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EMG Controlled Device in Acute Rehabilitation After Acute Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MARK
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Louis Stokes VA Medical Center, Cleveland, OHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feasibility

Arm Description

To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 9, 2020
Last Updated
September 12, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04599036
Brief Title
EMG Controlled Device in Acute Rehabilitation After Acute Stroke
Official Title
Myoelectrolytically Controlled Device in Acute Rehabilitation After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feasibility
Arm Type
Experimental
Arm Description
To explore if the feasibility of adding an EMG controlled device to the acute rehabilitation for stroke subjects with severe arm deficit.
Intervention Type
Device
Intervention Name(s)
MARK
Intervention Description
EMG controlled arm orthosis
Primary Outcome Measure Information:
Title
Changes in arm impairment using Fugl-Meyer assessment (FMA)
Description
Measure of arm impairment. Scores on the FMA may range from 0-66 points, with higher score indicating better performance.
Time Frame
Change from Baseline arm impairment after 6 weeks
Secondary Outcome Measure Information:
Title
Changes in arm function using Action Research Arm Test (ARAT)
Description
Measure of arm function. Scores on the ARAT may range from 0-57 points, with higher score indicating better performance.
Time Frame
Change from Baseline arm function after 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahlam Salameh, PhD MSc
Phone
(216) 791-3800
Ext
63417
Email
Ahlam.Salameh@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Holly B Henry
Phone
(216) 791-3800
Ext
64657
Email
holly.henry@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahlam Salameh, PhD MSc
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly B Henry
Phone
216-791-3800
Ext
64657
Email
holly.henry@va.gov
First Name & Middle Initial & Last Name & Degree
Neal S Peachey, PhD
Phone
(216) 421-3221
Email
neal.peachey@va.gov
First Name & Middle Initial & Last Name & Degree
Ahlam Salameh, PhD MSc

12. IPD Sharing Statement

Plan to Share IPD
No

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EMG Controlled Device in Acute Rehabilitation After Acute Stroke

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