791-3800; Email: Ahlam.Salameh@va.gov
• Study Contact Backup: Name: Holly B Henry; Phone Number: 64657 (216) 791-3800; Email: holly.henry@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Recruiting
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Principal Investigator: Ahlam Salameh, PhD MSc
      • Contact: Holly B Henry; Phone Number: 64657 216-791-3800; Email: holly.henry@va.gov
      • Contact: Neal S Peachey, PhD; Phone Number: (216) 421-3221; Email: neal.peachey@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Healthy Controls:

Over 18 years of age No history of neurological or muscular problems that affect arm function

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ahlam Salameh, PhD MSc, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B3554-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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